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.
Regulation News
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...
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 ...
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...
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...
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...
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...
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...
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...
Select US FDA Approvals and Clearances in March 2025
There was one US FDA clearance through the ophthalmic device division using the 510(k) pathway in March 2025, according to the agency’s database. CenterVue gained approval for its Maia scanning las...
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...
PDUFA Dates for Ophthalmic Drug Candidates, April 2025
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
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...
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...
Job and Funding Cuts in US HHS Department Hit Ophthalmic Community
The Trump administration’s overhaul of the US Health and Human Services Department (HHS) through mass firings, funding cuts, and restructuring continues to affect those working to protect vision. J...
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...
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...
April 2025 Ophthalmic News Briefs
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 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...
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...
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...
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 ...
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...
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 ...
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 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...
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 ...
Changes in NIH Grant Rules Threaten to Ripple Through Eye Disease Research
Any changes to the rules that accompany US government research grants could affect eye research in the US in a big way. The US government awards an average of $1.1 billion a year in grants to resea...
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...
PDUFA Dates for Ophthalmic Drug Candidates
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
Select US FDA Approvals and Clearances in February 2025
There was one US FDA clearance through the ophthalmic device division using the 510(k) pathway in February 2025, according to the agency’s database. New World Medical gained clearance of its Via360...
US FDA Accepts NDA for Glaukos’ Epioxa for Epi-On Crosslinking Therapy
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...
New Arkansas Law Reins in Vision Care Insurers’ Influence over ODs
Optometrists in Arkansas celebrated a legislative victory on Feb. 25 when Gov. Sarah Huckabee Sanders signed into law HB 1353, which supporters say will allow ODs in the state to receive more fair ...
Medicare Physician Fee Cut Won’t be Rolled Back in March
US House members on March 9 dropped language from a stopgap funding bill that would have rolled back the 2.83 percent cut in Medicare reimbursement for doctors that went into effect Jan. 1. The mov...
New World Medical Gains US 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...
Weekly Corporate and Surgeon Poll, March 2025
March 2025 Ophthalmic News Briefs
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...
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 ...
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...
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...
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...
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...
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...
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...
Australian Regulators Approve Apellis’ Syfovre for Patients with 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...
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...
Select US FDA Approvals and Clearances in January 2025
There were no US FDA clearances through the ophthalmic device division using the 510(k) pathway in January 2025, according to the agency’s database. This is a departure from previous months, when i...
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...
Ophthalmology Officials, Doctors, Researchers Feel Effects of Trump’s Sweeping Changes
The US ophthalmic community and larger health care industry have been affected by many policies implemented by the Trump administration since inauguration day on Jan. 20. Among the 3,600 employees ...
February 2025 Ophthalmic News Briefs
Outlook Therapeutics reported Jan. 16 the final results of the NORSE EIGHT trial of ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet AMD. ONS-5010 demonstrated non-inferiority ...
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...
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)...
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...
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...
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...
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...
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...
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...
Select US FDA Approvals and Clearances in December 2024
The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in December 2024, according to the agency’s database. AI Optics gained clearance for its Sentinel ...
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,...
US FDA PDUFA Dates for Ophthalmic Drug Candidates
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
2024 in Review: MAC Turmoil Shakes Out with Final Policy on Coverage of MIGS
Five of the seven US Medicare Contract Administrators ended a two-year roller coaster ride for the glaucoma surgery market in mid-November by publishing for the second time their final coverage pla...
2024 in Review: LumiThera’s Valeda is First Treatment for Early, Intermediate Dry AMD
The US FDA granted market authorization to LumiThera’s Valeda Light Delivery System as a de novo device on Nov. 4, making it the first treatment of any kind, device or drug, to receive the FDA’s ba...
2024 in Review: Change Healthcare and Hoya Data Breaches Highlight Security Risks
The health care and public health sector was the most common ransomware target of any critical US infrastructure sector in 2023 and 2024, according to the FBI. By October 2024, the American Hospita...
January 2025 Ophthalmic News Briefs
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...
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...
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...
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...
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...
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...
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...
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), ...
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...
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...
Zeiss Gains US Approval for Next-Gen 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...
Select US FDA Approvals and Clearances in November 2024
The US FDA granted one clearance through the ophthalmic device division using the 510(k) pathway in November 2024, according to the agency’s database. Novoxel, a newcomer to ophthalmology but not m...
PDUFA Dates for Ophthalmic Drug Candidates
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
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...
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...
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...
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...
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...
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...
December 2024 Ophthalmic News Briefs
Dutch company Ophtec announced Nov. 18 that it had gained CE marking for its Artiplus phakic IOL. The company said the lens offered a solution for relatively young presbyopes, typically in their ea...
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...
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...
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...
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...
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 ...
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...
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...
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-...
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 Asks for Added Data on Neurotech MacTel Candidate, Delays 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 Grants De Novo Classification to LumiThera’s System for Dry AMD
LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobio-modulation system for treatment of patients with dry age-related macu...
Select US FDA Approvals and Clearances in October 2024
The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in October 2024, according to the agency’s database. Apple gained clearance for its Digital Prism ...
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...
AAO Puts FDA Deputy Director of Ophthalmology on the Hot Seat
William Boyd, MD, deputy director of ophthalmology at the US FDA’s Office of New Drugs, had a quick answer when asked to name the biggest unmet need in ophthalmology. “We need and want more therapi...
Emerging Companies Pursuing Ophthalmic Indications, November 2024
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
November 2024 Ophthalmic News Briefs
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...
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...
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...
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...
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) ...
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...
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...
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. ...
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...
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...
AbbVie Withdraws EU Marketing Application for Durysta Implant for Glaucoma
Europe’s Committee for Medicinal Products for Human Use (CHMP) announced Sept. 19 that AbbVie had withdrawn its marketing authorization application for the sustained-release glaucoma implant Duryst...
Select US FDA Approvals and Clearances in September 2024
The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in September 2024, according to the agency’s database. Zeiss gained clearance for its combination Y...
ESCRS iNovation Day Looks at MDR Roadblocks, Global Care Issues
The impact of Europe’s new Medical Device Regulation (MDR) on innovation sparked considerable discussion during the ESCRS iNovation Day. The meeting was held Sept. 6 in Barcelona, Spain, ahead of t...
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on Sept. 19 for two new aflibercept (Eylea) biosimilars—Afqlir from Swiss drugmaker Sandoz and Opuviz, which ...
FTC Sends More Than $1.1 Million to Consumers Misled by LCA-Vision Ads
The Federal Trade Commission (FTC) announced Oct. 3 that it was sending more than $1.1 million in settlement payments to consumers who were misled by deceptive bait-and-switch advertising by LCA-Vi...
October 2024 Ophthalmic News Briefs
Oculus has announced the addition of frequency doubling perimetry (FDP) to its Easyfield VR visual field diagnostic headset. The German ophthalmic diagnostic company, with US headquarters in Arling...
FDA Names New Leaders at OPEQ and CDHR
Ross Segan, MD, MBA, FACS, has become director of the US FDA’s Office of Product Evaluation and Quality (OPEQ). The office, part of FDA’s Center for Devices and Radiological Health (CDRH), oversees...
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...
FTC Sends More Than $1.1 Million to Consumers Misled by LCA-Vision Ads
The Federal Trade Commission (FTC) announced Oct. 3 that it was sending more than $1.1 million in settlement payments to consumers who were misled by deceptive bait-and-switch advertising by LCA-Vi...
Rayner Begins US Study of RayOne Galaxy Trifocal Spiral IOL
UK-based Rayner reported Oct. 1 that the first RayOne Galaxy lenses had been implanted in the US as part of an FDA investigational device exemption (IDE) study. Rayner describes the Galaxy, a trifo...
US FDA Removes Clinical Hold on Ocugen’s IND for OCU200 in DME
Ocugen announced Oct. 9 that the US FDA had lifted its clinical hold on the investigational new drug (IND) application for a Phase I trial of OCU200, a recombinant fusion protein consisting of tums...
Eyenovia Launches Clobetasol Drops for Postoperative Pain, Inflammation
Eyenovia announced Sept. 26 the US launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, known as Clobetasol, for postoperative inflammation and pain following oc...
EU Regulators Approve Vevizye from Novaliq; Théa Will Commercialize Dry Eye Drop
Germany’s Novaliq announced Oct. 2 that the European Commission had approved its dry eye treatment Vevizye (cyclosporine ophthalmic solution) 0.1%. The product is indicated for the treatment of mod...
Ross Segan, MD, MBA, FACS, Takes Helm of FDA’s OPEQ
Ross Segan, MD, MBA, FACS, has becomedirector of the US FDA’s Office of Product Evaluation and Quality (OPEQ). The office, part of FDA’s Center for Devices and Radiological Health (CDRH), oversees ...
Aurion Launches Vyznova Corneal Cell Therapy in Japan
Aurion Biotech announced Sept. 24 that it had launched Vyznova (neltependocel), a cell therapy for bullous keratopathy of the cornea, in Japan. Japanese regulators approved Vyznova in March 2023. T...
US FDA Grants Fast Track Designation to Priovant’s Uveitis Candidate
Priovant Therapeutics, of Durham, North Carolina, reported Sept. 23 that the US FDA had granted fast track designation for brepocitinib in non-infectious intermediate or posterior uveitis or panuve...
US FDA Grants Orphan Drug Status to Atsena’s XLRS Gene Therapy Candidate
Atsena Therapeutics announced Sept. 17 that ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS), had received the US FDA’s orphan drug designation. The candidate was granted rare...
AbbVie Withdraws EU Marketing Application for Durysta
Europe’s Committee for Medicinal Products for Human Use (CHMP) announced Sept. 19 that AbbVie had withdrawn its marketing authorization application for the sustained-release glaucoma implant Duryst...
Tepezza Receives Approval in Japan to Treat Active Thyroid Eye Disease
Amgen reported Sept. 24 that Tepezza had gained approval in Japan for the treatment of active or high clinical activity score thyroid eye disease (TED). The Thousand Oaks, California, company said ...
Apellis Receives Negative CHMP Opinion on Pegcetacoplan in GA After Re-examination
Apellis Pharmaceuticals announced Sept. 20 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had reaffirmed its June 2024 negative opinion on the company’s ...
US FDA Warns Regener-Eyes Maker Over Plant Conditions, Unapproved Products
The US FDA has sent a warning letter to Regenerative Processing Plant in Palm Harbor, Florida, finding fault with its manufacturing processes and raising concerns that its eye drop products may sti...
Indian Regulators Approve First Ophthalmic AI Software—Medios DR from Remidio
India’s Remidio announced Sept. 13 that regulators there had approved its Medios DR software for autonomous detection of diabetic retinopathy (DR). Medios DR becomes the first ophthalmic artificial...
Nicox Reports that Ocumension Has Gained Approval for Zerviate in China
France’s Nicox announced Sept. 18 that partner Ocumension Therapeutics had received regulatory approval in China to commercialize Nicox’ Zerviate (cetirizine ophthalmic solution) 0.24% for ocular i...
EC Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis
Italy’s SIFI announced Aug. 26 that the European Commission had approved Akantior (polihexanide 0.08%) drops for the treatment of Acanthamoeba keratitis (AK), a parasitic infection of the eye, in p...
Select US FDA Approvals and Clearances in August 2024
The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in August 2024, according to the agency’s database. Notably, newcomer Intelon Optics received clea...
Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error
Swiss company Oculis reported Aug. 27 in its Q2-2024 financial statement that it was shutting down the Phase III OPTIMIZE-2 trial of its OCS-01 eye drop candidate for postsurgical inflammation and ...
Precision Lens and Estate of Paul Ehlen to Pay US $12M over Kickbacks
Minnesota-based ophthalmic distributor Precision Lens and the estate of co-founder Paul Ehlen have agreed to pay the US government $12 million to resolve a case involving kickback payments in vario...
Six States Sue Regeneron over Eylea Drug Price Reporting
The attorneys general for Colorado, Georgia, Michigan, North Carolina, Texas, and Washington have filed suit in federal district court against Regeneron Pharmaceuticals, claiming the drugmaker infl...
September 2024 Ophthalmic News Briefs
Bausch + Lomb is working with Goldman Sachs to explore a sale of the company, the Financial Times reported Sept. 14, with private equity the most likely buyer. The move is being evaluated as a way ...
US FDA Gives Go-Ahead to Trial of BlueRock’s Cell Therapy Candidate for Photoreceptor Diseases
Bayer subsidiary BlueRock Therapeutics announced Sept. 3 that the US FDA had cleared its investigational new drug application for a Phase I/IIa trial of OpCT-001, an induced pluripotent stem cell (...
US FDA Grants Orphan Drug Status to Skyline’s Gene Therapy Candidate for RP
China’s Skyline Therapeutics announced Sept. 3 that the US FDA had granted orphan drug designation to SKG1108, an intravitreal gene therapy candidate for retinitis pigmentosa (RP). SKG1108 is a rec...
NovaSight Gains Approval in China for CureSight System for Amblyopia
Israel-based NovaSight reported Sept. 4 that its CureSight eye-tracking system for amblyopia in children had gained approval from Chinese regulators, expanding the device’s availability to the thre...
Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error
Swiss company Oculis reported Aug. 27 in its Q2-2024 financial statement that it was shutting down the Phase III OPTIMIZE-2 trial of its OCS-01 eye drop candidate for postsurgical inflammation and ...
Health Canada Gives Green Light to Phase III Trial of Ocugen’s Gene Therapy Candidate for RP
Ocugen announced Aug. 26 that Health Canada had cleared the way for a Canadian Phase III trial of OCU400, a modifier gene therapy candidate for retinitis pigmentosa (RP). Ocugen, of Malvern, Pennsy...
European Commission Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis
Italy’s SIFI announced Aug. 26 that the European Commission had approved Akantior (polihexanide 0.08%) drops for the treatment of Acanthamoeba keratitis (AK), a parasitic infection of the eye, in p...
Precision Lens and Estate of Paul Ehlen to Pay US $12M over Kickbacks
Minnesota-based ophthalmic distributor Precision Lens and the estate of co-founder Paul Ehlen have agreed to pay the US government $12 million to resolve a case involving kickback payments in vario...
Six States Sue Regeneron over Eylea Drug Price Reporting
The attorneys general for Colorado, Georgia, Michigan, North Carolina, Texas, and Washington have filed suit in federal district court against Regeneron Pharmaceuticals, claiming the drugmaker infl...
EMA Accepts Marketing Application for Aflibercept (Eylea) Biosimilar from Alvotech
Biosimilar company Alvotech and its partner Advanz Pharma announced Aug. 15 that the European Medicines Agency (EMA) had accepted a marketing authorization application for AVT06, Alvotech’s propose...
European Five Market Expected to Grow, Despite MDR Delays
Device makers’ added costs for compliance with the new Medical Device Regulation (MDR) in the European Union (EU) will likely affect the mix of ophthalmic products and companies in the region. Howe...
US FDA Grants Tentative Approval to Generic Brimonidine Tartrate Ophthalmic Solution (Lumify) from Lupin
Indian drugmaker Lupin announced Aug. 14 that it had received tentative approval from the US FDA for its abbreviated new drug application for brimonidine tartrate ophthalmic solution 0.025%, a gene...
US FDA Grants Rare Pediatric Disease Designation to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
Atsena Therapeutics announced Aug. 14 that ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS), had received the US FDA’s rare pediatric disease designation. XLRS is a monogenic ...
US FDA Grants Rare Pediatric Disease Designation to Opus’ LCA5 Gene Therapy Candidate
Opus Genetics announced Aug. 20 that OPGx-LCA5, its gene therapy candidate for Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene, had received the US FDA’s rare p...
Eyenovia Plans to Seek US FDA Clearance for Gen-2 Optejet Microdoser
Eyenovia announced in its Q2-2024 financial results that it planned to seek marketing clearance for an advanced Gen-2 Optejet microdoser. Eyenovia, of New York, said production was expected to begi...
NEI Would Fold into Another NIH Institute Under Lawmaker’s Proposed Restructuring
The status of the National Eye Institute (NEI) as a separate unit within the National Institutes of Health (NIH) would come to an end under a proposal by a US House committee chair to consolidate t...
Select US FDA Approvals and Clearances in July 2024
The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in July 2024, according to the agency’s database. Topcon gained clearance for its Maestro2 OCT in c...
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