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
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...
ViaLase Gains CE Marking for Femtosecond Laser for Glaucoma Treatment
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...
Physician With Blepharospasm Fights MACs’ Proposed Limits on Botulinum Toxin Injections
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...
August 2024 Ophthalmic News Briefs
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...
US FDA Approves Aflibercept (Eylea) Biosimilar from Sandoz
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 Submits NDA to US FDA for LNZ100 Presbyopia Drop Candidate
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...
US FDA Approves Generic Prednisolone Acetate Drops from India’s Lupin for Ocular Inflammation
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 Gains CPT Code to Report Retinal PBM Therapy, a Step Toward Reimbursement
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...
US FDA Approves Expanded Access Program for Ocugen’s RP Candidate
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...
Physician With Blepharospasm Fights MACs’ Proposed Limits on Botulinum Toxin Injections
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...
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...
ViaLase Gains CE Marking for Femtosecond Laser for Glaucoma Treatment
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...
Roche’s Vabysmo Gains EU Approval for Third Indication—RVO
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...
Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye
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...
US FDA Grants Rare Pediatric Drug Status to Theriva’s Retinoblastoma Candidate
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 Receives US FDA’s RMAT Designation for Ixo-vec in Wet AMD
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...
Advisory Panel Recommends Orphan Drug Status for SIFI’s Polihexanide in Fungal Keratitis
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...
IOP-Lowering Goggles Developed by John Berdahl, MD, Gain De Novo Certification for Marketing
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...
Select US FDA Approvals and Clearances in June 2024
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 ...
Ophthalmic Devices to be Included in FDA TAP Accelerator Program
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...
Medicare Advantage Insurers Make Millions Off Ophthalmic Diagnoses They Add to Patient Records, WSJ Reports
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...
US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, and RVO Indications
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...
July 2024 Ophthalmic News Briefs
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...
Medicare Advantage Insurers Make Millions Off Ophthalmic Diagnoses They Add to Patient Records, WSJ Reports
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 Files IND with US FDA for Trial of Wet AMD Eye Drop Candidate
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...
UK Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
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...
Ophthalmic Devices to be Included in FDA TAP Program
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...
US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, RVO
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 Files for European Approval of Aflibercept (Eylea) Biosimilar
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 ...
IOP-Lowering Goggles Developed by John Berdahl, MD, Gain De Novo Nod for Marketing
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...
US FDA Approves Aflibercept (Eylea) Biosimilar from Formycon, Klinge
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...
Roche’s Vabysmo Gains Positive CHMP Opinion in EU for Third Indication—RVO
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...
US FDA Grants Breakthrough, Regenerative Medicine Status to Aurion’s Corneal Cell Therapy Candidate
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 Gains US FDA 510(k) Clearance for Unity VCS and CS Systems
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...
Harrow Looks to Relaunch Triesence in 2024, as Production Testing Continues
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...
US FDA Accepts BLA for Neurotech’s MacTel Candidate, Grants Priority Review
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 Plans to Resubmit NDA for Low-Dose Atropine for Myopia after Meeting with US FDA
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...
US FDA Gives Green Light to Trial of 4DMT’s Gene Therapy Candidate for GA
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...
CMS Winding Down Funding Program to Address Change Healthcare Cyberattack
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...
Evolution Optiks Receives US FDA 510(k) Clearance for Tele-refactor
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...
Volume-Based Procurement Could Upend China’s IOL Market
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 ...
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
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...
SIFI’s Acanthamoeba Keratitis Eye Drop Candidate Gains Positive CHMP Opinion
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...
Select US FDA Approvals and Clearances in May 2024
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 Reports Syfovre Preserved Visual Function at 36 Months in Extension Study
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 Receives Health Canada Approval for EnVista Envy Trifocal IOL
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, Societies Respond to MACs’ New Proposed MIGS Limits
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...
June 2024 Ophthalmic News Briefs
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 MAC Revisits Changing Coverage for Cataract Surgery
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 Launches UPGRADE to Strengthen Hospitals’ Cybersecurity
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...
Nidek Gains CE Marking for Preloaded IOL Injector System
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 Receives Sakigake (Pioneer Drug) Nod in Japan for Tinlarebant in Stargardt
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...
MACs Propose New Limits on MIGS Procedures
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...
US FDA Gives Green Light to Trial of Avirmax’ Gene Therapy Candidate for Wet AMD with PCV
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...
Acanthamoeba Keratitis Eye Drop Candidate from SIFI Gains Positive CHMP Opinion
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...
EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
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 Receives Health Canada Approval for EnVista Envy Trifocal IOL
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 Recalls All Unexpired Lots of Diquas LX Over Issues with Preservative
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...
EU Accepts Vyluma’s Marketing Application for Low-Dose Atropine in Childhood Myopia
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...
US FDA Approves First Interchangeable Biosimilars to Eylea
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 Gains US 510(k) Clearance for KDB Glide
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...
US FDA Gives Green Light to Phase Ib Trial of Drug Farm’s Oral ALPK1 Inhibitor in ROSAH Patients
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...
Chinese Regulators Accept NDA from Innovent for IBI311 in Thyroid Eye Disease
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...
US FDA Grants De Novo Authorization to Notal Vision’s Scanly AI-Powered Home OCT
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 ...
Select US FDA Approvals and Clearances in April 2023
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...
US FDA Approves First Interchangeable Biosimilars to Eylea
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...
May 2024 Ophthalmic News Briefs
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...
US FDA Grants De Novo Marketing Authorization to Notal Vision’s Scanly AI-Powered Home OCT
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 Submits UK Marketing Application for Ophthalmic Bevacizumab in Wet AMD
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...
US FDA Approves Aeye’s Autonomous AI DR Screening with Hand-held Fundus Camera
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...
US FDA Approves Preservative-Free Lumify Drops from Bausch + Lomb
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...
US FDA Accepts IND for Eluminex’ Tri-specific Antibody Candidate for DME
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...
US FDA Rejects Xbrane’s Ranibizumab Biosimilar, Citing Analysis and Manufacturing Issues
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...
Select US FDA Approvals and Clearances in March 2024
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 ...
Ophthalmic Bevacizumab Candidate from Outlook Gains Positive CHMP Opinion
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...
US FDA Backs Call to Eliminate Interchangeability Designation for Biosimilars
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...
Eyecelerator Celebrates Fourth Anniversary While Showcasing Innovation in Ophthalmology
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...
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