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
Alcon Agrees to Acquire STAAR Surgical in Deal Worth $1.5 Billion
—STAAR’s Evo ICL fills a strategic gap in Alcon’s surgical portfolio, broadening its refractive product line while bolstering STAAR’s global commercialization. The Deal: Alcon will acquire STAAR Su...
US FDA Approves Lenz’ Vizz (Aceclidine) Drops for Presbyopia
Lenz Therapeutics announced July 31 that the US FDA had approved Vizz (aceclidine ophthalmic solution) 1.44% for presbyopia. The company said Vizz was the first once-daily, preservative-free eye dr...
Q2-2025 Ophthalmic Revenue Roundup for Roche, Bausch + Lomb, Apellis, Glaukos, and Astellas
Swiss company Roche reported July 24 that Vabysmo sales for Q2-2025 were CHF 1.05 billion ($1.3 billion, converted June 30, 2025), a 19 percent increase over CHF 947 million in Q2-2024. Roche said ...
CMS Proposes Lower Physician Payments in 2026, Higher HOPD and ASC Fees
US ophthalmologists are gaining some clarity on what their reimbursement for treating Medicare patients may look like in 2026. Documents published by the Centers for Medicare and Medicaid Services ...
Boehringer Ingelheim and Re-Vana Sign Potential $1 Billion Collaboration Deal
Boehringer Ingelheim and Re-Vana Therapeutics will collaborate to develop extended-release therapies for eye diseases in a deal worth potentially more than $1 billion for Re-Vana, the companies ann...
Alcon Launches Tryptyr (Acoltremon) Drops for Dry Eye in US
Alcon announced July 29 the US commercial availability of Tryptyr (acoltremon ophthalmic solution) 0.003% to treat the signs and symptoms of dry eye. Tryptyr is a first-in-class TRPM8 agonist, dose...
New Minnesota Law Expands ODs’ Authority to Prescribe Drugs, Perform Injections
A new law passed in Minnesota expands optometrists’ authority to prescribe certain medications and allows them to administer some in-office injections. The Minnesota Optometric Association (MOA) ha...
Innovia Medical Acquires Ophthalmic Surgical Instrument Maker Hurricane Medical
Innovia Medical, of St. Paul, Minnesota, reported July 2 that it had acquired Bradenton, Florida-based Hurricane Medical, manufacturer of ophthalmic surgical instruments, as well as Memphis, Tennes...
Glaukos Acquires Mobius Therapeutics and its Mitosol Antifibrotic Agent
Glaukos announced during its earnings call on July 30 that it had acquired Mobius Therapeutics, of St. Louis, Missouri, whose lead compound, Mitosol, is the only FDA approved ophthalmic formulation...
Aflibercept Biosimilar Candidate from Alteogen Gains Positive CHMP Opinion
South Korea’s Alteogen announced July 28 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended approval for Eyluxvi (ALT-L9), its proposed biosi...
UM Whole Eye Transplant Project Overcomes Two Hurdles
Two critical pieces needed to eventually transplant a whole eye have been created and tested successfully at the University of Miami, the school reported July 24. Seventeen UM faculty members are w...
Exonate Plans Phase IIb Trial of Retinal Eye Drop Candidate in NPDR
British company Exonate announced July 29 that it planned a Phase IIb clinical trial for lead compound EXN407, an eye drop candidate targeting retinal vascular diseases, in patients with non-prolif...
Unity Board Dissolves Company, Ending Research Targeting Senescent Cells
Unity Biotechnology’s board agreed on June 27 to dissolve the South San Francisco, California, company after evaluating strategic alternatives. The Nasdaq delisted Unity’s stock on July 9. Both mov...
Santen Launches Ryjunea Drops in Germany for Pediatric Myopia
Japan’s Santen Pharmaceutical announced July 22 that it had launched Ryjunea low-dose atropine eye drops in Germany for pediatric myopia. Germany is the first market for Ryjunea, which received EU ...
George Tidmarsh, MD, PhD, Named to Lead FDA’s Center for Drug Evaluation and Research
The US FDA reported July 21 that George Tidmarsh, MD, PhD, had been named director of the Center for Drug Evaluation and Research. Tidmarsh, a Stanford University faculty member and physician scien...
First Patient Treated in US Trial of Eyetronic Optic Nerve Therapy for Glaucoma
The Glaucoma Center of San Francisco announced July 21 that it had treated the first patient in the US as part of a clinical trial of Eyetronic, a non-invasive therapy to stimulate the optic nerve....
Viatris’ Phase III Blepharitis Ointment Candidate Fails to Reach Primary Endpoint
Viatris announced July 18 that a Phase III trial of pimecrolimus 0.3% (MR-139) ophthalmic ointment in blepharitis did not meet its primary endpoint of complete resolution of debris after six weeks ...
Bioeq Licenses Lucentis Biosimilar to Bio Usawa for Sub-Saharan Africa
Swiss company Bioeq announced July 1 that it had licensed its Lucentis (ranibizumab) biosimilar to African biotech company Bio Usawa for marketing in sub-Saharan Africa under the brand name BioUcen...
Regulators in Canada Approve Xipere for Uveitic Macular Edema
Clearside Biomedical announced July 23 that Health Canada had approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use in uveitic macular edema. Bausch + Lomb has lice...
Novartis Reports Q2-2025 Lucentis Revenue of $173 Million
Novartis reported July 17 that its Q2-2025 Lucentis revenue outside the US was $173 million, a 37 percent decline (-39 percent cc) from $275 million in Q2-2024. The Swiss company said sales decline...
Onconetix to Merge with Glaucoma Drop Maker Ocuvex
Onconetix, of Cincinnati, Ohio, announced July 16 a definitive merger agreement with Ocuvex, maker of Omlonti (omidenepag isopropyl 0.002%) drops for glaucoma. The combined company will carry the O...
Beacon Licenses Abeona’s AAV204 Capsid for Select Ophthalmic Indications
Beacon Therapeutics has exercised its option to license Abeona Therapeutics’ AAV204 capsid for potential gene therapies for select ophthalmic indications, the companies announced July 1. Under the ...
US FDA Grants Fast Track Status to Sanofi’s GA Gene Therapy Candidate
France’s Sanofi announced July 16 that the US FDA had granted fast track designation to SAR446597, its gene therapy candidate for geographic atrophy (GA). SAR446597, designed for one-time intravitr...
Outlook Therapeutics Appoints Bob Jahr as CEO
Outlook Therapeutics announced July 1 that it had appointed Bob Jahr as chief executive officer. Jahr will also take a seat on Outlook’s board, the company said. Lawrence A. Kenyon, who had served ...
Glaucoma Laser Company ViaLase Appoints Shawn O’Neil as CEO
ViaLase announced July 8 that it had appointed Shawn O’Neil, formerly the company’s chief commercial officer, as chief executive officer. Company founder Tibor Juhasz, PhD, transitioned from CEO to...
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.
Harrow Secures US Rights to Retinal Biosimilars Byooviz and Opuviz
Harrow announced July 17 that it had secured exclusive US commercial rights to Samsung Bioepis’ FDA-approved ophthalmology biosimilars—Byooviz (ranibizumab-nuna) and Opuviz (aflibercept-yszy). No f...
J&J Vision Generates Q2-2025 Surgical Revenue of $403 Million
J&J Vision’s Q2-2025 global surgical revenue totaled $403 million, a 9.9 percent increase (+8.9 percent cc) over $367 million in Q2-2024, parent Johnson & Johnson, of New Brunswick, New Jersey, rep...
Clearside Explores Strategic Alternatives, Transitions Workforce
Clearside Biomedical reported July 17 that it was exploring strategic alternatives to continue advancing its suprachoroidal space delivery platform and ophthalmic pipeline, while transitioning all ...
Kowa Licenses Nicox’ Glaucoma Drop for US, Other Territories in $222 Million Deal
France’s Nicox announced July 17 that Japan’s Kowa had licensed its glaucoma candidate, NCX 470 (0.1% bimatoprost), for the US and all other unlicensed territories in a deal worth up to €191.5 mill...
Nanoscope Initiates Rolling BLA Submission for Optogenetic RP Candidate
Nanoscope Therapeutics announced July 14 that it had initiated a rolling biologics license application (BLA) submission to the US FDA for MCO-010, an ambient-light-activatable optogenetic monothera...
EyeDura and its Eye Drop Platform Continue to Win Honors from Accelerators
EyeDura Therapeutics reported July 15 that the company had earned the Judges’ Choice and People’s Choice awards at the Octane Ophthalmology Tech Forum, held June 27 in Newport Beach, California. Th...
Israel’s PainReform Enters Ophthalmology with Investment in LayerBio
Israel’s PainReform announced July 10 that it had signed a strategic agreement with LayerBio, which is developing OcuRing-K, a sustained-release intraocular implant designed to deliver anti-inflamm...
Ocumetics Begins First-in-Human Study of its Accommodating IOL
Ocumetics Technology, of Calgary, Canada, announced June 24 that it was set to begin a first-in-human clinical study of its accommodating intraocular lens (IOL). The company said all the lenses for...
US FDA Gives Green Light to Trial of AAVantgarde’s Stargardt Gene Therapy Candidate
Italy’s AAVantgarde Bio announced July 15 that the US FDA had cleared the investigational new drug (IND) application for AAVB-039, its gene therapy candidate for Stargardt disease. The company said...
Alcon to Acquire LumiThera and Its Photobiomodulation Device for Dry AMD
Alcon announced July 7 that it intended to acquire LumiThera and its photobiomodulation (PBM) device that targets early and intermediate dry age-related macular degeneration (AMD). No financial det...
Chinese Regulators Approve Perfluorohexyloctane Drops for Dry Eye with MGD
China’s Hengrui Pharmaceuticals and Germany’s Novaliq announced July 8 that China’s National Medical Products Administration had approved Heng Qin (perfluorohexyloctane eye drops) for dry eye assoc...
Rain Eye Drops Launches Dispensing Tool for Single-Use Vials to its Customers
Rain Eye Drops, of Las Vegas, Nevada, reported July 8 the launch of its RainDrop Dispenser Aid, a tool designed to help users apply eye drops from single-use vials more easily and accurately. The c...
RxSight Lowers 2025 Guidance Due to Q2-2025 Preliminary Results
RxSight reported July 8 that it was lowering its 2025 revenue guidance to $120 million to $130 million, down from the range of $185.0 million to $197.0 million provided on Feb. 25, 2025. The Aliso ...
EU Regulators Approve Extended Six-Month Treatment Interval for Eylea 8 mg
German drugmaker Bayer announced June 27 that European regulators had granted a label extension for Eylea (aflibercept) 8 mg with extended treatment intervals of up to six months in wet age-related...
Lenz Licenses Presbyopia Drop Candidate to Théa for Canada in $70 Million Deal
Lenz Therapeutics announced July 7 that France’s Laboratoires Théa had licensed exclusive rights to market LNZ100 (1.75% aceclidine) for presbyopia in Canada. Lenz will receive more than $70 millio...
Alcon Unity VCS Dual-Function System Gains Approval in Canada
Alcon announced July 8 that its dual-function Unity Vitreoretinal Cataract System (VCS) had gained market approval from Health Canada. Commercial launch in Canada is expected in early 2026, the com...
Biocon Gains Approval in Canada for Yesafili, a Biosimilar to Eylea
India’s Biocon Biologics announced June 27 that Health Canada regulators had approved Yesafili, an aflibercept (Eylea) biosimilar, for wet age-related macular degeneration, macular edema secondary ...
Aflibercept Biosimilar Candidate from Alvotech Gains Positive CHMP Opinion
Alvotech and partner Advanz Pharma announced June 23 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended approval for AVT06, Alvotech’s propos...
Iridex Reports Start of UK Trial Using MicroPulse with Anti-VEGF Injections in DME
Iridex reported June 24 that an independent, investigator-led UK study evaluating MicroPulse technology as an adjunct to anti-VEGF therapy in diabetic macular edema (DME) had enrolled its first pat...
CMS to Increase Audits of Medicare Advantage Billing to Prevent Upcoding
Private insurers that take part in the US Medicare Advantage program will see enhanced and accelerated audits of their billing practices under an aggressive new plan, the Centers for Medicare and M...
OpRegen’s Phase I/IIa Trial in GA Shows Mean Improvement in VA Through 36 Months
Lineage Cell Therapeutics reported on June 23 that patients with geographic atrophy who were treated with OpRegen cell therapy in a Phase I/IIa clinical study showed mean improvement in visual acui...
Ophthalmology Tops US Specialties for Percentage of Doctors in Private Practice
Ophthalmology had the highest share of physicians in private practice—70.4 percent—among all US specialties in 2024, according to a Physician Practice Benchmark Survey conducted every other year by...
Hoya Vision Care Acquires Canada’s Centennial Optical
Hoya Vision Care announced June 2 that it had acquired Centennial Optical, a Canadian distributor of ophthalmic frames, eyeglass lenses, sunglasses, lab supplies, and optical accessories. Financial...
Donor Gives $40M to Ophthalmology Department at CU Anschutz in Colorado
An anonymous donor has given a $40 million gift for eye research to the Department of Ophthalmology at the University of Colorado (CU) AnschutzMedical Campus in Aurora, Colorado, the school announc...
Children’s Hospital Los Angeles Receives $12M Gift to Expand Cell, Gene Therapies
Children’s Hospital Los Angeles reported May 21 that it had received a $12 million gift from Alfred E. Mann Charities to establish a cell and gene therapy research endowment and a shorter-term fund...
Uni-Bio Gains Approval in China for Diquafosol Sodium Eye Drops for Dry Eye
Hong Kong-based Uni-Bio Science reported May 21 that it had obtained marketing approval fromthe China National Medical Products Administration for its diquafosol sodium eye drops. Diquafosol sodium...
Health Insurers Pledge to Reform Prior Authorization by 2026
Major insurers of nearly 50 US health plans published a pledge on June 24 to simplify and reduce prior authorization of medical treatments, cutting the volume of treatments subject to such oversigh...
Glaukos Gains EU MDR Certification for Devices in iStent Platform
Glaukos, of Aliso Viejo, California, reported June 25 that it had received European Union (EU) Medical Device Regulation (MDR) certification for devices in its minimally invasive glaucoma surgery (...
Alcon Unity Cataract and Dual-Function Systems Gain Approval in Brazil
Alcon announced June 12 that its dual-function Unity Vitreoretinal Cataract System (VCS) and stand-alone Unity Cataract System (CS) had gained market approval from the Brazilian Health Regulatory A...
Presbyopia Drop Candidate from Viatris and Opus Meets Endpoints in Second Phase III Trial
Commercial partners Viatris and Opus Genetics reported June 26 that their presbyopia drop candidate, MR-141 (phentolamine ophthalmic solution 0.75%), met its primary endpoint and key secondary endp...
PolyActiva Names New CEO, Raises $25 Million to Advance Sustained-Release Glaucoma Implant
Australian company PolyActiva announced June 18 that it had appointed ophthalmic industry veteran Jerry St. Peter as chief executive officer. The company also closed a $25 million Series C funding ...
US FDA Gives Green Light to Phase III Trial of Zhaoke’s Cyclosporine Ophthalmic Gel
Hong Kong’s Zhaoke Ophthalmology announced June 4 that the US FDA had cleared the investigational new drug (IND) application for its 0.05% cyclosporine ophthalmic gel, targeting moderate to severe ...
Zilia Gains Approval in Canada for its Fundus Camera With Ocular Oximetry
Quebec-based device maker Ziliareported June 19 that its Zilia Ocular device, a fundus camera that enables ocular oximetry, had gained approval from Health Canada. The company said it plans to laun...
Amneal Gains US FDA Approval for Generic Prednisolone Acetate Eye Drop
Amneal Pharmaceuticals announced June 12 that it had received US FDA approval for its generic prednisolone acetate ophthalmic suspension, 1%, which references AbbVie’s Pred Forte. The sterile, topi...
VivaVision, US FDA Agree on Accelerated Path for Post-op Inflammation Candidate
VivaVision, of Wenzhou, China, announced June 9 that the US FDA had agreed on an accelerated regulatory pathway for the company’s VVN461LD, a potent JAK1/TYK2 inhibitor targeting inflammation follo...
Scottish Regulators Endorse Outlook’s Lytenava for NHS Scotland Use in Wet AMD
Outlook Therapeutics announced June 10 that the Scottish Medicines Consortium had recommended Lytenava (bevacizumab gamma) for use within its National Health Service system, NHS Scotland, for the t...
US FDA Aims to Speed Drug Review to Under Two Months With New Voucher Program
The US FDA reported June 17 the launch of a new priority review voucher program designed to review prescription drug applications within one to two months of submission. The current average is 10 t...
DEWS III Report Updates Guidelines for Diagnosis, Management of Dry Eye
The Tear Film and Ocular Surface Society (TFOS) has released DEWS III, its third set of reports exploring the diagnosis and management of dry eye disease. The findings of the TFOS Dry Eye Workshop ...
J&J Vision Launches Tecnis Odyssey PC-IOL in Europe, Middle East, and Canada
Johnson & Johnson Vision announced June 17 that it had rolled out the Tecnis Odyssey presbyopia-correcting intraocular lens (PC-IOL) in Europe, the Middle East, and Canada. The company, based in Ja...
Ascension Agrees to Buy Amsurg’s Network of ASCs
Ascension announced June 17 that it had agreed to acquire the Amsurg network of ambulatory surgery centers (ASCs). Terms were not disclosed. Amsurg operates more than 250 surgery centers in 34 stat...
Regeneron Declines to Submit New Bid for 23andMe After Higher Offer from Co-founder
Drugmaker Regeneron has declined to submit a new bid for genetic testing company 23andMe, a company spokesperson told Reuters on June 16. 23andMe reported June 13 that TTAM Research Institute, a no...
NIH Study Determines Brain Circuits Affected by Retinal Cell Loss
Researchers at the National Institutes of Health have determined which vision-processing cells in the brain are affected by damaged retinal ganglion cells (RGCs). Current vision restoration therapi...
Aldeyra Resubmits NDA to US FDA for Reproxalap in Dry Eye
Aldeyra Therapeutics announced June 17 that it had resubmitted its new drug application (NDA) to the US FDA for topical ocular reproxalap in dry eye. Aldeyra reported in May that reproxalap achieve...
US FDA Gives Green Light to Phase II/III Trial of Ocugen’s Stargardt Candidate
Ocugen announced June 16 that the US FDA had cleared an investigational new drug (IND) application for a Phase II/III trial of its OCU410ST subretinal gene therapy candidate for ABCA4-associated re...
Harrow Acquires US Rights to Formosa’s Clobetasol, Now Branded Byqlovi
Harrow announced June 9 that it had acquired the US commercial rights to Formosa Pharmaceuticals’ clobetasol propionate 0.05% eye drops for postsurgical inflammation and pain. According to a filing...
Spain’s Faes Farma Acquires Italy’s SIFI in Deal Worth $310.4 Million
Faes Farma, of Bilbao, Spain, announced June 11 that it had signed an agreement to acquire 100 percent of Italian ophthalmic company SIFI. The deal values SIFI at €270 million (US $310.4 million, c...
Qlaris Bio Will Advance Fixed-Dose Combo Therapy for Glaucoma with QLS‑111 and Latanoprost
Qlaris Bio announced June 11 that it is developing a preservative-free, fixed-dose combination therapy with its lead asset, QLS-111, and latanoprost, a common prostaglandin analog prescribed for gl...
Chinese Regulators Approve Clarus 700 Ultra-Widefield Fundus Camera from Zeiss
Germany’s Carl Zeiss Meditec announced June 6 that China’s National Medical Products Administration (NMPA) had approved the Clarus 700 high-definition, ultra-widefield fundus imaging system. The co...
Beacon Therapeutics Appoints Daniel Chung, DO, as Chief Medical Officer
Beacon Therapeutics announced June 9 that it had appointed Daniel Chung, DO, as chief medical officer. Chung most recently served as chief medical officer of the ophthalmic gene therapy company Spa...
ViGeneron Rebrands as VeonGen, Gains Rare Pediatric Nod for Stargardt Candidate
Germany’s ViGeneron announced June 5 its rebranding to VeonGen Therapeutics. VeonGen has advanced two gene therapy programs into clinical development—VG801 for Stargardt disease and other ABCA4-rel...
FDA Begins Listening Tour with Pharma CEOs to Improve Regulatory Process
The US FDA is holding a listening tour, led by FDA Commissioner Marty A. Makary, MD, MPH,to meet directly with pharmaceutical and biotech CEOs, according to an announcement on May 28. The goal is t...
EssilorLuxottica to Acquire European Ophthalmology Clinic Chain Optegra
Eyewear conglomerate EssilorLuxottica announced May 30 that it would acquire the Optegra chain of ophthalmology clinics from the private equity firm MidEuropa. Financial details were not disclosed....
Bausch + Lomb Launches Blink Nourish and Blink Boost OTC Eye Drops in US
Bausch + Lomb announced June 4 the US launch of Blink Nourish and Blink Boost over-the-counter lubricating eye drops. The company said both products are preservative-free and contact lens friendly;...
Sydnexis Gains EU Approval for Low-Dose Atropine Drops in Pediatric Myopia
Sydnexis announced June 5 that the European Commission had granted marketing authorization for SYD-101, the company’s low-dose atropine formulation for slowing the progression of pediatric myopia. ...
Outlook Launches Lytenava (Bevacizumab) in Germany, UK for Wet AMD
Outlook Therapeutics announced June 2 that it had launched Lytenava (bevacizumab gamma) in Germany and the UK for the treatment of wet age-related macular degeneration (AMD). The company said it wa...
US FDA Accepts Tenpoint’s NDA for Presbyopia Drop, Sets PDUFA Date of Jan. 28, 2026
Tenpoint Therapeutics announced June 3 that the US FDA had accepted its new drug application (NDA) for Brimochol PF, a combination eye drop candidate targeting presbyopia. The FDA set a Prescriptio...
23andMe Seeks New Bids after $305 Million Offer from its Co-founder
Bankrupt genetic testing company 23andMe told a US judge that it wants to reopen bidding on its assets after receiving a $305 million offer from its co-founder Anne Wojcicki, Reuters reported June ...
Gore Launches Silicone-Free Plunger for Ophthalmic Prefilled Syringes
Materials company W.L. Gore & Associates announced June 3 the commercial launch of its 0.5 mL silicone-free Improject syringe plunger. The new plunger is specifically designed for prefilled syringe...
US FDA Approves Alcon’s Tryptyr (Acoltremon) Drops for Dry Eye
Alcon announced May 28 that the US FDA had approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of the signs and symptoms of dry eye. The company ...
Bayer Receives Approval in China for High-Dose Eylea in Wet AMD
German drugmaker Bayer announced May 22 that China’s National Medical Products Administration had granted marketing authorization for high-dose Eylea (aflibercept 8 mg) for the treatment of wet age...
New Scleral Clamp Allows Delivery of Two Cell Grafts in Same Eye for Comparing Effects
Scientists with the National Institutes of Health have shown that a new surgical technique can successfully deliver two cell grafts in adjacent subretinal locations in the same eye—allowing direct ...
US FDA Sets Decision Date of Oct. 21 for Xbrane’s Lucentis Biosimilar Candidate
Sweden’s Xbrane Biopharma announced May 23 that the US FDA had accepted the resubmitted biologics license application (BLA) for its Lucentis (ranibizumab) biosimilar. The FDA set a decision date of...
EyeGo, Developer of Digital Ophthalmic Microdoser, Secures Strategic Investment from Topcon
Danish company EyeGo, developer of the MistGo Digital microdoser for ophthalmic medicine, announced May 16 a strategic investment from Topcon Healthcare. No financial details were disclosed. EyeGo ...
Formosa Licenses Clobetasol Drops to Adalvo for European, Brazilian Markets
Taiwan-based Formosa Pharmaceuticals announced May 28 that it had agreed to license to Malta’s Adalvo Limited exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical infla...
Deepeye TPS AI Support Tool for Wet AMD Treatment Gains CE Marking
Germany’s Deepeye Medical announced May 21 that its Deepeye TPS artificial intelligence assistant had been granted CE marking in the EU as a Class IIa medical device. The company said medical assis...
iVeena Submits IND to US FDA for Phase II Trial of IVMED-85 in Pediatric Myopia
iVeena Delivery Systems announced May 29 that it had submitted an investigational new drug (IND) application to the US FDA for a Phase II trial of IVMED-85 in pediatric myopia. IVMED-85 is a non-at...
Allotex Launches Refractive Corneal Implant in Canada
Allotex announced May 22 the approval and launch in Canada of Transform, its human collagen-based corneal implant for vision correction. The company said it had partnered with Clarion Medical Techn...
US FDA Grants Rare Pediatric Designation to Ocugen’s Gene Therapy Candidate for Stargardt
Ocugen announced May 27 that the US FDA had granted rare pediatric disease designation to its OCU410ST subretinal gene therapy candidate for ABCA4-associated retinopathies, including Stargardt dise...
Atia Vision Gains IDE Approval to Begin US Trial of Modular Accommodating IOL
Atia Vision announced May 20 that the FDA had approved its investigational device exemption (IDE) application to begin a US feasibility study of its OmniVu modular accommodating lens system for cat...
Q1-2025 Ophthalmic Revenue Roundup for Bausch + Lomb and Carl Zeiss Meditec
Bausch + Lomb reported April 30 that its Q1-2025 revenue was $1.14 billion, a 3 percent increase (+5 percent cc) over $1.10 billion in Q1-2024. Vision Care segment revenue in Q1-2025 was $656 milli...
US FDA Gives Green Light to Phase II Trial of Immunoglobulin Eye Drop from Selagine, Grifols
Chicago-based Selagine and its partner Grifols, of Barcelona, Spain, announced May 21 that the US FDA had cleared an investigational new drug (IND) application for a Phase II trial of their GRF312 ...
Dyno Launches New Capsid for Ophthalmic Gene Therapy Developers
Dyno Therapeutics, of Watertown, Massachusetts, has launched a new adeno-associated virus (AAV) capsid for ophthalmic gene therapies, in addition to capsids for neuromuscular and central nervous sy...
Regeneron Buys 23andMe, Says Move will Strengthen its Genetics-Guided Drug Development
Regeneron, of Tarrytown, New York, reported May 19 that it had been named the successful bidder in a bankruptcy auction for the assets of 23andMe, a company that provides direct-to-consumer genetic...
SIFI Gains Marketing Authorization, PIM Designation for Akantior Drops in UK
Italy’s SIFI reported May 19 that it had gained marketing authorization from the UK’s Medicines and Healthcare Products Regulatory Agency for Akantior eye drops for the treatment of Acanthamoeba ke...
US FDA Approves Genentech’s Susvimo Refillable Implant for DR
Genentech, a member of the Roche Group, announced May 22 that the US FDA had approved Susvimo, a refillable ranibizumab implant, for diabetic retinopathy (DR). The South San Francisco, California, ...
Two AI-Driven Drug Discovery Firms Win 2025 Astellas Future Innovator Prize
Two AI-driven drug discovery companies—DeepSeq.AI and Serna Bio—have won the 2025 Astellas Future Innovator Prize. The accelerator competition, in its sixth year, is offered by drugmaker Astellas P...
Regenxbio Moves to Monetize Future Royalties in Deal Worth up to $250 Million
Gene therapy developer Regenxbio announced May 19 that it had closed a non-dilutive royalty bond agreement worth up to $250 million with Healthcare Royalty (HCRx). The Rockville, Maryland, company ...
New World Medical Launches New Streamline with Transparent Tip
New World Medical announced May 14 the launch of an enhanced Streamline viscodilation handpiece for glaucoma surgery, featuring a transparent tip designed for improved visualization of key anatomic...
US FDA Grants Breakthrough Status to Belite Bio’s Oral Stargardt Candidate
Belite Bio announced May 21 that the US FDA had granted breakthrough therapy status to tinlarebant, an oral tablet targeting Stargardt disease. Sponsor companies receiving breakthrough designation ...
Nearly 76 Thousand Cases of Ocular Lubricants Recalled, US FDA Alert Says
The US FDA issued alerts recently regarding the recalls of five ocular lubricant products and one generic glaucoma medication. BRS Analytical Services, a contract testing laboratory based in St. Lo...
Intalight Receives CE Marking for Dream OCT Swept Source Imaging
Ophthalmic diagnostic company Intalight announced May 15 that it had received CE marking for its Dream optical coherence tomography (OCT) platform. Intalight, with offices in San Jose, California, ...
Bausch + Lomb Receives CE Marking for Preloaded LuxLife Trifocal IOL
Bausch + Lomb announced May 7 that the LuxLife trifocal intraocular lens (IOL) had received CE marking in Europe. The company said the nondiffractive LuxLife has an uninterrupted, continuous refrac...
Q1-2025 Ophthalmic Revenue Roundup for Alcon, Immunocore, Harrow, Sight Sciences, ANI, Iridex, and Xbrane
Alcon reported May 13 that its Q1-2025 net sales were $2.45 billion, on par with $2.44 billion in Q1-2024 and up 3 percent on a constant currency basis. Surgical net sales totaled $1.33 billion (do...
Lenz Licenses Presbyopia Drop Candidate to Lotus Pharmaceutical for Korea, Southeast Asia
Lenz Therapeutics announced May 9 a license agreement with Taiwan’s Lotus Pharmaceutical for exclusive rights to market LNZ100 (1.75% aceclidine) for presbyopia in South Korea and certain countries...
US FDA Grants Breakthrough Status to Viridian’s Thyroid Eye Disease Candidate
Viridian Therapeutics announced May 7 that the US FDA had granted breakthrough therapy status to veligrotug, the company’s anti-insulin-like growth factor-1 receptor (IGF-1R) candidate for thyroid ...
Unity Bio to Cut Workforce, Seek Strategic Alternatives for UBX1325 in Retina
Unity Biotechnology announced May 5 that it would reduce its workforce and seek an established ophthalmic company to continue the development of UBX1325, a Tie2/anti-VEGF bispecific antibody candid...
Maximilian Foerst to Lead Carl Zeiss Meditec, as Markus Weber, PhD, Steps Down
Carl Zeiss Meditec announced May 7 that Markus Weber, PhD, the company’s president and CEO, will step down of his own accord, effective May 31. Replacing Weber will be Maximilian Foerst, currently ...
TME Pharma to Expand Cost-Cutting, Nominate New CEO
Germany’s TME Pharma, a clinical-stage cancer company, announced May 5 that it would expand its cost-cutting measures by outsourcing staffing and nominate Diede van den Ouden for appointment as CEO...
Topcon Healthcare Acquires RetInSight to Advance AI-Powered Imaging in Eye Care
Topcon Healthcare announced May 2 that it had acquired privately held retinal AI analysis company RetInSight, of Austria. No financial details were disclosed. The companies forged a partnership in ...
Q1-2025 Ophthalmic Revenue Roundup for Amgen, Hoya, Apellis, Tarsus, STAAR, RxSight, and Ocular Therapeutix
Amgen, of Thousand Oaks, California, reported May 1 that its Q1-2025 revenue from Tepezza was $381 million, a 10 percent decrease from $424 million in Q1-2024. The total consisted of $365 million...
Elanco Sells US Royalty and Milestone Rights for Xdemvy to Blackstone for $295 Million
Elanco, of Greenfield, Indiana, announced May 5 that it had sold certain future US tiered royalties and commercial milestone payments associated with Tarsus’ Xdemvy (lotilaner ophthalmic solution 0...
Okyo Pharma Accelerates Development of Urcosimod in Neuropathic Corneal Pain
London’s Okyo Pharma announced April 30 that it would accelerate development of urcosimod, formerly OK-101, in neuropathic corneal pain, following early closure of its Phase II trial. The trial was...
US FDA Grants Marketing Clearance for OcuSciences’ OcuMet Beacon Retinal Imager
OcuSciences, of Ann Arbor, Michigan, announced May 1 that the US FDA had granted marketing clearance for its flagship device, the OcuMet Beacon retinal imager. The 510(k) clearance describes the Oc...
RetinAI and FVS Gain CE Marking for LuxIA DR Screening Algorithm
Switzerland’s RetinAI and Spain’s Fundación Ver Salud (FVS) announced April 30 that LuxIA, their co-developed artificial intelligence algorithm for diabetic retinopathy screening, had received CE m...
Aldeyra Achieves Primary Endpoint in Phase III Dry Eye Chamber Trial of Reproxalap, Plans NDA Resubmission
Aldeyra Therapeutics reported May 5 that topical reproxalap achieved the primary endpoint of statistically significant improvement in ocular discomfort vs. vehicle in a Phase III dry eye chamber tr...
US FDA Grants RMAT Status to Opus’ LCA5 Gene Therapy Candidate
Opus Genetics announced May 6 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to OPGx-LCA5, its investigational gene therapy for the treatment of Leber congeni...
US FDA Grants RMAT Status to 4DMT’s Gene Therapy Candidate in DME
4D Molecular Therapeutics announced May 1 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to 4D-150, an intravitreal gene therapy candidate for diabetic macula...
US FDA Extends Luminopia Amblyopia Treatment Clearance to Children Ages 8 to 12
Luminopia announced April 22 that the US FDA had cleared its amblyopia (lazy eye) treatment for patients ages 8 to 12, extending the age range of its existing label. The Luminopia system was grante...
Q1-2025 Ophthalmic Revenue Roundup for Roche, Regeneron, AbbVie, Glaukos, Lumibird, and Biogen
Swiss company Roche reported April 24 that Vabysmo sales in Q1-2025 were CHF 1 billion ($1.1 billion, calculated March 31, 2025), up 18 percent in constant currency from CHF 847 million in Q1-2024....
New Laws in Montana, West Virginia Expand ODs’ Scope to Include Laser
Montana and West Virginia became the 13th and 14th US states, respectively, to pass laws expanding optometrists’ scope of practice to include in-office laser procedures. West Virginia’s measure spe...
Formosa Licenses Clobetasol Propionate Drops to Chile’s Saval for Latin America
Taiwan-based Formosa Pharmaceuticals announced April 25 that it had agreed to license to Chile’s Laboratorios Saval exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical...
NanoDrops Names Daria Lemann-Blumenthal as CEO
Israel’s NanoDrops announced April 22 that it had appointed Belkin Vision co-founder Daria Lemann-Blumenthal as its new chief executive officer. NanoDrops, founded in 2020, employs a laser-etched p...
Allotex Ramps Up Commercialization of Presbyopia Implant, Appoints Michael Mrochen, PhD, as CEO
Allotex announced April 23 the acceleration of commercialization of its human collagen-based corneal implant for presbyopia—along with the appointment of company co-founder Michael Mrochen, PhD, as...
CSI Dry Eye Software Appoints Ken Barbet as CEO
CSI Dry Eye Software, an artificial intelligence-based platform to aid dry eye disease diagnosis and management, announced April 23 that it had appointed Ken Barbet as chief executive officer. CSI ...
Aurion Biotech Appoints Edward J. Holland, MD, as Chief Medical Officer
Aurion Biotech announced April 23 that it had appointed Edward J. Holland, MD, as chief medical officer. Aurion’s lead asset is AURN001, being developed for corneal edema secondary to corneal endot...
Design Therapeutics Appoints Chris M. Storgard, MD, as Chief Medical Officer
Design Therapeutics announced April 17 that it had appointed Chris M. Storgard, MD, as chief medical officer (CMO). The Carlsbad, California, company is developing DT-168, a small molecule targetin...
Bausch + Lomb Ends Recall of enVista IOLs After Tracking Source of Contamination
Bausch + Lomb announced April 24 that it was ending its voluntary recall of enVista intraocular lenses (IOLs) after it tracked the source of contamination to a raw material used in certain lots tha...
GA Patients in Eyestem Phase I Cell Therapy Trial Show Significant Vision Improvement
India’s Eyestem Research reported April 15 that patients with geographic atrophy (GA) in a Phase I trial of its Eyecyte-RPE cell therapy saw significant vision improvement. Eyecyte-RPE is a cryopre...
Four Eylea Biosimilars Get Q-Codes for Billing Payers in the US
The Centers for Medicare and Medicaid Services (CMS) issued product-specific Q-codes for four Eylea biosimilars during Q4-2024 and Q1-2025. Q-codes are billing codes for reimbursement that are simi...
Alcon Rolls Out Unity VCS and CS Systems at ASCRS Meeting
Alcon announced April 25 the launch of its dual-function Unity Vitreoretinal Cataract System (VCS) and stand-alone Unity Cataract System (CS) in four markets, including the US. The announcement cam...
Veo Launches Plexitome to Treat Recurrent Corneal Erosion, Corneal Abrasions
Veo Ophthalmics, of Chester, Ohio, announced April 14 that it had launched its Plexitome surgical instrument for the treatment of recurrent corneal erosion and large corneal abrasions. The FDA-regi...
US FDA Rejects Regeneron’s sBLA for Eylea HD Dosing Interval Beyond 16 Weeks
Regeneron announced April 18 that the US FDA had issued a complete response letter rejecting the company’s supplemental biologics license application (sBLA) to add extended dosing intervals up to e...
Ballooning NHS Cataract Surgery Costs at Private Clinics Raise Red Flags
Fraud investigators in England’sNational Health Service (NHS) are looking at the billing practices of private clinics delivering NHS cataract surgery after procedure volume and costs have ballooned...
New Mexico Governor Vetoes Bill to Allow ODs to Perform SLT, YAG Capsulotomy
New Mexico Gov. Michelle Lujan Grisham on April 11 vetoed House Bill 36, which would have expanded the scope of practice for optometrists in the state, allowing them to perform selective laser trab...
Microsurgical Technology to Distribute MANI’s Ophthalmic Blade Portfolio in US
Microsurgical Technology (MST) announced April 17 that, under a new strategic partnership, it would distribute the ophthalmic surgical blade portfolio of Japan’s MANI in the US. The deal is concurr...
Senju Licenses Brill’s Non-contact Esthesiometer for Japan
Japanese company Senju Pharmaceutical reported March 7 that it had licensed Brill International’s corneal esthesiometer for use in Japan. Senju said the device mainly had been distributed by Brill ...
May 12 is Deadline to Apply for Ramin Tadayoni Award for Research
Applications are open until May 12, 2025, for this year’s Ramin Tadayoni Award, offered by the European Society of Retina Specialists, or Euretina, and supported by Oculis as a tribute to retina sp...
Biocon Reaches Settlement, License Agreement with Regeneron to Bring Yesafili to Market in US
India’s Biocon Biologics reported April 15 that it had reached a settlement and license agreement with Regeneron that clears the way for Biocon to commercialize Yesafili, a biosimilar to Eylea, in ...
US FDA Grants 510(k) Clearance to BVI’s Laser Endoscopy System for Glaucoma
BVI Medical announced April 17 that it had received US FDA 510(k) clearance for its Leos laser endoscopy system for glaucoma. The company said Leos offers a more intuitive, minimally invasive ab in...
Sanoculis Receives CE Marking for MINT Procedure for Glaucoma
Israel’s Sanoculis announced April 17 that it had received CE marking in the EU for its MINT (minimally invasive nasal trabeculostomy) procedure for adults with glaucoma. MINT features a mechanical...
J&J Vision Reports Q1-2025 Surgical Revenue of $361 Million
J&J Vision’s Q1-2025 global surgical revenue totaled $361 million, a 3.7 percent increase (+6.2 percent cc) over $348 million in Q1-2024, parent Johnson & Johnson, of New Brunswick, New Jersey, rep...
Cambridge Innovation Institute Absorbs Healthegy’s OIS, OIS Retina Conferences
Cambridge Innovation Institute, of Needham, Massachusetts, announced April 10 that it would expand its health care event calendar by taking on Healthegy’s ophthalmic conferences—the Ophthalmology I...
US FDA Plans to Phase Out Animal Testing for Biologics, Drugs
The US FDA reported April 10 that it planned to phase out animal testing as part of the approval process for biologics and drugs, as the agency moves to more effective, human-relevant methods, call...
ACRO Biomedical Gains Regulatory Approval in Taiwan for Corneal Xenograft
Taiwan’s ACRO Biomedical announced April 13 that the country’s Ministry of Health and Welfare had granted regulatory approval to ACRO’s ABCcolla decellularized porcine collagen corneal xenograft. A...
Opthea Will Lay Off 65 Percent of Employees after Phase III Wet AMD Failures
Opthea plans to lay off about 65 percent of its workforce, effective May 1, the company said in a corporate update filed April 10 with the with the US Securities and Exchange Commission (SEC). The ...
US FDA Grants RMAT Status to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
Atsena Therapeutics announced April 15 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS...
Tenpoint Submits NDA to US FDA for Brimochol PF in Presbyopia
Tenpoint Therapeutics announced April 8 that it had submitted a new drug application (NDA) to the US FDA for Brimochol PF, a combination eye drop candidate targeting presbyopia. In its Phase III tr...
Nordic Pharma Secures CE Marking for Lacrifill Canalicular Gel in Dry Eye
Nordic Group B.V., a Dutch affiliate of Nordic Pharma, announced April 7 that Lacrifill canalicular gel had received CE marking in Europe for the treatment of dry eye. Lacrifill is a cross-linked h...
US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27
Outlook Therapeutics announced April 8 that the US FDA had accepted the resubmitted biologics license application (BLA) for ONS-5010 (bevacizumab-vikg, Lytenava), an ophthalmic formulation of bevac...
US FDA Issues Update on Bausch + Lomb enVista IOL Recall
The US FDA issued an update April 7 with more details on Bausch + Lomb’s voluntary recall of certain intraocular lenses (IOLs) on its enVista platform. The update listed the affected lenses: —enVis...
Orasis Launches Qlosi Presbyopia Drops in US
Orasis Pharmaceuticals announced April 7 that Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% eye drops for the treatment of presbyopia are now available to prescribe in the US. Orasis s...
Chinese Regulators Approve Tapcom Fixed-Combo Glaucoma Drop from Santen
Japan’s Santen announced April 4 that China’s National Medical Products Administration had approved the marketing authorization application for Tapcom (tafluprost 0.0015%/timolol maleate 0.5% ), a ...
Onconetix Signs Letter of Intent for Potential Business Combination with Ocuvex
Onconetix, of Cincinnati, Ohio, announced April 8 that it had signed a non-binding letter of intent contemplating a potential business combination with Ocuvex, maker of Omlonti (omidenepag isopropy...
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...
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...
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