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.
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...
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...
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...
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...
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...
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 ...
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....
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 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 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...
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...
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...
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-...
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...
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...
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...
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 ...
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...
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...
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
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 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...
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...
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...
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...
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 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...
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 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. ...
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...
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...
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...
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...
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 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 ...
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...
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...
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 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 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...
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...
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...
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 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...
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, 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 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...
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...
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...
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...
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 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 ...
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...
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...
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...
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...
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...
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 ...
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...
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...
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 ...
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 (...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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 ...
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 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...
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...
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...
ViaLase announced July 30 that the European Union had granted CE marking for its ViaLase Laser for the treatment of adults with primary open-angle glaucoma. The system uses an OCT-guided femtosecon...
Patients with blepharospasm, a rare ophthalmic disease, are facing a proposal by five of the seven Medicare administrative contractors (MACs) to limit the botulinum toxin injections that control th...
Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US. The US FDA approved the supplemental new drug application for t...
Swiss drugmaker Sandoz announced Aug. 12 that the US FDA had approved Enzeevu, an aflibercept (Eylea) biosimilar, for wet age-related macular degeneration (AMD). Enzeevu (aflibercept-abzv) will be ...
Lenz Therapeutics announced Aug. 12 that it had submitted a new drug application to the US FDA for LNZ100, a once-daily, preservative-free eye drop candidate for presbyopia. Lenz, of San Diego, Cal...
Indian drugmaker Lupin announced Aug. 5 that the US FDA had approved its abbreviated new drug application for prednisolone acetate ophthalmic suspension, 1%, a generic equivalent of AbbVie’s Pred F...
LumiThera announced Aug. 7 that a new Category III CPT code had been established, effective Jan. 1, 2025, to report “Photobiomodulation therapy of retina, single session.” The company said the code...
Ocugen announced Aug. 5 that the US FDA had approved an expanded access program to allow for the treatment of adults with retinitis pigmentosa (RP) with OCU400—a modifier gene therapy product candi...
Patients with blepharospasm, a rare ophthalmic disease, are facing a proposal by five of the seven Medicare administrative contractors to limit the botulinum toxin injections that control their sym...
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...
ViaLase announced July 30 that the European Union had granted CE marking for its ViaLase Laser for the treatment of adults with primary open-angle glaucoma. The system uses an OCT-guided femtosecon...
Swiss drugmaker Roche announced July 30 that the European Commission had approved Vabysmo for a third indication, the treatment of macular edema due to retinal vein occlusion (RVO). Vabysmo (farici...
Germany’s Novaliq announced July 29 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for Vevi...
Theriva Biologics, of Rockville, Maryland, announced July 31 that the US FDA had granted rare pediatric drug designation for VCN-01, its treatment candidate for retinoblastoma. The FDA had already ...
Adverum Biotechnologies announced Aug. 1 that Ixo-vec, its intravitreal gene therapy candidate for wet age-related macular degeneration (AMD), had received the US FDA’s regenerative medicine advanc...
Italy’s SIFI announced July 22 that a European advisory panel had recommended orphan drug designation for its polihexanide eye drop for fungal keratitis. The Committee for Orphan Medicinal Products...
Balance Ophthalmics has gained US FDA de novo classification for its FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system, a goggles and pump system designed to lower intraocular pressure (IOP) i...
The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in June 2024, according to the agency’s database. Alcon gained clearance for its much-anticipated ...
The US FDA announced July 1 that it was expanding its TAP pilot program in October to include ophthalmic devices, as well as radiological health devices. The voluntary program, officially named the...
Private insurers involved in the US Medicare Advantage program added hundreds of thousands of questionable diagnoses, including those for diabetic cataracts, to patient records in recent years to b...
Genentech, a member of the Roche Group, announced July 5 that the US FDA had approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD...
Bausch + Lomb announced July 23 that it had acquired dry eye diagnostic company Trukera Medical from its private equity owner, AccelMed Partners, and other shareholders. No financial details were d...
Private insurers involved in the US Medicare Advantage program added hundreds of thousands of questionable diagnoses, including those for diabetic cataracts, to patient records in recent years to b...
NexThera, of Busan, South Korea, announced July 16 that it had filed an investigational new drug (IND) application with the US FDA for a Phase I/IIa trial of NT-101, an eye drop candidate for wet a...
Outlook Therapeutics announced July 8 that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had granted marketing authorization for Lytenava, an ophthalmic formulation of bevaciz...
The US FDA announced July 1 that it was expanding its TAP pilot program in October to include ophthalmic devices, as well as radiological health devices. The voluntary program, officially named the...
Genentech, a member of the Roche Group, announced July 5 that the US FDA had approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD...
Altos Biologics has submitted a marketing authorization application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept (Eylea) biosimilar, according to a joint announcement by Altos ...
Balance Ophthalmics has gained US FDA de novo classification for its FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system, a goggles and pump system designed to lower intraocular pressure (IOP) i...
German companies Formycon and Klinge Biopharma announced June 28 that the US FDA had approved their aflibercept (Eylea) biosimilar for wet age-related macular degeneration (AMD), diabetic macular e...
Swiss drugmaker Roche announced June 28 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended the extension of Vabysmo’s labeling to include tre...
Aurion Biotech announced June 19 that the US FDA had granted both breakthrough therapy and regenerative medicine advanced therapy status for AURN001, the company’s allogeneic cell therapy candidate...
Alcon reported June 24 that itsUnity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) had received US FDA 510(k) clearance. The company said it would be seeking real-world feedbac...
Nashville, Tennessee-based Harrow reported June 20 that it was moving closer to relaunching Triesence in 2024 after successfully achieving a production testing milestone. Triesence (triamcinolone a...
Neurotech Pharmaceuticals announced June 20 that the US FDA had accepted its biologic license application (BLA) and granted priority review for NT-501, an encapsulated cell therapy implant candidat...
Vyluma announced June 18 that it had met with the US FDA’s Division of Ophthalmology to discuss resubmitting its new drug application (NDA) for lead compound NVK002, a low-dose formulation of atrop...
4D Molecular Therapeutics announced June 24 that the US FDA had cleared its investigational new drug application for a Phase I clinical trial of 4D-175, an intravitreal gene therapy candidate targe...
The Centers for Medicare and Medicaid Services announced June 17 that funding it made available to health care providers under the Change Healthcare/Optum Payment Disruption (CHOPD) program would e...
Barbados-based Evolution Optiks announced June 4 that it had received 510(k) clearance from the US FDA for the LFR-260, its light field powered subjective tele-refractor. The device gained CE marki...
Alcon offered big discounts in China’s public sector centralized volume-based procurement (VBP) cycle for intraocular lenses (IOLs). The company’s low bids in seven of the eight bidding categories ...
Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...
Italy’s SIFI announced May 31 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of Akantior (polihexanide 0.08%) for the treatment...
The US FDA granted six clearances through the ophthalmic device division using the 510(k) pathway in May 2024, according to the agency’s database. Reichert gained market clearance for its new hand-...
Apellis Pharmaceuticals reported June 10 that Syfovre (pegcetacoplan injection), its treatment for geographic atrophy (GA), preserved visual function at 36 months in the GALE long-term extension st...
Bausch + Lomb announced May 28 that Health Canada had approved the enVista Envy trifocal intraocular lens (IOL). It’s the first approval for the new lens. The Envy was expected to be available in C...
Surgeons and ophthalmic societies worked together at open meetings in June to address five Medicare administrative contractors’ latest proposal to limit coverage of minimally invasive glaucoma surg...
Japan’s Nidek announced June 3 that it had launched the RS-1 Glauvas OCT system. The device is CE marked as a Class IIa device. Nidek said the RS-1 Glauvas’ streamlined workflow and advanced analyt...
WPS Insurance Corporation, a Medicare administrative contractor (MAC) in the US, has again proposed changing its coverage of cataract surgery after putting forth a similar proposal in September 202...
ARPA-H announced May 30 a program called UPGRADE, designed to eliminate cyberattacks on hospitals by developing tools that proactively probe digital hospital environments for software weaknesses. A...
Japan’s Nidek announced June 10 that it had received CE marking for the NP-1/NP-1C preloaded IOL injection system. The system is preloaded with the Aktis aspheric hydrophobic soft acrylic lens, whi...
Belite Bio announced June 12 that Japanese regulators had granted the Sakigake, or pioneer therapy, designation to its lead candidate, tinlarebant, an oral tablet targeting Stargardt disease. Belit...
Five Medicare administrative contractors have proposed new limits to their coverage of minimally invasive glaucoma surgery (MIGS). The move comes a year after the same MACs roiled the glaucoma subs...
Avirmax Biopharma announced May 30 that the US FDA had cleared its investigational new drug application for a Phase I/IIa clinical trial of its intravitreal gene therapy candidate targeting wet age...
Italy’s SIFI announced May 31 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of Akantior (polihexanide 0.08%) for the treatment...
Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...
Bausch + Lomb announced May 28 that Health Canada had approved the enVista Envy trifocal intraocular lens (IOL). It’s the first approval for the new lens. The Envy is expected to be available in Ca...
Santen has issued a voluntary recall and suspended shipment for all unexpired lots of its dry eye treatment Diquas LX in Japan due to issues with a preservative, Pharma Japan reported May 23. Sante...
Vyluma reported May 29 that the European Medicines Agency had accepted its marketing application for lead compound NVK002, a low-dose formulation of atropine targeting childhood myopia. NVK002 is a...
The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by B...
New World Medical reported May 22 that its Kahook Dual Blade Glide (KDB Glide) had gained US FDA 510(k) clearance. The KDB Glide was previously classified as a Class 1, 510(k)-exempt device. With t...
Drug Farm, of Shanghai, China, announced May 17 that the US FDA had cleared its investigational new drug (IND) application for a Phase Ib trial of its DF-003, an oral alpha kinase 1 (ALPK1) inhibit...
China’s Innovent Biologics announced May 20 that Chinese regulators had accepted the new drug application for IBI311, a recombinant anti-insulin-like growth factor 1 receptor antibody for thyroid e...
Notal Vision announced May 16 that the US FDA had granted de novo marketing authorization for its patient-operated Scanly home optical coherence tomography (OCT) device. The Scanly uses artificial ...
The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in April 2024, according to the agency’s database. Topcon received 510(k) clearance for its Maestro...
The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by B...
Taiwan-based Formosa Pharmaceuticals announced May 9 that it had entered into an exclusive licensing agreement with Tabuk Pharmaceuticals to market clobetasol propionate 0.05% eye drops for post-su...
Notal Vision announced May 16 that the US FDA had granted de novo marketing authorization for its patient-operated Scanly home optical coherence tomography (OCT) device. The Scanly uses artificial ...
Outlook Therapeutics announced May 13 that it had submitted a marketing authorization application to the UK’s Medicines and Healthcare Products Regulatory Agency for ONS-5010 (bevacizumab gamma) fo...
Aeye Health announced April 30 that the US FDA had approved the company’s autonomous artificial intelligence-aided screening technology for diabetic retinopathy (DR) using a hand-held retinal camer...
Bausch + Lomb announced April 26 that the US FDA had approved a preservative-free formulation of Lumify redness reliever eye drops. Lumify is an over-the-counter formulation of low-dose brimonidine...
China-headquartered Eluminex Biosciences announced April 30 that the US FDA had accepted its investigational new drug (IND) application for EB-105, a tri-specific fusion antibody candidate for diab...
Sweden’s Xbrane Biopharma announced April 21 that the US FDA had issued a complete response letter rejecting Xbrane’s ranibizumab biosimilar, branded in Europe as Ximluci. The company said regulato...
The US FDA granted three clearances through the ophthalmic device division using the 510(k) pathway in March 2024, according to the agency’s database. Cylite received clearance for its HP-OCT. The ...
Outlook Therapeutics announced March 22 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of ONS-5010 (L...
A US FDA official has expressed support for measures before Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion. It ca...
A nor’easter storm that disrupted many travel itineraries failed to deter the nearly 600 industry personnel and clinicians who attended Eyecelerator ahead of the 2024 ASCRS meeting. This year’s con...
Wiley Chambers, MD, an ophthalmologist who conducted or supervised the review of ophthalmic drugs at the US FDA for 36½ years, retired from the agency Jan. 13, 2024. The 65-year-old is now serving ...
BVI Medical announced April 17 that it had launched its Podeye hydrophobic monofocal IOL in Japan, following approval by the Japanese Pharmaceuticals and Medical Devices Agency. The lens was set to...
Nine large employers—including American Airlines, Aramark, General Motors, Target, and Lowe’s—have filed a new lawsuit against leading makers of generic drugs, claiming the drugmakers have engaged ...
The US Justice Department has accused New York-based Regeneron of fraudulently manipulating Medicare’s drug pricing process for Eylea, costing the Medicare system hundreds of millions of dollars. T...
Alexion, the rare disease unit of AstraZeneca, announced March 25 that the US FDA had approved its long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for adults with neuromyelitis opt...
A US FDA official has expressed support for measures before Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion. Under...
Nine large employers—including American Airlines, Aramark, General Motors, Target, and Lowe’s—have filed a new lawsuit against leading makers of generic drugs, claiming the drugmakers have engaged ...
The US Justice Department has accused New York-based Regeneron of fraudulently manipulating Medicare’s drug pricing process for Eylea, costing the Medicare system hundreds of millions of dollars. T...
Ocugen announced April 8 that the US FDA had cleared the company’s investigational new drug (IND) amendment to initiate a Phase III clinical trial of OCU400, a modifier gene therapy candidate for r...
Viatris and Ocuphire Pharma announced April 1 the US launch of Ryzumvi (phentolamine ophthalmic solution) 0.75% for the reversal of pharmacologically induced mydriasis. The US FDA approved Ryzumvi ...
The Centers for Medicare and Medicaid Services (CMS) has issued a J-code for Glaukos’ iDose. The billing code takes effect July 1, 2024. iDose TR gained US FDA approval under the 505(b)(2) pathway ...
Nanoscope Therapeutics on March 26 reported positive topline results from its two-year Phase IIb clinical trial of MCO-010, an ambient-light-activatable optogenetic monotherapy to restore vision in...
The US State Department announced March 27 that it was offering a reward of up to $10 million for information on ALPHV BlackCat-linked hackers targeting critical infrastructure in the US. The agenc...
Wiley Chambers, MD, an ophthalmologist who conducted or supervised the review of ophthalmic drugs at the US FDA for 36 1/2 years, retired from the agency Jan. 13, 2024. The 65-year-old is now servi...
Belite Bio announced March 22 that it had applied to Japan’s Pharmaceuticals and Medical Devices Agency for clearance to conduct a clinical trial of tinlarebant, its oral treatment candidate for St...
Alexion, the rare disease unit of AstraZeneca, announced March 25 that the US FDA had approved its long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for the treatment of adults with ...
Outlook Therapeutics announced March 22 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of ONS-5010 (L...
The Centers for Medicare and Medicaid Services (CMS) has issued J-codes for Regeneron’s Eylea HD and Astellas Pharma’s Izervay. The billing codes take effect April 1, 2024. Eylea HD (aflibercept) i...
Design Therapeutics reported March 19 in its 2023 financial statement that the US FDA had cleared its investigational new drug (IND) application for a clinical trial of DT-168 in Fuchs’ endothelial...
Taiwan-based Formosa Pharmaceuticals announced March 4 that the US FDA had approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for inflammation and pain following ocular surgery. ...
The Federal Trade Commission has sent notices to about 160 thousand individuals who received LASIK consultations at LasikPlus or Joffe MediCenter that they may be eligible for a settlement payout. ...
The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in February 2024, according to the agency’s database. CATS Tonometer received clearance for its ton...
India’s Brassica Pharma announced Feb. 12 that it was voluntarily recalling eye ointments sold by retailers such as Walmart and CVS due to a danger of infection. The company said an inspection by t...
South Dakota Gov. Kristi Noem on March 4 signed into law a measure expanding the scope of practice of optometrists in the state. HB 1099 allows doctors of optometry to administer injections around ...
Germany’s VSY Biotechnology launched its Enova Maestro trifocal toric preloaded intraocular lens (IOL) at the European Society of Cataract and Refractive Surgeons (ESCRS) Winter Meeting, held Feb. ...
Santen Pharmaceutical announced Feb. 28 that it had filed for marketing approval in Japan of DE-127 (0.025% atropine sulfate hydrate eye drop), designed to slow the progression of myopia. The produ...
US lawmakers passed a partial government funding bill on March 8 that included a provision mitigating cuts to Medicare physician reimbursement in effect since Jan. 1. The legislation changes the re...
South Dakota Gov. Kristi Noem on March 4 signed into law a measure expanding the scope of practice of optometrists in the state. HB 1099 allows doctors of optometry to administer injections around ...
Germany’s Formycon announced March 11 that FYB201 (ranibizumab), a biosimilar to Lucentis, had received marketing authorization from the Saudi Food & Drug Authority. Jordan’s MS Pharma is Formycon’...
Taiwan-based Formosa Pharmaceuticals announced March 4 that the US FDA had approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for inflammation and pain following ocular surgery. ...
The Federal Trade Commission has sent notices to about 160 thousand individuals who received LASIK consultations at LasikPlus or Joffe MediCenter that they may be eligible for a settlement payout. ...
Ireland-based Mallinckrodt announced March 1 that the US FDA had approved its supplemental new drug application (sNDA) for the H.P. Acthar Gel single-dose pre-filled SelfJect injector. SelfJect pro...
India’s Brassica Pharma announced Feb. 12 that it was voluntarily recalling eye ointments sold by retailers such as Walmart and CVS due to a danger of infection. The company said an inspection by t...
The US FDA issued a warning Jan. 31 to consumers not to purchase or use South Moon, Rebright, or FivFivGo eye drops because of the potential risk of eye infection. The products are copycats that ca...
Prime Minister Narendra Modi’s government has stepped up scrutiny of India’s pharmaceutical factories after being stung by a series of overseas deaths linked to Indian-made drugs. The news agency R...
The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in January 2024, according to the agency’s database. Meridian received clearance for three laser mo...
The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Jan. 17 that will limit the amount of time for certain payers to make prior authorization decisions. Payers will have 72 ...
Japan has removed the requirement that foreign drugmakers conduct a Phase I clinical trial in Japan before Japanese individuals participate in Phase III multiregional clinical trials (MRCT) for reg...
Attendees of the G360 New Horizons Forum received a detailed breakdown of the battle that the ophthalmic industry collectively waged throughout 2023 to stop proposed limits to Medicare coverage for...
Wisconsin Physician Services (WPS), a Medicare Administrative Contractor (MAC) in the US, has abandoned a proposal to require visual acuity of 20/50 or worse for cataract surgery to be medically ne...
Eyenovia, of New York, announced Feb. 13 that the company’s facility in Redwood City, California, had successfully completed US FDA inspection for approval as a commercial manufacturing facility. T...
Apellis Pharmaceuticals announced Jan. 26 that, as expected, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recom-mended refusal of the company’s marketin...
Amneal Pharmaceuticals announced Jan. 10 that it had received US FDA approval for and launched generic fluorometholone eye drops. The product is indicated for the treatment of corticosteroid-respon...
London’s Okyo Pharma announced Feb. 9 that the US FDA had cleared its investigational new drug (IND) application for topical candidate OK-101 in neuropathic corneal pain—a first for that indication...
Toku, of San Diego, California, announced Feb. 5 that it had obtained CE and UK Conformity Assessment (UKCA) marking for its patented CLAiR technology—AI-powered software that identifies elevated c...
The US FDA issued a warning Jan. 31 to consumers not to purchase or use South Moon, Rebright, or FivFivGo eye drops because of the potential risk of eye infection. The products are copycats that ca...
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