Latest Industry News & Trends
Market Scope provides comprehensive coverage of the ophthalmic market. Our news stories are a combination of public and proprietary content ranging from coverage of international meetings, surgeon survey results and trends, analysis of company financial reports and public medical registries, press releases, and interviews with executives. Register today to receive free weekly email updates, our top data chart, surgeon poll results, and much more. Locked content can be accessed through a subscription to our ophthalmic industry newsletters.
Breaking News
Opthea Discontinues Wet AMD Trials After Second Phase III Trial Misses Endpoint
Opthea announced March 31 its decision to discontinue development of sozinibercept (OPT-302) in wet age-related macular degeneration (AMD) after a second Phase III trial missed its primary endpoint...
2024 Ophthalmic Revenue Roundup for Harrow, Astellas, Iridex, and Xbrane
Nashville, Tennessee-based Harrow reported March 27 that its 2024 revenue was $199.6 million, a 53 percent increase over $130.2 million in 2023. The company generated record quarterly revenue in Q4...
US FDA Again Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for Yet Another Symptom Trial
Aldeyra Therapeutics reported April 3 that the US FDA had once again issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment for d...
Malvina Eydelman, MD, Named CEO of CCOI Organization
Longtime US FDA regulator and board-certified ophthalmologist Malvina Eydelman, MD, has stepped into a new role as chief executive officer of the Collaborative Community on Ophthalmic Innovation (C...
Alcon Introduces Clareon PanOptix Pro Trifocal IOL
Alcon on April 2 introduced its Clareon PanOptix Pro trifocal IOL, a next-generation version of its groundbreaking PanOptix model. The company said the PanOptix Pro had been made available to selec...
Sydnexis Receives Positive CHMP Opinion for Low-Dose Atropine Drops in Pediatric Myopia
Sydnexis announced April 1 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for its low-dose ...
Topcon to Go Private Through Tender Offer by KKR and JIC Capital
Publicly held Topcon plans to go private under a $2.3 billion tender offer by private equity firm KKR, headquartered in New York, and JIC Capital, the private equity arm of Japan’s government-owned...
Rayner Doubles IOL Manufacturing Capacity with Expansion of Facility
Rayner announced April 2 that it had completed an expansion of its production facility in Worthing, UK, doubling the number of intraocular lenses (IOLs) it can manufacture annually to 4 million. Th...
Aviceda Appoints Jeffrey Nau, PhD, MMS, as Chief Executive Officer
Aviceda Therapeutics announced April 1 that it had appointed Jeffrey Nau, PhD, MMS, as chief executive officer, effective immediately. Nau will also join the company’s board of directors, Aviceda s...
Bausch + Lomb Recalls Certain enVista IOLs Amid Reports of TASS Cases
Bausch + Lomb announced March 27 that it was voluntarily recalling certain intraocular lenses (IOLs) on its enVista platform. A letter to customers from Bausch + Lomb Chairman and CEO Brent Saunder...
Alcon Announces Majority Ownership of Aurion
Alcon announced March 26 that it had acquired a majority interest in Aurion Biotech, developer of a corneal cell therapy. News of Alcon’s majority stake—after acquiring additional shares in Aurion ...
Alcon Agrees to Buy Lensar in Deal Worth up to $430 Million
Alcon announced March 24 that it had entered into a definitive agreement to acquire Lensar, including its Ally femtosecond laser cataract system, its Streamline software, and the Lensar legacy lase...
Opthea, Unity Candidates Miss Clinical Trial Endpoints vs. Aflibercept
Opthea and Unity Biotechnology reported results March 24 for their retinal treatment candidates that failed to meet or beat Regeneron’s Eylea (aflibercept) in clinical trials for wet AMD and DME, r...
Alcon Announces CE Mark Approval, European Launch of Clareon Vivity IOL
Alcon reported March 25 that the Clareon Vivity extended depth of focus (EDOF) intraocular lens (IOL) had received CE marking, along with the toric model, and will begin a commercial rollout in Eur...
Chinese Regulators Approve DORC’s ILM-Blue Ocular Dye
German company Carl Zeiss Meditec announced March 27 that China’s National Medical Products Administration (NMPA) had approved ILM-Blue ocular dye from DORC. The product is approved in the US as Ti...
Surrozen to Focus on Ophthalmic Pipeline, Raises up to $175 Million in Private Placement
Surrozen announced March 24 that it would focus on its ophthalmic pipeline, including the development of new treatment options for retinopathies. Concurrently, the company said that a private place...
Pantheon, Eyedeal Medical to Collaborate on Bioengineered Corneal Implant
Pantheon Vision announced March 27 that it would collaborate with Chinese ophthalmic device manufacturer Eyedeal Medical to advance the production and commercialization of Pantheon’s corneal implan...
Zeiss Launches Visulas Combi in Canada
Carl Zeiss Meditec announced March 21 the availability in Canada of the Visulas Combi, a green and YAG ophthalmic laser workstation combining photodisruption, photocoagulation, and slit lamp techno...
US FDA Expands Label for Iluvien to Include Chronic Non-infectious Posterior Uveitis
ANI Pharmaceuticals, of Baudette, Minnesota, announced March 14 that the US FDA had approved an expanded label for Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg) to include treatment...
Chinese Regulators Approve Innovent’s Sycume for Thyroid Eye Disease
China’s Innovent Biologics announced March 14 that Chinese regulators had approved Sycume, a recombinant anti-insulin-like growth factor 1 receptor antibody for thyroid eye disease (TED). Innovent ...
Eyenovia Weighs Potential All-Stock Reverse Merger with Betaliq
Eyenovia, of New York, reported March 20 that it was contemplating an all-stock reverse merger with Betaliq, of Tampa, Florida. The new, publicly listed company would combine Betaliq’s EyeSol water...
Thomas Panek to Lead Lighthouse Guild
Lighthouse Guild announced March 18 that it had appointed Thomas Panek as its new president and CEO, effective April 1. Panek replaces Calvin Roberts, MD, who has led the nonprofit since April 2020...
Xbrane to Sell Part of Company to Alvotech, Plans to Keep Ximluci
Sweden’s Xbrane will sell its Cimzia biosimilar candidate and parts of its organization to Iceland’s Alvotech for SEK 275 million ($27.1 million), the two companies reported March 20. Xbrane will r...
Vivani Now Intends to Spin Out Cortigent, Developer of Orion Implant
Vivani Medical, of Alameda, California, reported March 12 that it intends to spin off its Cortigent neurostimulation business, formerly Second Sight Medical Products, into a fully independent, publ...
Bausch + Lomb Launches Arise Orthokeratology Lens Fitting System in the US
Bausch + Lomb announced March 17 the US launch of Arise, a lens fitting system that uses cloud-based technology to streamline the orthokeratology lens design process. Orthokeratology (ortho-k) lens...
Cipla to Market Clobetasol Drops in 11 Countries, Including India, Under License with Formosa
Indian company Cipla has obtained exclusive rights to market clobetasol propionate eye drops in 11 countries, including India, for inflammation and pain following ocular surgery under a license agr...
Astellas, MBC BioLabs Offer Sixth Future Innovator Prize
Japan’s Astellas Pharma is again collaborating with MBC BioLabs, a launchpad for early-stage life-science companies, to offer the sixth Astellas Future Innovator Prize. The competition offers up to...
SIFI to Supply Akantior Drops for Investigator-Led Acanthamoeba Keratitis Trial
Italy’s SIFI announced March 18 that it will collaborate with the University of California, San Francisco (UCSF), in an investigator-led trial of patients with Acanthamoeba keratitis, a parasitic i...
2025-2026 Ophthalmic Meetings Calendar
Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.
US FDA Accepts NDA for Sydnexis’ Low-Dose Atropine for Myopia, Sets PDUFA Date of Oct. 23, 2025
Sydnexis, of Del Mar, California, reported March 11 that the US FDA had accepted its new drug application for SYD-101, a low-dose atropine eye drop to slow the progression of pediatric myopia. The ...
2024 Ophthalmic Revenue Roundup for Amgen and Biogen
Amgen, of Thousand Oaks, California, reported Feb. 4 that its 2024 revenue for Tepezza was $1.85 billion. 2024 was the first full year of Tepezza sales for Amgen after the company closed its acquis...
Study of Corneal Stem Cell Transplant Shows Vision Restored After Blinding Eye Injuries
A clinical study of patients with irreversible corneal injury, published March 4 in Nature Communications, showed that transplanted epithelial stem cells from their healthy eyes restored at least p...
Topcon, RadiusXR, and Glaukos Team Up to Launch Inspire VR Perimeter Headset
Topcon Healthcare, RadiusXR, and Glaukos announced March 11 that they are teaming up to launch RadiusXR’s new wearable vision testing platform, Inspire. The companies said the partnership capitaliz...
Early Study Shows Promise for Head-Mounted Retinal Surgery Robot
Researchers at the University of Utah’s John A. Moran Eye Center and John and Marcia Price College of Engineering reported Feb. 19 that they have collaborated to create a new robotic surgery device...
Deerfield Sues Alcon over Latest Moves to Prevent Aurion IPO
Deerfield Management has filed a lawsuit against an Alcon subsidiary, seeking to prevent Alcon from interfering with Aurion Biotech’s ability to launch an initial public offering. The lawsuit, file...
US FDA Grants Fast Track Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
Atsena Therapeutics announced March 12 that the US FDA had granted fast track designation to ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS). The candidate previously receive...
US FDA Approves Neurotech’s Cell Therapy Implant for MacTel
Neurotech Pharmaceuticals announced March 6 that the US FDA had approved Encelto, an encapsulated cell therapy implant to treat macular telangiectasia (MacTel) type 2. It’s the first FDA-approved t...
2024 Ophthalmic Revenue Roundup for Apellis, Immunocore, Sight Sciences, Ocular Therapeutix, Lensar, and ANI
Apellis Pharmaceuticals, of Waltham, Massachusetts, reported Feb. 28 that its 2024 net product revenue for Syfovre was $611.8 million, a 122.3 percent increase over $275.2 million in 2023. The comp...
MediPrint Ophthalmics Adds HA-Eluting Contact Lens to Pipeline
MediPrint Ophthalmics announced March 5 that it would expand its clinical program to address contact lens dropout due to discomfort with a drug-eluting contact lens that continuously delivers hyalu...
Outlook Resubmits BLA to US FDA for Ophthalmic Bevacizumab (Lytenava)
Outlook Therapeutics reported Feb. 28 that it had resubmitted its biologics license application (BLA) to the US FDA for ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-rel...
US FDA Approves ANI Pharmaceuticals’ Cortrophin Gel in Prefilled Syringe
ANI Pharmaceuticals announced March 3 that the US FDA had approved a prefilled syringe of its purified Cortrophin gel. Among its many indications, the treatment targets acute and chronic inflammato...
Avirmax Initiates IND-Enabling Studies of Dry AMD Triple-Gene Therapy Candidate
Avirmax Biopharma announced Feb. 28 that it had begun investigational new drug (IND) enabling studies of ABI-201, a viral vector that delivers three genes with the goal of preventing retinal pathog...
Japanese Regulators Grant Orphan Drug Status to HanAll’s Batoclimab in Active Thyroid Eye Disease
South Korea’s HanAll Biopharma announced March 6 that Japanese regulators had granted orphan drug designation to batoclimab, a subcutaneous anti-FcRn treatment being developed for autoimmune diseas...
Ocugen’s Gene Therapy Candidates for GA and Stargardt Gain Advanced Therapy Status in Europe
Ocugen announced March 3 that European regulators had granted advanced therapy medicinal product status to OCU410 and OCU410ST, the company’s subretinal gene therapy candidates for geographic atrop...
US FDA Accepts NDA for Glaukos’ Epioxa, Sets PDUFA Date of Oct. 20, 2025
Glaukos, of Aliso Viejo, California, reported Feb. 24 that the US FDA had accepted its new drug application for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy, for th...
2024 Ophthalmic Revenue Roundup for Alcon, Glaukos, Tarsus, and RxSight
Alcon reported Feb. 25 that its full year 2024 net sales totaled $9.8 billion, a 5 percent increase (+6 percent cc) over $9.4 billion in 2023. Q4-2024 sales were $2.5 billion, a 6 percent increase ...
Alcon Launches Systane Pro Preservative-Free Drops for Dry Eye in US
Alcon announced the US launch Feb. 24 of its Systane Pro Preservative-Free (PF) over-the-counter eye drops for dry eye. The company said Systane Pro PF is the longest lasting eye drop in the Systan...
STAAR Appoints Stephen C. Farrell as President, CEO; Tom Frinzi to Remain as Adviser Through January 2026
STAAR Surgical announced Feb. 26 that Stephen C. Farrell, current lead independent director of the company’s board, has been appointed president and CEO. Farrell succeeds ophthalmic industry vetera...
Chinese Regulators Approve Zeiss’ VisuMax 800 with SMILE Pro Software
Germany’s Carl Zeiss Meditec announced Feb. 26 that the National Medical Products Administration in China had approved its updated VisuMax 800 femtosecond refractive laser and related SMILE Pro sof...
Formycon, Klinge Gain UK Approval for Eylea Biosimilar Under Brand Name Ahzantive
German companies Formycon and Klinge Biopharma announced Feb. 25 that the UK’s Medicines and Healthcare Products Regulatory Agency had granted marketing authorization for their Eylea biosimilar und...
Seonix Bio Launches SightScore Saliva Test for Glaucoma Risk in US
Seonix Bio announced Feb. 20 the US launch of SightScore, the first commercially available clinical polygenic risk score testing service for primary open-angle glaucoma. Seonix, an Australian compa...
Chinese Regulators Accept NDA for Arcatus (Xipere) in Uveitic Macular Edema
Clearside Biomedical announced Feb. 20 that Chinese regulators had accepted for review the new drug application (NDA) filed by Clearside’s Asia-Pacific partner, Arctic Vision, for Arcatus, known as...
Opus Gains FDA Fast Track Status for Phentolamine Drops for Night Driving Impairment
Opus Genetics announced Feb. 26 that the US FDA had granted fast track designation to the company’s phentolamine eye drop candidate for night driving impairment in keratorefractive patients. Ocuphi...
New World Medical Gains US 510(k) Clearance for the Via360 Viscodilation System for Glaucoma
New World Medical announced Feb. 18 that it had received 510(k) clearance from the US FDA for its Via360 glaucoma surgical system. The Rancho Cucamonga, California, company said the device would be...
Bausch + Lomb Posts 2024 Revenue of $4.8 Billion
Bausch + Lomb reported Feb. 19 that its 2024 revenue totaled $4.8 billion, a 16 percent increase (+17 percent cc) over $4.1 billion in 2023. The company’s Q4-2024 revenue was $1.3 billion, a 9 perc...
Alcon Announces US Launch of Voyager DSLT for Glaucoma
Alcon announced Feb. 19 the full US commercial launch of the Voyager laser for direct selective laser trabeculoplasty (DSLT). The company said attendees of the American Glaucoma Society meeting in ...
Celltrion Gains EU Approval for Aflibercept Biosimilar Branded Eydenzelt
South Korea’s Celltrion announced Feb. 18 that the European Commission had granted marketing authorization to Eydenzelt, an aflibercept (Eylea) biosimilar. Eydenzelt (40 mg/mL solution for injectio...
US FDA Grants RMAT Designation for Bionic Sight’s RP Gene Therapy Candidate
Bionic Sight announced Feb. 18 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to BS01, the company’s gene therapy candidate targeting retinitis pigmentosa (RP...
Optos Unveils MonacoPro Ultra-Widefield Retinal Imager with SD-OCT
Optos, a division of Nikon, announced Feb. 14 the launch of the MonacoPro, its next-generation ultra-widefield scanning laser ophthalmoscope with integrated spectral domain optical coherence tomogr...
US FDA Accepts BLA for Aflibercept Biosimilar Candidate from Alvotech, Teva
Alvotech announced Feb. 18 that the US FDA had accepted for review its biologics license application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept). The company said it expe...
US FDA Grants RMAT Designation for Luxa’s Dry AMD Cell Therapy Candidate
Luxa Biotechnology, a joint venture between Korea’s Y2 Solutions and the Neural Stem Cell Institute in Rensselaer, New York, announced Feb. 18 that the US FDA had granted regenerative medicine adva...
US FDA Approves Expanded Label for Izervay to Extend Treatment for GA Beyond 12 Months
Japan’s Astellas Pharma announced Feb. 12 that the US FDA had approved expanded labeling for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy (GA), extending the allowed du...
2024 and Quarterly Ophthalmic Revenue Roundup for Regeneron, Carl Zeiss Meditec, Hoya, and STAAR
Regeneron, of Tarrytown, New York, reported Feb. 4 that its 2024 US revenue for Eylea 2 mg (aflibercept 2 mg) and Eylea HD (aflibercept 8 mg) totaled nearly $5.97 billion, a 1 percent increase over...
EssilorLuxottica Acquires Canadian Retinal Camera Maker Cellview Imaging
Eyewear conglomerate EssilorLuxottica announced Feb. 11 that it had acquired Cellview Imaging, a Canadian startup specializing in ultra-widefield retinal diagnostics. Cellview’s WRI-1 fundus camera...
Acelyrin to Merge with Alumis in All-Stock Transaction
Acelyrin, which was developing lonigutamab, a subcutaneous treatment candidate for thyroid eye disease (TED), announced Feb. 6 that it would merge with Alumis in an all-stock transaction. The combi...
US FDA Grants RMAT Designation for Beacon’s XLRP Gene Therapy Candidate
Beacon Therapeutics announced Jan. 28 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to laru-zova (laruparetigene zovaparvovec, also known as AGTC-501), Beaco...
Ocugen’s RP Gene Therapy Candidate Gains Advanced Therapy Status in Europe
Ocugen announced Feb. 3 that European regulators had granted advanced therapy medicinal product status to OCU400, a modifier gene therapy candidate for retinitis pigmentosa (RP). OCU400 (AAV-NR2E3)...
Kala Bio’s CEO Resigns; President, COO Takes Over as Interim
Kala Bio announced Feb. 12 that its chief executive officer, Mark Iwicki, had resigned, and that Todd Bazemore, Kala’s president and chief operating officer, had been appointed interim CEO, effecti...
Bausch + Lomb Rules Out Sale After Concluding Bid Process
Bausch + Lomb announced Feb. 6 that it had ruled out a sale of the company, after exploring the option in its bid for a full separation from parent company Bausch Health. “Taking Bausch + Lomb priv...
Appeals Court Upholds Injunctions Blocking Eylea Biosimilars from Samsung Bioepis and Formycon
In a victory for Regeneron, the US Court of Appeals for the Federal Circuit issued a ruling Jan. 29 upholding preliminary injunctions that block Samsung Bioepis and Formycon from launching their ap...
2024 Ophthalmic Revenue Roundup for Roche, AbbVie, Novartis
Swiss company Roche reported Jan. 29 that global sales of Vabysmo for 2024 were CHF 3.86 billion ($4.25 billion, converted Jan. 29, 2025), a 63.6 percent increase (+68 percent cc) over CHF 2.36 bil...
US FDA Approves Genentech’s Susvimo Refillable Implant for DME
Genentech, a member of the Roche Group, announced Feb. 4 that the US FDA had approved Susvimo, a refillable ranibizumab implant, for diabetic macular edema (DME). The company said Susvimo is now av...
Australian Regulators Approve Apellis’ Syfovre for Geographic Atrophy
Apellis Pharmaceuticals announced Jan. 27 that Australia’s Therapeutic Goods Administration had approved Syfovre (intravitreal pegcetacoplan) for the every-other-month treatment of adult patients w...
Harrow, Cencora Partner to Improve Drug Access for Retina Specialists, Patients
Drugmaker Harrow reported Jan. 27 that it had partnered with Cencora to launch a program called “Harrow Cares,” with the goal of making Harrow products iHeezo and Triesence more accessible and affo...
Iantrek Appoints Adam Szaronos as Chief Executive Officer
Iantrek announced Feb. 4 that it had appointed Adam Szaronos as its new chief executive officer. Szaronos succeeds company founder and innovator Sean Ianchulev, MD, MPH, who will remain as chairman...
Aflibercept Biosimilar Candidate from Amgen Gains Positive CHMP Opinion
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion Jan. 30 for an aflibercept (Eylea) biosimilar from Amgen, under the names Pavblu and Skojoy. The biosimilar ...
Chinese Regulators Accept Marketing Application for Zhaoke’s Low-Dose Atropine Drop for Myopia
Vyluma announced Jan. 29 that China’s National Medical Products Administration had accepted the marketing application from Zhaoke Ophthalmology for NVK002 (low-dose atropine 0.01%) targeting myopia...
2024 Ophthalmic Revenue Roundup for J&J Vision, Lumibird, and Nicox
Johnson & Johnson reported Jan. 22 that its full year 2024 global surgical vision revenue was $1.41 billion, a 3.2 percent increase (+4.3 percent cc) over $1.37 billion in 2023. Revenue was down 3....
Norlase Receives US Clearance and CE Marking for Lynx Pattern Scanning Laser Indirect Ophthalmoscope
Norlase announced Jan. 27 the commercial launch of the Lynx, which the company says is the world’s first laser indirect ophthalmoscope with integrated pattern scanning capabilities for photocoagula...
Outlook Reports Final Results of Lytenava Trial, Plans BLA Resubmission in Q1-2025
Outlook Therapeutics reported Jan. 16 the final results of the NORSE EIGHT trial of ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD). ONS...
Aurion Plans to Launch IPO; Alcon Loses Court Bid to Stop Move
A judge will allow Aurion Biotech, of Seattle, Washington, to go ahead with its planned initial public offering after rejecting shareholder Alcon’s arguments to prevent the move. The decision was h...
NovaBay Gains Shareholder Approval to Sell Eye Care Business
NovaBay, of Emeryville, California, reported Jan. 23 that it had completed the sale of its eye care business to PRN Physician Recommended Nutriceuticals for $11.5 million. The sale includes all the...
Retrospective Study Finds Link Between IVT Injections, Cataract Surgery Complications
Researchers from the Byers Eye Institute at Stanford Health Care in Palo Alto, California, have found that cataractpatients with prior intravitreal (IVT) injections face more complications after ca...
US FDA Grants Rare Pediatric Designation to MeiraGTx’ LCA1 Gene Therapy Candidate
MeiraGTx, with offices in London and New York, announced Jan. 22 that the US FDA had granted rare pediatric disease designation to its AAV8-RK-RetGC gene therapy candidate for Leber congenital amau...
US FDA Grants Fast Track Status to Nacuity’s Oral RP Candidate
Nacuity Pharmaceuticals announced Jan. 21 that the US FDA had granted fast track designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s oral retinitis pigmentosa (RP) treatment candidat...
Repka Plans to Use AAO Presidency to Push for Medicare Payment Reform
Michael X. Repka, MD, MBA, the new president of the American Academy of Ophthalmology, plans to make Medicare payment reform his top priority during his one-year term. Medicare reimbursement to US ...
Health Canada Approves Rayner’s RayOne EMV Toric IOL
UK-based Rayner announced Jan. 21 that Health Canada had approved the toric version of its RayOne EMV enhanced monofocal intraocular lens (IOL). The non-toric version of the lens was approved in Ca...
Inventors of OCT to be Inducted Into National Inventors Hall of Fame
The inventors of optical coherence tomography continue to be recognized for their groundbreaking work. James G. Fujimoto, PhD (Massachusetts Institute of Technology), David Huang, MD, PhD (Oregon H...
Formycon, Klinge Gain EU Approval for Eylea Biosimilar Under Brand Names Ahzantive and Baiama
German companies Formycon and Klinge Biopharma announced Jan. 20 that the European Commission had granted marketing authorization for their Eylea biosimilar, under the brand names Ahzantive and Bai...
Arctic Vision Gains Approval of Arcatus (Xipere) for Uveitic Macular Edema in Australia, Singapore
Clearside Biomedical announced Jan. 22 that its Asia-Pacific partner, Arctic Vision, had gained approval in Australia and Singapore for Arcatus, known as Xipere in the US, for uveitic macular edema...
Senju Files for Marketing Approval of Dry Eye Candidate SJP-0132 in Japan
Japan’s Senju Pharmaceutical announced Jan. 17 that it had submitted a marketing application in Japan for SJP-0132, a TRPV1 antagonist eye drop candidate targeting dry eye. TRPV1 antagonists have a...
Bausch + Lomb Moves to Acquire Whitecap, InflammX to Expand Clinical Pipeline
Bausch + Lomb recently made moves to acquire two companies that it says will strengthen its expanding pipeline and help address unmet needs in ophthalmology. The company announced Jan. 13 that an a...
Dual Inflammasome Inhibiting Implant Shows Positive Phase I/II Results in GA
Inflammasome Therapeutics reported on Jan. 15 positive topline three-month data from a Phase I/II trial of its K8 dual inflammasome inhibiting implant in geographic atrophy (GA). In the study of fi...
Study Shows Promise for Genetic Base Editing in Stargardt Disease
Researchers from Switzerland’s Institute of Molecular and Clinical Ophthalmology Basel and Beam Therapeutics say they have developed a gene editing therapy that could potentially treat Stargardt di...
Tarsus Will Advance Lotilaner Eyelid Gel for Ocular Rosacea
Tarsus Pharmaceuticals, of Irvine, California, announced Jan. 13 that it would advance TP-04, an ophthalmic gel formulation of lotilaner, targeting ocular rosacea. Tarsus, maker of Xdemvy eye drops...
Bausch + Lomb to Collaborate with Character Bio, City Therapeutics in AMD, GA
Bausch + Lomb recently made deals to collaborate with two companies that it says will bolster its expanding pipeline and help address unmet needs in ophthalmology. Character Biosciences reported on...
Bausch + Lomb Launches EnVista Aspire Monofocal-Plus IOLs in Europe
On Jan. 13, Bausch + Lomb announced the launch of its enVista Aspire intermediate-optimized monofocal and toric intraocular lenses, often referred to as monofocal-plus IOLs, in the EU. The IOLs lau...
Teva Signs Deal to Commercialize Formycon’s Aflibercept Biosimilar Candidate in Israel and Most of Europe
Israel’s Teva Pharmaceuticals announced Jan. 13 that it had entered into a collaboration with German companies Klinge Biopharma and Formycon for the semi-exclusive commercialization of FYB203, Form...
Valo Health Suspends Work on Oral DR Candidate After Phase II Trial Misses Endpoints
Valo Health reported Dec. 31 that OPL-0401, its oral diabetic retinopathy treatment candidate, missed its primary and secondary endpoints of improvement in Diabetic Retinopathy Severity Scale score...
Aviceda Raises $207.5 Million in Upsized Series C Round to Advance GA Candidate
Aviceda Therapeutics announced Jan. 7 that it had raised $207.5 million in an upsized Series C funding round. The Cambridge, Massachusetts, company said proceeds would support an ongoing Phase IIb/...
Eyebright Medical Gains Certification in China for Phakic IOL
China’s Eyebright Medical announced Jan. 7 that its phakic intraocular lens, the Loong Crystal PR, had received certification as a Class III medical device from the country’s National Medical Produ...
Low-Vision Devices, Including One Similar to a Fly’s Eye, Highlighted at CES 2025
The 2025 Consumer Electronics Show featured at least two wearable devices intended to improve vision for those who are vision impaired or legally blind. The conference was held Jan. 7-10 in Las Veg...
US FDA Grants Rare Pediatric Disease Designation to ViGeneron’s RP Gene Therapy Candidate
Germany’s ViGeneron announced Jan. 8 that the US FDA had granted rare pediatric disease designation to VG901, a gene therapy candidate targeting retinitis pigmentosa (RP) caused by mutations in the...
Eyenuk Appoints Gaurav Agarwal as Chief Executive Officer
Digital health care company Eyenuk, of Los Angeles, California, announced Jan. 6 that it had appointed Gaurav Agarwal as chief executive officer. Agarwal was previously the head of product and cust...
Unity Biotechnology Appoints Federico Grossi, MD, PhD, as Chief Medical Officer
Unity Biotechnology announced Jan. 6 that it had appointed Federico Grossi, MD, PhD, as chief medical officer. Grossi was most recently chief medical officer at Apellis Pharmaceuticals, where he he...
Xbrane Resubmits BLA to US FDA for Ranibizumab Biosimilar
Sweden’s Xbrane Biopharma announced Dec. 31 that it had resubmitted the biologics license application (BLA) to the US FDA for its Lucentis (ranibizumab) biosimilar candidate. The FDA issued a compl...
Ophthalmic Revenue Roundup for Carl Zeiss Meditec, Amgen, Biogen
Carl Zeiss Meditec reported Dec. 11 that ophthalmology revenue for its full fiscal year 2023/2024, which ended Sept. 30, was €1.59 billion (US $1.7 billion, converted Dec. 11, 2024), an increase of...
ViGeneron Gains US FDA Green Light to Begin Phase I/II Trial of Gene Therapy Candidate for Stargardt
Germany’s ViGeneron announced Dec. 18 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II study of VG801, a gene therapy candidate to treat Stargardt disease...
EssilorLuxottica to Acquire Espansione Group, Maker of Ophthalmic Devices
Eyewear conglomerate EssilorLuxottica announced Dec. 16 that it had entered into an agreement to acquire Espansione Group, an Italian maker of light-based ophthalmic devices. Financial details and ...
SightStream is Developing an Eye Drop Candidate for Corneal Endothelial Disease
SightStream Biotherapeutics, an ophthalmic drug development company spun out of Harvard University in 2020, is raising $7.5 million in Series A funding to advance its preclinical melanocortin recep...
Children’s Hospital Los Angeles Celebrates 100th Luxturna Procedure
Children’s Hospital Los Angeles (CHLA) marked a milestone recently, completing its 100th procedure with the retinal gene therapy Luxturna for Leber congenital amaurosis (LCA)—the most of any center...
US FDA Grants Rare Pediatric Disease Designation to EyeDNA’s RP Gene Therapy Candidate
France’s eyeDNA Therapeutics announced Dec. 17 that the US FDA had granted rare pediatric disease designation for HORA-PDE6b, its gene therapy candidate for PDE6b-associated retinitis pigmentosa (R...
Carter’s Many Accomplishments Include Saving Millions from Blindness
Former US president Jimmy Carter’s many legacies include saving the of sight of millions of people in less developed regions by providing treatment for onchocerciasis and trachoma through his Carte...
Glaukos Submits NDA for Epioxa Epi-On Crosslinking Treatment
Glaukos, of Aliso Viejo, California, reported Dec. 23 that it had submitted its new drug application to the US FDA for Epioxa, an epi-on version of the company’s iLink corneal crosslinking therapy,...
Alcon Recalls Single Lot of Systane Ultra PF Drops Over Fungal Contamination
The US FDA announced on Dec. 21 that Alcon was voluntarily recalling a single lot of Systane Lubricant Eye Drops Ultra PF over possible fungal contamination. Systane Ultra PF is used for the tempor...
US FDA Gives Green Light to Phase I/II Trial of SpliceBio’s Protein-Splicing Gene Therapy Candidate for Stargardt
Spain’s SpliceBio announced Dec. 12 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II trial of SB-007, a protein-splicing gene therapy candidate for Starga...
Provectus Launches VisiRose to Commercialize Rose Bengal Antimicrobial Light Treatments
Provectus Biopharmaceuticalsannounced Dec. 11 that it had launched VisiRose, a company focused on commercializing rose bengal photodynamic antimicrobial therapy (PDAT) for infectious keratitis and ...
Roche’s Vabysmo Prefilled Syringe Approved in EU for Wet AMD, DME, and RVO
Swiss drugmaker Roche announced Dec. 13 that the European Medicines Agency had approved the Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD), ...
Johns Hopkins Scientists Develop Clear OVD That Glows Under Blue Light
Scientists at Johns Hopkins University have developed a clear ophthalmic viscosurgical device (OVD) that turns fluorescent green under blue light, allowing surgeons to verify complete removal of th...
NIH Joins Push to Fund Breakthroughs in Oculomics
The National Institutes of Health (NIH) is joining the push to fund the development of technologies and biomarkers to diagnose systemic disease through the eye, a field known as oculomics. The NIH ...
$2.3 Million NIH Grant Furthers U. of Oklahoma Research into Retinopathy of Prematurity
A University of Oklahoma neonatologist has earned a five-year, $2.3 million grant from the National Institutes of Health (NIH) to further her studies on retinopathy of prematurity (ROP). Faizah Bha...
Scripps Research Includes AMD Among its Regenerative Medicine Targets
Scientists at Scripps Research and its nonprofit drug development arm, the Calibr-Skaggs Institute for Innovative Medicines, are advancing novel regenerative medicines capable of repairing tissues ...
500 Thousand Arizona Students Get Vision Screening Thanks to New Law
Vision health advocacy group Eyes on Learning reported Nov. 14 that around 500 thousand schoolchildren in Arizona are receiving vision screening this year thanks to a new state law and help from lo...
Visus Merges with Tenpoint, Will Advance Brimochol Once-Daily Presbyopia Drop Candidate
Visus Therapeutics and Tenpoint Therapeutics announced Dec. 12 the completion of a merger, with plans to advance Visus’ Brimochol PF, a once-daily eye drop candidate for presbyopia. The combined co...
Acelyrin’s Izokibep Misses Endpoints in Phase IIb/III Uveitis Trial
Acelyrin reported Dec. 10 that izokibep, an inhibitor of interleukin-17A, missed its endpoints in a Phase IIb/III trial in non-infectious, non-anterior uveitis. The company said it would drop izoki...
NurExone Reports Promising Preclinical Results in Restoring Vision After Optic Nerve Damage
NurExone Biologic, with offices in Canada and Israel, reported Dec. 6 findings of a preclinical study of its lead candidate, ExoPTEN, for repairing optic nerve damage. Researchers utilized a rodent...
Aflibercept Biosimilar Candidate from Celltrion Gains Positive CHMP Opinion
South Korea’s Celltrion announced Dec. 15 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued positive opinions recommending approval of three of i...
ViaLase Teams up with Moran Eye Center to Enhance Femto Laser Glaucoma Procedure
ViaLase of Aliso Viejo, California, reported Dec. 10 that it would partner with the John A. Moran Eye Center at the University of Utah to explore the effect of creating multiple channels in the tra...
SIFI Files for UK Approval of Akantior Drops for Acanthamoeba Keratitis
Italy’s SIFI reported Dec. 16 that it had filed a marketing authorization application with the UK’s Medicines and Healthcare Products Regulatory Agency for Akantior (polihexanide 0.08%) drops for t...
Nidek Launches NP-T Preloaded Toric IOL Injector Globally
Japanese ophthalmic company Nidek announced Dec. 2 that it had launched the NP-T preloaded toric intraocular lens (IOL) injection system globally. Previously, the injector had been available only i...
Nicox Reports First Sale of Zerviate in China by Partner Ocumension
France’s Nicox reported Dec. 4 that its partner Ocumension Therapeutics had made the first commercial sale of Zerviate (cetirizine ophthalmic solution) 0.24% in China. Zerviate is indicated for ocu...
Bausch + Lomb Acquires Elios Vision, Developer of Excimer Laser Trabeculostomy
Bausch + Lomb announced Dec. 11 that an affiliate had acquired Elios Vision, developer of the Elios excimer laser trabeculostomy procedure for glaucoma. No financial details were disclosed. Elios’ ...
Topcon Weighing Takeover Bids from Private Equity Firms, Bloomberg Reports
Topcon is considering takeover bids from suitors, including the private equity firms KKR & Co. and EQT AB, according to a report Dec. 10 from financial news outlet Bloomberg. The Tokyo-based ophtha...
ARPA-H Pledges $125 Million in Quest to Advance Whole Eye Transplants
The Advanced Research Projects Agency for Health (ARPA-H) announced Dec. 2 that it would pledge up to $125 million from its Transplantation of Human Eye Allografts (THEA) program to advance researc...
Zeiss Gains US Approval for MEL 90 Excimer Laser
Carl Zeiss Meditec gained US FDA approval on Dec. 4 for its MEL 90 excimer laser, the next-generation iteration of its MEL 80 for LASIK surgery. The MEL 90’s US labeling is for correction of myopia...
US FDA Gives Green Light to Phase I/II Trial of Sumitomo Retinal Cell Implant for RP
Japan’s Sumitomo Pharma announced Nov. 29 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II trial of its allogeneic retinal sheet derived from induced plur...
US FDA Grants Orphan Drug Status to AAVantgarde Bio’s Gene Therapy Candidate for Usher1B RP
Italy’s AAVantgarde Bio announced Dec. 2 the US FDA had granted orphan drug designation to its lead gene therapy candidate, AAVB-081, targeting Usher syndrome type 1B retinitis pigmentosa. Orphan d...
Medvisis to Market Clobetasol Drops in Switzerland, Liechtenstein, Under License with Formosa
Swiss company Medvisis has obtained exclusive rights to market clobetasol propionate eye drops in Switzerland and Liechtenstein for inflammation and pain following ocular surgery under a license ag...
Kyung-Ah Kim, PhD, Named President, CEO of Samsung Bioepis
South Korea’s Samsung Bioepis announced Nov. 27 that Kyung-Ah Kim, PhD, has been appointed president and chief executive officer. Kim had been serving as executive vice president and development di...
Ophtec Receives CE Marking for Artiplus Phakic IOL, Targets Young Presbyopes
Dutch company Ophtec announced Nov. 18 that it had gained CE Mark approval for its Artiplus phakic intraocular lens (IOL). The company said the lens offered a solution for relatively young presbyop...
Outlook’s Lytenava Misses Endpoint vs. Ranibizumab in Topline Results
Outlook Therapeutics reported Nov. 27 that its ophthalmic bevacizumab candidate Lytenava (ONS-5010) did not meet its non-inferiority endpoint in topline results from the NORSE EIGHT trial vs. ranib...
US FDA Rejects sNDA for Izervay Seeking Every-Other-Month Dosing
Japan’s Astellas Pharma announced Nov. 19 that the US FDA had issued a complete response letter rejecting its supplemental new drug application (sNDA) for Izervay seeking to expand the drug’s label...
Konan Medical Launches ObjectiveField Perimeter in US
Konan Medical has launched its ObjectiveField visual field analyzer in the US. The ObjectiveField is an objective perimeter designed to detect visual field abnormalities using pupillary responses. ...
EU Grants Orphan Drug Status to Ocugen’s Gene Therapy Candidate for ABCA4-Associated Retinopathies
Ocugen announced Nov. 20 that the European Medicines Agency had granted orphan medicinal product status for OCU410ST, a gene therapy candidate targeting ABCA4-associated retinopathies, including St...
Avant, Ainnova Advancing Low-Cost Retinal Camera with AI Screening Software
Nevada-based Avant Technologies and Ainnova Tech, of Houston, Texas, announced Nov. 20 that the two companies would advance Ainnova’s proprietary low-cost retinal camera packaged with the Vision AI...
MACs Finalize Coverage for Standalone and Combo MIGS Procedures
Five Medicare administrative contractors have issued their final coverage policies for minimally invasive glaucoma surgery, or MIGS, along with more technical billing and coding documents. The poli...
Harrow Lowers Price of Drugs through GoodRx Partnership, Price Cuts
Harrow, of Nashville, Tennessee reported Nov. 13 that it had entered into a partnership with GoodRx to provide patients for whom insurance is not a viable option a cash-pay alternative. Harrow prod...
GenSight Submits Updated Data on Lumevoq to Restart Early Access Program in France
Paris-based GenSight Biologics announced Nov. 13 that it had submitted an updated regulatory file for Lumevoq, its gene therapy candidate for Leber hereditary optic neuropathy (LHON), to French reg...
US FDA Clears Tixel i Dry Eye and MGD Treatment Device from Novoxel
Israel’s Novoxel announced Nov. 19 that the US FDA had granted 510(k) clearance to the Tixel i treatment device for evaporative dry eye and meibomian gland dysfunction. The company said the device ...
Nicox Chooses Higher Dose of NCX 470 to Advance in Phase III Glaucoma Trials
France’s Nicox announced Nov. 19 that it had chosen the higher dose of NCX 470 ophthalmic solution to advance in the Phase III Mont Blanc trial in glaucoma. The company said both doses tested—0.065...
Atsena Licenses LCA1 Gene Therapy Candidate to Nippon Shinyaku for US, Japan
Atsena Therapeutics announced Nov. 13 that it had granted exclusive commercial rights for its Leber congenital amaurosis type 1 (LCA1) gene therapy candidate ATSN-101 to Nippon Shinyaku in the US a...
US FDA Grants Rare Pediatric, Fast Track Status to Alkeus’ Stargardt Candidate
Alkeus Pharmaceuticals announced Nov. 18 that the US FDA had granted rare pediatric disease and fast track designations to gildeuretinol (ALK-001), its oral therapy candidate for Stargardt disease....
CMS Cuts Ophthalmologists’ Procedure Fees, While Raising ASC, HOPD Facility Fees
The Centers for Medicare and Medicaid Services (CMS) published on Nov. 1 the final schedule of Medicare reimbursement fees for physicians in 2025. It also released its facility fee payments for ASC...
Amgen Launches Eylea Biosimilar Pavblu After Court Win Over Regeneron
Amgen has launched its Eylea biosimilar, Pavblu (aflibercept-ayyh), after a victory in October in its patent fight with Regeneron. Fierce Pharma reported that a trio of US circuit judges on Oct. 22...
Harrow’s ImprimisRx Unit Gets $34.9 Million Trademark Infringement Verdict
Harrow’s ImprimisRx subsidiary received a $34.9 million verdict on Nov. 20, 2024, in a trademark infringement lawsuit against OSRX Pharmaceuticals, of Missoula, Montana. OSRX is an affiliate of Ocu...
Q3-2024 Ophthalmic Revenue Roundup for Immunocore, Harrow, Tarsus, Lumibird, and Ocular Therapeutix
UK-headquartered Immunocore reported Nov. 6 that its Q3-2024 net revenue from Kimmtrak (tebentafusp) was $80.2 million, a 28 percent increase over $62.6 million in Q3-2023. Regionally, Kimmtrak net...
Samsung Bioepis, Biogen Gain EU Approval for Aflibercept Biosimilar Known as Opuviz
Korea’s Samsung Bioepis and Biogen, of Cambridge, Massachusetts, announced Nov. 18 that the European Commission had granted marketing authorization for Opuviz (aflibercept-yszy), an Eylea biosimila...
US FDA Accepts NDA for Aldeyra’s Reproxalap in Dry Eye
Aldeyra Therapeutics announced Nov. 18 that the US FDA had accepted for review the company’s resubmitted new drug application (NDA) for topical ocular reproxalap for dry eye. The FDA assigned a Pre...
MeiraGTx to Submit UK Marketing Application for LCA4 Candidate Under ‘Exceptional Circumstances’
MeiraGTx, with offices in London and New York, announced Nov. 13 that it would submit a marketing authorization application in the UK under “exceptional circumstances” for AAV-AIPL1, its gene thera...
Eyenovia Scraps Phase III Study of Low-Dose Atropine in Myopia After Endpoint Missed
Eyenovia reported Nov. 15 that it would scrap the Phase III CHAPERONE trial of low-dose atropine in pediatric myopia after an independent data review committee determined that the trial is not meet...
Sandoz Gains EU Approval for its Aflibercept Biosimilar Known as Afqlir
Swiss drugmakerSandoz announced Nov. 15 that the European Commission had granted marketing authorization for Afqlir (aflibercept), an Eylea biosimilar. Afqlir, available as a 2 mg vial kit and pre-...
Q3-2024 Ophthalmic Revenue Roundup for Alcon, Hoya, RxSight, Sight Sciences, and Iridex
Alcon reported Nov. 12 that its Q3-2024 net sales totaled $2.4 billion, a 6 percent increase over $2.3 billion in Q3-2023. Surgical net sales for implantables, consumables, and equipment/other were...
Kalaris Will Merge with AlloVir and Advance Candidate for Exudative Retinal Disease
Kalaris Therapeutics announced Nov. 8 that it would merge with biotech company AlloVir in an all-stock transaction to advance Kalaris’ next-generation anti-VEGF candidate TH103 for exudative retina...
Advancium Signs Option to License Retinoblastoma Candidate from Aileron
Aileron Therapeutics and Advancium Health Network announced Oct. 31 an exclusive option agreement for Advancium to acquire ALRN-6924, a clinical-stage oncology agent developed by Aileron prior to i...
Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million
Clearside Biomedical’s Asia-Pacific partner, Arctic Vision, announced Nov. 7 that it had licensed Chinese commercialization rights for ARVN001, marketed in the US as Xipere, to Santen Pharmaceutica...
US FDA Grants Fast Track Designation to Feliqs’ ROP Candidate
Japanese biopharmaceutical company Feliqs announced Nov. 1 that the US FDA had granted its lead asset, FLQ-101, fast track designation for the prevention of retinopathy of prematurity (ROP). FLQ-10...
US FDA Grants De Novo Classification to LumiThera’s Photobiomodulation System for Dry AMD
LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobiomodulation system for treatment of patients with dry age-related macul...
Q3-2024 Ophthalmic Revenue Roundup for AbbVie, Apellis, Glaukos, STAAR, and Lensar
AbbVie, of North Chicago, Illinois, reported Oct. 30 that its Q3-2024 eye care net revenue was $525 million, a 13.5 percent decline (-11.2 percent cc) from $605 million in Q3-2023. Restasis revenue...
NovaBay Accepts Higher Offer from PRN to Purchase Assets
NovaBay reported Nov. 6 that it had accepted a higher offer from PRN Physician Recommended Nutriceuticals, LLC, which revised its bid for NovaBay’s Avenova product line after a competing overture f...
US FDA Asks for Added Data on Neurotech MacTel Candidate, Pushes Back PDUFA Date
Neurotech Pharmaceuticals announced Nov. 8 that it had submitted additional data requested by the US FDA to support its biologic license application (BLA) for NT-501, an encapsulated cell therapy i...
US FDA Gives Green Light to Phase I Trial of HuidaGene’s CRISPR RNA-Editing Candidate for Wet AMD
HuidaGene Therapeutics announced Nov. 4 that the US FDA had cleared its investigational new drug (IND) application for a Phase I trial of HG202, a gene therapy candidate targeting wet age-related m...
DÁVI Licenses Clobetasol Propionate Post-op Drops from Formosa for Portugal
Taiwan-based Formosa Pharmaceuticals announced Oct. 31 that it had entered into an exclusive licensing agreement with DÁVI Farmacêutica, of Portugal, for the rights there to market clobetasol propi...
Tarsus Appoints Elizabeth Yeu, MD, as Chief Medical Officer
Tarsus Pharmaceuticals, maker of Xdemvy for Demodex blepharitis, announced Nov. 5 that it had appointed Elizabeth Yeu, MD, as chief medical officer. Yeu had served as Tarsus’ chief medical advisor ...
Astellas Withdraws EU Marketing Application for Avacincaptad Pegol in GA
Japan’s Astellas Pharma announced Oct. 28 that it had withdrawn its marketing authorization application in the EU for avacincaptad pegol, a complement-5 inhibitor targeting geographic atrophy (GA) ...
Q3-2024 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Novartis
Regeneron of Tarrytown, New York, reported Oct. 31 that its Q3-2024 US revenue for Eylea (aflibercept) 2 mg and Eylea HD (a higher dose of aflibercept at 8 mg) was $1.54 billion, a 3 percent increa...
Vabysmo Improved Vision in Underrepresented Populations with DME in Elevatum Study
Genentech, a member of the Roche Group, announced Oct. 18 positive topline one-year results from the postmarket Elevatum study evaluating Vabysmo (faricimab-svoa) for the treatment of diabetic macu...
Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH
Michelle E. Tarver, MD, PhD, has been named director of the FDA’s Center for Devices and Radiological Health (CDRH), after serving as acting director since July 2024. She is a board-certified ophth...
NovaBay Receives Higher Asset Purchase Bid from RVL-Affiliated Company
NovaBay reported Oct. 29 that it had received a better offer for its assets than the one it had accepted from PRN Physician Recommended Nutriceuticals, LLC. NovaBay’s board determined that the unso...
Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III
Alkeus Pharmaceuticals reported positive topline results on Oct. 23 from the Phase III SAGA trial of gildeuretinol acetate (ALK-001), a once-daily oral therapy candidate targeting geographic atroph...
RevOpsis Awarded $1.8 Million NEI Grant to Advance Retinal Candidate RO-104
RevOpsis Therapeutics announced Oct. 15 that it had been awarded a Small Business Innovation Research grant of $1.8 million from the National Eye Institute (NEI) to advance lead asset RO-104 for ex...
Korean Companies GC Biopharma, Novelty Nobility to Collaborate on GA Drug Discovery
South Korean companies GC Biopharma and Novelty Nobility announced Oct. 28 that they would jointly research and develop a novel treatment candidate for geographic atrophy (GA). The companies said a...
Pine Pharmaceuticals Stops Compounding IVT Avastin, Creating Concerns Over Shortage
Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...
Q3-2024 Ophthalmic Revenue Roundup for Roche and J&J Vision
Swiss company Roche reported Oct. 23 that Q3-2024 Vabysmo sales were CHF 1 billion ($1.15 billion, converted on Oct. 23, 2024), a 59 percent increase over CHF 656 million in Q3-2023. The company sa...
US FDA Accepts NDA For Lenz’ Presbyopia Drop Candidate
Lenz Therapeutics announced Oct. 21 that the US FDA had accepted its new drug application (NDA) for LNZ100, a once-daily, preservative-free eye drop candidate for presbyopia. The FDA assigned a Pre...
Ocuphire Pharma Acquires Opus Genetics, Will Operate Under Opus Name
Ocuphire Pharma announced Oct. 22 that it would acquire Opus Genetics in an all-stock transaction. The combined company will operate under the Opus name and will trade on the Nasdaq under the ticke...
ARPA-H Seeks Proposals for Tear Duct-Based Diagnostic System, Plus Custom Dosing Platform
ARPA-H announced Oct. 18 that it had launched a new program to develop a tear-based biomarker measurement system that can be inserted into the tear duct to provide continuous health monitoring, pai...
Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients
Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...
Grifols, BARDA Partner on Ocular Immunoglobulin Drops for Sulfur Mustard Exposure
Barcelona-basedGrifols reported Oct. 22 that it is partnering with the US government’s BARDA to test ocular surface immunoglobulin (OSIG) eye drops for their ability to treat ocular damage from sul...
Corza Launches Onatec Ophthalmic Microsurgical Suture Portfolio
Corza Medical, of Westwood, Massachusetts, reported Oct. 21 that it had launched its Onatec ophthalmic microsurgical suture portfolio of needles and suture material. The company said Onatec needles...
Bausch + Lomb Gains US FDA Approval of enVista Envy Trifocal IOL
Bausch + Lomb reported Oct. 14 that the US FDA had approved itsenVista Envy trifocal intraocular lens. The lens is available on a limited basis in the US and will be launched more broadly in 2025. ...
Spinogenix Unveils Glaucoma Program to Evaluate Once-Daily Neuroprotective Pill
Los Angeles-based Spinogenix reported Oct. 16 that it was launching a program to evaluate SPG302 as a potential neuroprotective therapeutic for glaucoma. Spinogenix describes SPG302 as a once-a-day...
Eyenuk, AAO Collaborate to Offer AI-Driven DR Screening for Underserved Patients in Delaware
Eyenuk and the American Academy of Ophthalmology (AAO) reported Oct. 16 that they had teamed up under the AAO’s EyeCare America program to provide eye disease screening for underserved communities ...
US FDA Grants 510(k) Clearance to Flex Module for Heidelberg Spectralis OCT
Heidelberg Engineering announced Oct. 14 that the US FDA had granted 510(k) clearance to its Flex Module for the Spectralis diagnostic imaging platform. The Flex Module mounts the Spectralis to a m...
Orasis Licenses Qlosi Presbyopia Drops to Optus in Korea for $18 Million, Plus Royalties
Orasis Pharmaceuticals announced Oct. 16 that it had licensed its Qlosi presbyopia drops to Optus Pharmaceuticals for the Korean market. Under the deal, Optus will pay upfront and milestone payment...
Nicox and Soleus Sign $16.5 Million Deal for Vyzulta Royalties, Equity Financing
France’s Nicox announced Oct. 14 a deal with Soleus Capital under which Soleus will acquire Nicox’ royalties from the glaucoma treatment Vyzulta for $15 million, while providing $1.5 million in equ...
Cure Blindness Project Expands Sight-Saving Care to Six New Countries
Cure Blindness Project is expanding to six new countries—Burundi, Democratic Republic of the Congo, Liberia, Pakistan, Paraguay, and Zambia, the charity reported Oct. 10. Paraguay marksthe charity’...
Lensar Marks 1 Million Procedures Using its Femtosecond Cataract Lasers
Lensar reported Oct. 8 that surgeons had performed more than 1 million procedures using its Lensar femtosecond cataract systems. The Orlando, Florida, company introduced its original Lensar Laser S...
EU Grants Orphan Drug Status to Theriva’s Retinoblastoma Candidate
Theriva Biologics, of Rockville, Maryland, announced Oct. 16 that the European Commission had granted orphan medicinal product designation for VCN-01, its treatment candidate for retinoblastoma. VC...
Aldeyra Resubmits NDA for Reproxalap in Dry Eye
Aldeyra Therapeutics announced Oct. 3 that it had resubmitted its new drug application (NDA) to the US FDA for topical ocular reproxalap in dry eye. The US FDA issued a complete response letter in ...
Nanoscope Plans to Submit BLA for Optogenetic RP Candidate in Q1-2025
Nanoscope Therapeutics announced Oct. 10 that it had met with the US FDA regarding MCO-010, an ambient-light-activatable optogenetic monotherapy to restore vision in patients with advanced retiniti...
Want to Read the Full Article?
Already Have an Account?
Register A Corporate Account
A corporate account gives you access to licensed reports and subscriptions, the latest news, a personalized dashboard, and weekly emails with news and data.