Latest Industry News & Trends

US FDA Approves Expanded Label for Izervay to Extend Treatment for GA Beyond 12 Months

Japan’s Astellas Pharma announced Feb. 12 that the US FDA had approved expanded labeling for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy (GA), extending the allowed du...

2024 and Quarterly Ophthalmic Revenue Roundup for Regeneron, Carl Zeiss Meditec, Hoya, and STAAR

Regeneron, of Tarrytown, New York, reported Feb. 4 that its 2024 US revenue for Eylea 2 mg (aflibercept 2 mg) and Eylea HD (aflibercept 8 mg) totaled nearly $5.97 billion, a 1 percent increase over...

EssilorLuxottica Acquires Canadian Retinal Camera Maker Cellview Imaging

Eyewear conglomerate EssilorLuxottica announced Feb. 11 that it had acquired Cellview Imaging, a Canadian startup specializing in ultra-widefield retinal diagnostics. Cellview’s WRI-1 fundus camera...

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...

2024 Ophthalmic Revenue Roundup for Roche, AbbVie, Novartis

Swiss company Roche reported Jan. 29 that global sales of Vabysmo for 2024 were CHF 3.86 billion ($4.25 billion, converted Jan. 29, 2025), a 63.6 percent increase (+68 percent cc) over CHF 2.36 bil...

US FDA Approves Genentech’s Susvimo Refillable Implant for DME

Genentech, a member of the Roche Group, announced Feb. 4 that the US FDA had approved Susvimo, a refillable ranibizumab implant, for diabetic macular edema (DME). The company said Susvimo is now av...

Australian Regulators Approve Apellis’ Syfovre for Geographic Atrophy

Apellis Pharmaceuticals announced Jan. 27 that Australia’s Therapeutic Goods Administration had approved Syfovre (intravitreal pegcetacoplan) for the every-other-month treatment of adult patients w...

Harrow, Cencora Partner to Improve Drug Access for Retina Specialists, Patients

Drugmaker Harrow reported Jan. 27 that it had partnered with Cencora to launch a program called “Harrow Cares,” with the goal of making Harrow products iHeezo and Triesence more accessible and affo...

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 ...

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...

Retrospective Study Finds Link Between IVT Injections, Cataract Surgery Complications

Researchers from the Byers Eye Institute at Stanford Health Care in Palo Alto, California, have found that cataractpatients with prior intravitreal (IVT) injections face more complications after ca...

US FDA Grants Rare Pediatric Designation to MeiraGTx’ LCA1 Gene Therapy Candidate

MeiraGTx, with offices in London and New York, announced Jan. 22 that the US FDA had granted rare pediatric disease designation to its AAV8-RK-RetGC gene therapy candidate for Leber congenital amau...

US FDA Grants Fast Track Status to Nacuity’s Oral RP Candidate

Nacuity Pharmaceuticals announced Jan. 21 that the US FDA had granted fast track designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s oral retinitis pigmentosa (RP) treatment candidat...

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...

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 ...

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.

Aviceda Leads Latest Ophthalmic Fundraising with $207.5 Million Round

Aviceda Therapeutics led recent ophthalmic fundraising efforts with an upsized $207.5 million Series C financing round to support its trials in geographic atrophy. Financing announced in the past f...

2024 in Review: Corporate and Surgeon Rankings of Top 10 Stories

Market Scope asked industry participants and surgeons to select the top story for 2024. Below are their choices. Zeiss’ Rollout of Micor 700 Shakes Up Cataract Equipment Market in US MAC Turmoil Sh...

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: Flurry of Eylea Biosimilars Approved; Most Blocked in US by Lawsuits

The FDA was in a hurry in 2024 to get low-cost competitors to Eylea into the US market. Regeneron wasn’t. The FDA approved 12 drugs for ophthalmic indications in 2024, including four generic glauco...

2024 in Review: Complement Therapies for GA Fall Short in Bid for Approval in EU

Apellis Pharmaceuticals and Astellas Pharma were unable to build on their regulatory wins in the US to get a victory in Europe. The European Medicines Agency’s Committee for Medicinal Products for ...

Clinical Trial Updates for Ophthalmic Candidates, January 2025

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

EssilorLuxottica to Acquire Ophthalmic Device Maker Espansione Group

Eyewear conglomerate EssilorLuxottica announced Dec. 16 that it had entered into an agreement to acquire Espansione Group, an Italian maker of light-based ophthalmic devices. Financial details and ...

Children’s Hospital Los Angeles Celebrates 100th Luxturna Procedure

Children’s Hospital Los Angeles (CHLA) marked a milestone recently, completing its 100th procedure with the retinal gene therapy Luxturna for Leber congenital amaurosis (LCA)—the most of any center...

2025-2026 Ophthalmic Meetings Calendar

Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.

Emerging Companies Pursuing Ophthalmic Indications, January 2025

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

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...

Bausch + Lomb Moves to Acquire Whitecap, InflammX to Expand Clinical Pipeline

Bausch + Lomb recently made moves to acquire two companies that it says will strengthen its expanding pipeline and help address unmet needs in ophthalmology. The company announced Jan. 13 that an a...

Dual Inflammasome Inhibiting Implant Shows Positive Phase I/II Results in GA

Inflammasome Therapeutics reported on Jan. 15 positive topline three-month data from a Phase I/II trial of its K8 dual inflammasome inhibiting implant in geographic atrophy (GA). In the study of fi...

Study Shows Promise for Genetic Base Editing in Stargardt Disease

Researchers from Switzerland’s Institute of Molecular and Clinical Ophthalmology Basel and Beam Therapeutics say they have developed a gene editing therapy that could potentially treat Stargardt di...

Bausch + Lomb to Collaborate with Character Bio, City Therapeutics in AMD, GA

Bausch + Lomb recently made deals to collaborate with two companies that it says will bolster its expanding pipeline and help address unmet needs in ophthalmology. Character Biosciences reported on...

Teva Signs Deal to Commercialize Formycon’s Aflibercept Biosimilar Candidate in Israel and Most of Europe

Israel’s Teva Pharmaceuticals announced Jan. 13 that it had entered into a collaboration with German companies Klinge Biopharma and Formycon for the semi-exclusive commercialization of FYB203, Form...

Valo Health Suspends Work on Oral DR Candidate After Phase II Trial Misses Endpoints

Valo Health reported Dec. 31 that OPL-0401, its oral diabetic retinopathy treatment candidate, missed its primary and secondary endpoints of improvement in Diabetic Retinopathy Severity Scale score...

Aviceda Raises $207.5 Million in Upsized Series C Round to Advance GA Candidate

Aviceda Therapeutics announced Jan. 7 that it had raised $207.5 million in an upsized Series C funding round. The Cambridge, Massachusetts, company said proceeds would support an ongoing Phase IIb/...

US FDA Grants Rare Pediatric Disease Designation to ViGeneron’s RP Gene Therapy Candidate

Germany’s ViGeneron announced Jan. 8 that the US FDA had granted rare pediatric disease designation to VG901, a gene therapy candidate targeting retinitis pigmentosa (RP) caused by mutations in the...

Eyenuk Appoints Gaurav Agarwal as Chief Executive Officer

Digital health care company Eyenuk, of Los Angeles, California, announced Jan. 6 that it had appointed Gaurav Agarwal as chief executive officer. Agarwal was previously the head of product and cust...

Unity Biotechnology Appoints Federico Grossi, MD, PhD, as Chief Medical Officer

Unity Biotechnology announced Jan. 6 that it had appointed Federico Grossi, MD, PhD, as chief medical officer. Grossi was most recently chief medical officer at Apellis Pharmaceuticals, where he he...

Xbrane Resubmits BLA to US FDA for Ranibizumab Biosimilar

Sweden’s Xbrane Biopharma announced Dec. 31 that it had resubmitted the biologics license application (BLA) to the US FDA for its Lucentis (ranibizumab) biosimilar candidate. The FDA issued a compl...

Ophthalmic Revenue Roundup for Carl Zeiss Meditec, Amgen, Biogen

Carl Zeiss Meditec reported Dec. 11 that ophthalmology revenue for its full fiscal year 2023/2024, which ended Sept. 30, was €1.59 billion (US $1.7 billion, converted Dec. 11, 2024), an increase of...

ViGeneron Gains US FDA Green Light to Begin Phase I/II Trial of Gene Therapy Candidate for Stargardt

Germany’s ViGeneron announced Dec. 18 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II study of VG801, a gene therapy candidate to treat Stargardt disease...

EssilorLuxottica to Acquire Espansione Group, Maker of Ophthalmic Devices

Eyewear conglomerate EssilorLuxottica announced Dec. 16 that it had entered into an agreement to acquire Espansione Group, an Italian maker of light-based ophthalmic devices. Financial details and ...

SightStream is Developing an Eye Drop Candidate for Corneal Endothelial Disease

SightStream Biotherapeutics, an ophthalmic drug development company spun out of Harvard University in 2020, is raising $7.5 million in Series A funding to advance its preclinical melanocortin recep...

Children’s Hospital Los Angeles Celebrates 100th Luxturna Procedure

Children’s Hospital Los Angeles (CHLA) marked a milestone recently, completing its 100th procedure with the retinal gene therapy Luxturna for Leber congenital amaurosis (LCA)—the most of any center...

US FDA Grants Rare Pediatric Disease Designation to EyeDNA’s RP Gene Therapy Candidate

France’s eyeDNA Therapeutics announced Dec. 17 that the US FDA had granted rare pediatric disease designation for HORA-PDE6b, its gene therapy candidate for PDE6b-associated retinitis pigmentosa (R...

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), ...

NIH Joins Push to Fund Breakthroughs in Oculomics

The National Institutes of Health (NIH) is joining the push to fund the development of technologies and biomarkers to diagnose systemic disease through the eye, a field known as oculomics. The NIH ...

$2.3 Million NIH Grant Furthers U. of Oklahoma Research into Retinopathy of Prematurity

A University of Oklahoma neonatologist has earned a five-year, $2.3 million grant from the National Institutes of Health (NIH) to further her studies on retinopathy of prematurity (ROP). Faizah Bha...

Scripps Research Includes AMD Among its Regenerative Medicine Targets

Scientists at Scripps Research and its nonprofit drug development arm, the Calibr-Skaggs Institute for Innovative Medicines, are advancing novel regenerative medicines capable of repairing tissues ...

Acelyrin’s Izokibep Misses Endpoints in Phase IIb/III Uveitis Trial

Acelyrin reported Dec. 10 that izokibep, an inhibitor of interleukin-17A, missed its endpoints in a Phase IIb/III trial in non-infectious, non-anterior uveitis. The company said it would drop izoki...

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...

Ophthalmologists Report 5.5 Percent Increase in Q3-2024 Procedure Volume

US ophthalmologists reported that ophthalmic procedures increased 5.5 percent in Q3-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...

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.

NIH Joins Push to Fund Breakthroughs in Oculomics Diagnostic Tech

The National Institutes of Health (NIH) is joining the push to fund the development of technologies and biomarkers to diagnose systemic disease through the eye, a field known as oculomics. The NIH ...

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...

Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million

Clearside Biomedical’s Asia-Pacific partner, Arctic Vision, announced Nov. 7 that it had licensed Chinese commercialization rights for ARVN001, marketed in the US as Xipere, to Santen Pharmaceutica...

Clinical Trial Updates for Ophthalmic Candidates, December 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Lineage Leads Latest Ophthalmic Fundraising with $66 Million Offering

Lineage Cell Therapeutics led recent ophthalmic fundraising efforts with a registered direct offering worth up to $66 million to advance its RPE cell therapy candidate. Financing announced in the p...

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...

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...

Emerging Companies Pursuing Ophthalmic Indications, December 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

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...

Kyung-Ah Kim, PhD, Named President, CEO of Samsung Bioepis

South Korea’s Samsung Bioepis announced Nov. 27 that Kyung-Ah Kim, PhD, has been appointed president and chief executive officer. Kim had been serving as executive vice president and development di...

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...

Avant, Ainnova Advancing Low-Cost Retinal Camera with AI Screening Software

Nevada-based Avant Technologies and Ainnova Tech, of Houston, Texas, announced Nov. 20 that the two companies would advance Ainnova’s proprietary low-cost retinal camera packaged with the Vision AI...

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...

Atsena Licenses LCA1 Gene Therapy Candidate to Nippon Shinyaku for US, Japan

Atsena Therapeutics announced Nov. 13 that it had granted exclusive commercial rights for its Leber congenital amaurosis type 1 (LCA1) gene therapy candidate ATSN-101 to Nippon Shinyaku in the US a...

US FDA Grants Rare Pediatric, Fast Track Status to Alkeus’ Stargardt Candidate

Alkeus Pharmaceuticals announced Nov. 18 that the US FDA had granted rare pediatric disease and fast track designations to gildeuretinol (ALK-001), its oral therapy candidate for Stargardt disease....

CMS Cuts Ophthalmologists’ Procedure Fees, While Raising ASC, HOPD Facility Fees

The Centers for Medicare and Medicaid Services (CMS) published on Nov. 1 the final schedule of Medicare reimbursement fees for physicians in 2025. It also released its facility fee payments for ASC...

Amgen Launches Eylea Biosimilar Pavblu After Court Win Over Regeneron

Amgen has launched its Eylea biosimilar, Pavblu (aflibercept-ayyh), after a victory in October in its patent fight with Regeneron. Fierce Pharma reported that a trio of US circuit judges on Oct. 22...

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...

MeiraGTx to Submit UK Marketing Application for LCA4 Candidate Under ‘Exceptional Circumstances’

MeiraGTx, with offices in London and New York, announced Nov. 13 that it would submit a marketing authorization application in the UK under “exceptional circumstances” for AAV-AIPL1, its gene thera...

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-...

Gene Therapies Make Progress Toward Goal of Restoring Sight

Gene therapies again generated buzz at the 2024 AAO meeting—as they have at recent meetings—but perhaps most exciting were reports of a treatment that could partially restore severe vision loss fro...

Kalaris Will Merge with AlloVir and Advance Candidate for Exudative Retinal Disease

Kalaris Therapeutics announced Nov. 8 that it would merge with biotech company AlloVir in an all-stock transaction to advance Kalaris’ next-generation anti-VEGF candidate TH103 for exudative retina...

Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million

Clearside Biomedical’s Asia-Pacific partner, Arctic Vision, announced Nov. 7 that it had licensed Chinese commercialization rights for ARVN001, marketed in the US as Xipere, to Santen Pharmaceutica...

US FDA Grants Fast Track Designation to Feliqs’ ROP Candidate

Japanese biopharmaceutical company Feliqs announced Nov. 1 that the US FDA had granted its lead asset, FLQ-101, fast track designation for the prevention of retinopathy of prematurity (ROP). FLQ-10...

Ophthalmology Continues to Draw Investors, Eyecelerator Meeting Shows; Retina Stands Out

Ophthalmology remains an appealing investment, driven largely by procedural growth. While hundreds of companies are working toward technology enhancements and innovative therapies, ophthalmology pr...

Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients

Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...

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...

EyePoint Leads Latest Ophthalmic Fundraising with $161 Million Public Offering

EyePoint Pharmaceuticals led recent ophthalmic fundraising efforts with a $161 million upsized underwritten public offering. Proceeds in part will fund clinical development of Duravyu. Financing an...

The New Opus Genetics Charts a Course to Gene Therapy Approval

Ben Yerxa, PhD, and George Magrath, MD, say they have a way out of the jungle in which ocular gene therapy development has been trapped since the US FDA approved Luxturna in 2017. “You have to be r...

Are Drugs for GA in the ‘Trough of Disillusionment’?

The celebrations and excitement that accompanied the launch in 2023 of the first two drugs approved in the US for the treatment geographic atrophy (GA) gave way to a hangover and regrets at the 202...

Weighing the Ophthalmic Impact of Boom in GLP-1 Receptor Agonist Treatment

Recent studies indicate that up to 6 percent of the US population is currently taking a GLP-1 receptor agonist, a class of drugs prescribed to help manage blood glucose levels for diabetes and weig...

Alcon Looks to Refine Retinal Surgery with Unifeye, Unipexy

Alcon launched at the 2024 AAO meeting two new retinal surgical devices—Unifeye for air-gas exchange and Unipexy for retinopexy. Each is a one-person, hand-held, single-use gas delivery device. The...

Clinical Trial Updates for Ophthalmic Candidates, November 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Pine Stops Compounding IVT Avastin, Creating Concerns Over Shortage

Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...

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...

US FDA Grants De Novo Classification to LumiThera’s Photobiomodulation System for Dry AMD

LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobiomodulation system for treatment of patients with dry age-related macul...

Q3-2024 Ophthalmic Revenue Roundup for AbbVie, Apellis, Glaukos, STAAR, and Lensar

AbbVie, of North Chicago, Illinois, reported Oct. 30 that its Q3-2024 eye care net revenue was $525 million, a 13.5 percent decline (-11.2 percent cc) from $605 million in Q3-2023. Restasis revenue...

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) ...

Q3-2024 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Novartis

Regeneron of Tarrytown, New York, reported Oct. 31 that its Q3-2024 US revenue for Eylea (aflibercept) 2 mg and Eylea HD (a higher dose of aflibercept at 8 mg) was $1.54 billion, a 3 percent increa...

Vabysmo Improved Vision in Underrepresented Populations with DME in Elevatum Study

Genentech, a member of the Roche Group, announced Oct. 18 positive topline one-year results from the postmarket Elevatum study evaluating Vabysmo (faricimab-svoa) for the treatment of diabetic macu...

Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III

Alkeus Pharmaceuticals reported positive topline results on Oct. 23 from the Phase III SAGA trial of gildeuretinol acetate (ALK-001), a once-daily oral therapy candidate targeting geographic atroph...

RevOpsis Awarded $1.8 Million NEI Grant to Advance Retinal Candidate RO-104

RevOpsis Therapeutics announced Oct. 15 that it had been awarded a Small Business Innovation Research grant of $1.8 million from the National Eye Institute (NEI) to advance lead asset RO-104 for ex...

Korean Companies GC Biopharma, Novelty Nobility to Collaborate on GA Drug Discovery

South Korean companies GC Biopharma and Novelty Nobility announced Oct. 28 that they would jointly research and develop a novel treatment candidate for geographic atrophy (GA). The companies said a...

Pine Pharmaceuticals Stops Compounding IVT Avastin, Creating Concerns Over Shortage

Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...

Q3-2024 Ophthalmic Revenue Roundup for Roche and J&J Vision

Swiss company Roche reported Oct. 23 that Q3-2024 Vabysmo sales were CHF 1 billion ($1.15 billion, converted on Oct. 23, 2024), a 59 percent increase over CHF 656 million in Q3-2023. The company sa...

Ocuphire Pharma Acquires Opus Genetics, Will Operate Under Opus Name

Ocuphire Pharma announced Oct. 22 that it would acquire Opus Genetics in an all-stock transaction. The combined company will operate under the Opus name and will trade on the Nasdaq under the ticke...

Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients

Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...

Eyenuk, AAO Collaborate to Offer AI-Driven DR Screening for Underserved Patients in Delaware

Eyenuk and the American Academy of Ophthalmology (AAO) reported Oct. 16 that they had teamed up under the AAO’s EyeCare America program to provide eye disease screening for underserved communities ...

EU Regulators Rain on Apellis’ Party at 2024 Euretina Congress

The big news at the 24th Euretina congress was something that didn’t happen at the congress. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) embarrassed Apelli...

Orasis Leads Latest Ophthalmic Deals with $78 Million Financing

Orasis Pharmaceuticals led recent ophthalmic fundraising efforts with $78 million in Series D and structured capital to support the launch of Qlosi drops for presbyopia. Financing announced in the ...

Emerging Companies Pursuing Ophthalmic Indications, October 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Retina Specialists Grapple with Functional Endpoints in Clinical Trials

European regulators’ repeated rejection of Syfovre made one thing very clear to retina specialists at Euretina: “Treatment should have an impact on everyday function,” said Thomas Ach, MD (Germany)...

Retina Surgeons at European Meetings Ask, ‘What’s New?’

Experienced retina surgeons among the approximately 8.1 thousand attendees at Euretina in Barcelona, Spain, were underwhelmed by the surgical devices that industry had on display. “There is nothing...

First GA Therapies at Crossroads as EU Regulators Unconvinced Benefits Outweigh Risks

The negative opinion of Syfovre by a key EU regulatory committee has thrown the global marketing plans for complement inhibitors for GA into disarray. Two companies—Apellis Pharmaceuticals and Aste...

Clinical Trial Updates for Ophthalmic Candidates, October 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Harrow to Add Nearly 150 Jobs as it Expands in Nashville, Relaunches Triesence

Harrow reported Sept. 25 that it is creating nearly 150 new jobs as it expands its corporate headquarters in Nashville, Tennessee. The move follows the company increasing its total leased space in ...

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 ...

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...

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...

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...

Iridex Appoints Patrick Mercer as Chief Executive Officer

Iridex reported Oct. 3 that it had appointed Patrick Mercer as chief executive officer, to go along with his role as president, effective Oct. 1. Mercer had also served as the company’s chief opera...

Opthea Appoints Parisa Zamiri, MD, PhD, as Chief Medical Officer

Australian drug developer Opthea announced Oct. 8 that it had appointed Parisa Zamiri, MD, PhD, as chief medical officer. Zamiri, an ophthalmologist, has clinical experience in medical retina, immu...

Oak Hill Bio Promotes Josh Distler, JD, to Chief Executive Officer

Oak Hill Bio, of Cambridge, Massachusetts, announced Oct. 7 that it had promoted Josh Distler, JD, to chief executive officer. Distler is a co-founder of Oak Hill and previously served as the compa...

Harrow Relaunches Triesence Ophthalmic Corticosteroid in US

Nashville, Tennessee-based Harrow reported Oct. 3 that it had relaunchedTriesence (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative‑free synthetic corticosteroid, in the US. ...

Boehringer Ingelheim to Advance Surrozen’s Bi-specific Antibody in Retinal Disease

Surrozen announced Sept. 24 that development partner Boehringer Ingelheim will advance SZN-413, a bi-specific antibody targeting retinal vascular disease. The milestone triggers a $10 million payme...

Switzerland’s Rejuveron Life Sciences Rebrands as Centenara Labs

Switzerland’s Rejuveron Life Sciences announced Sept. 19 that it had rebranded as Centenara Labs. The company develops and invests in therapeutic candidates to promote healthy aging. Centenara said...

Nanoscope Licenses Optogenetic Technology from Max Planck Innovation

Nanoscope Therapeutics announced Sept. 30 that it had acquired a license for CatCh optogenetic technology from Max Planck Innovation, the technology transfer arm of the Max Planck Society. Financia...

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...

Eyconis Appoints Mark J. Bachleda, PharmD, MBA, as CEO

Eyconis announced Sept. 19 that it had appointed Mark J. Bachleda, PharmD, MBA, as chief executive officer and a member of its board of directors. Bachleda has served in executive leadership roles ...

Luxa Biotechnology Appoints Keith Dionne, PhD, as CEO

Luxa Biotechnology announced Oct. 1 that it had appointed Keith Dionne, PhD, as chief executive officer. Luxa, of Fort Lee, New Jersey, is advancing RPESC-RPE-4W, a cell product derived from adult ...

Nicox, Glaukos Sign Research and Option Agreement for Glaucoma Candidate

France’s Nicox announced Sept. 23 that it had signed an exclusive research and license option agreement with Glaukos for NCX 1728, Nicox’s novel nitric oxide (NO)-donating phosphodiesterase-5 (PDE5...

Amgen’s Pavblu is Fifth Aflibercept Biosimilar to Gain US Approval in 2024

The FDA has approved Amgen’s Pavblu (aflibercept-ayyh), making it the fifth Eylea biosimilar to reach the milestone in the US in 2024. FDA records show Pavblu was approved Aug. 23. Labeling shows i...

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 ...

Microsurgical Technology (MST) to Commercialize Vista Vitrectomy Products

Microsurgical Technology (MST) announced Sept. 17 that it had partnered with Vista Ophthalmics to commercialize Vista’s products—the Vista 1-Step vitrectomy probe and the Vista IS for maintaining t...

AAVantgarde Bio Appoints Jayashree Sahni, MD, as Chief Medical Officer

Italy’s AAVantgarde Bio announced Sept. 9 that it had appointed Jayashree Sahni, MD, FRCOphth, EMBA, as chief medical officer. Sahni, a retina specialist, was senior global program clinical head at...

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 ...

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...

Ophthalmic Company Revenue Up 2.6 Percent; Several Public Firms Report Record-High Quarters

Ophthalmic manufacturer revenue in Q2-2024 totaled $11.7 billion. Revenue increased 2.6 percent from the same quarter in 2023 and increased 5.9 percent from Q1-2024. The total includes Market Scope...

Ophthalmologists Report 0.5 Percent Increase in Q2-2024 Procedure Volume

US ophthalmologists reported that ophthalmic procedures increased 0.5 percent in Q2-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...

New Drugs for Exudative Retinal Disease Lift Companies Over Patent Cliffs

Roche faced an ophthalmic patent cliff in the US before Regeneron. First, Roche introduced an extended duration alternative to its flagship inhibitor of vascular endothelial growth factor (anti-VEG...

ONL Leads Latest Ophthalmic Fundraising with $65M Series D Round

ONL Therapeutics led recent ophthalmic fundraising efforts with a $65 million Series D round to continue advancing its small-molecule Fas inhibitor for retinal disease. Financing announced in the p...

Revenio’s iCare Subsidiary Acquires AI Screening Company Thirona Retina

Finland’s Revenio Group announced Aug. 20 that its iCare subsidiary had assumed ownership of the Dutch artificial intelligence (AI) software company Thirona Retina. iCare had made a minority invest...

OcuDyne Reports Positive Pilot Study Results Using Ophthalmic Artery Angioplasty in GA

OcuDyne, of Brooklyn Park, Minnesota, reported Sept. 9 that it had successfully completed a pilot study using its Optic System to perform ophthalmic artery angioplasty in patients with geographic a...

Emerging Companies Pursuing Ophthalmic Indications, September 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Light Control May Prevent Eye Damage in Premature Infants, Study Shows

A study in mice at the Science of Light Center at Cincinnati Children’s shows that lighting conditions can change how newborn eyes develop, with darkness fostering the development of more rods, the...

Clinical Trial Updates for Ophthalmic Candidates, September 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

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 ...

OcuDyne Reports Positive Pilot Study Results Using Ophthalmic Artery Angioplasty in GA

OcuDyne, of Brooklyn Park, Minnesota, reported Sept. 9 that it had successfully completed a pilot study using its Optic System to perform ophthalmic artery angioplasty in patients with geographic a...

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...

Belite Bio Appoints Hendrik P.N. Scholl, MD, MA, as Chief Medical Officer

Belite Bio announced Sept. 1 that it had appointed Hendrik P.N. Scholl, MD, MA, as chief medical officer, effective immediately. Scholl specializes in inherited retinal and macular dystrophies, and...

BioCryst Appoints Donald Fong, MD, as Chief Medical Officer

BioCryst Pharmaceuticals, of Durham, North Carolina, announced Sept. 5 that it had appointed Donald S. Fong, MD, MPH, as the company’s new chief medical officer, effective immediately. Fong joined ...

Light Control May Prevent Eye Damage in Premature Infants, Study Shows

A study in mice at the Science of Light Center at Cincinnati Children’s shows that lighting conditions can change how newborn eyes develop, with darkness fostering the development of more rods, the...

Tern Therapeutics Launches with $15 Million Financing and Pipeline in CLN2 Batten Disease 

Tern Therapeutics announced its launch Aug. 27, along with closing of a $15 million financing. The company also reported that it had licensed gene therapy candidates RGX-381 and RGX-181 (now design...

Visionix Unveils its VX 610 Automated Fundus Camera

Visionix USA has announced the launch of its VX 610 non-mydriatic automated fundus camera. The VX 610 boasts a range of automated features, including auto alignment, auto focus, and auto capture, w...

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...

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...

Revenio’s iCare Subsidiary Acquires AI Screening Company Thirona Retina

Finland’s Revenio Group announced Aug. 20 that its iCare subsidiary had assumed ownership of the Dutch artificial intelligence (AI) software company Thirona Retina. iCare had made a minority invest...

SriniVas Sadda, MD, Named Doheny Endowed Chair, Capping Year of New Roles

The Doheny Eye Institute announced Aug. 14 that SriniVas Sadda, MD, had been named the A. Ray Irvine Jr., MD, Endowed Chair. He also was recently named president of the Association for Research in ...

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...

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...

SalioGen Therapeutics Appoints Kali Stasi, MD, PhD, as Chief Medical Officer

SalioGen Therapeutics announced Aug. 19 that it had appointed Kalliopi “Kali” Stasi, MD, PhD, as chief medical officer. SalioGen said Stasi will be responsible for bringing the company’s SGT-1001, ...

Wnt Agonists and Optogenetics Create Excitement at 2024 ASRS Meeting in Sweden

Impressive new science and challenging business conditions topped the discussions at the American Society of Retina Specialists’ 2024 annual meeting. The conference took place July 17-20 in Stockho...

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...

MeiraGTx Leads Latest Ophthalmic Fundraising with $50 Million Offering

MeiraGTx led recent ophthalmic fundraising efforts with a $50 million offering of ordinary shares as it moves forward with its extensive pipeline of gene therapy candidates. Financing announced in ...

Clinical Trial Updates for Ophthalmic Candidates, August 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Emerging Companies Pursuing Ophthalmic Indications, August 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

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...

Q2-2024 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec, Amgen, STAAR, Astellas, Immunocore, Tarsus, Biogen, Lensar, and Iridex

AbbVie, of North Chicago, Illinois, reported July 25 that Q2-2024 net revenue for its eye care products totaled $533 million, a 13.3 percent decline (-10.9 percent cc) from $617 million in Q2-2023....

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 ...

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...

Q2-2024 Ophthalmic Revenue Roundup for Hoya, Harrow, RxSight, Sight Sciences, Ocular Therapeutix, and EyePoint

Japan-based Hoya Corporation announced Aug. 1 that its medical care segment (IOLs, endoscopes, artificial bone) had revenue for the quarter ending June 30, 2024—the first quarter of its fiscal year...

Mallinckrodt Announces Availability of Acthar Gel SelfJect Injector in the US

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 (sNDA...

Q2-2024 Ophthalmic Revenue Roundup for Regeneron, Roche, Bausch + Lomb, Novartis, and Four Others

Regeneron, of Tarrytown, New York, reported Aug. 1 that its Q2-2024 US revenue for Eylea was $1.53 billion, a 2 percent increase from $1.5 billion in Q2-2023. Eylea HD accounted for $304 million of...

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...

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...

Samsara Says First SING IMT for AMD Has Been Implanted in China

Samsara Vision, of Far Hills, New Jersey, announced July 22 that the first SING IMT procedure for age-related macular degeneration (AMD) had been completed in China. The SING IMT, which stands for ...

Beacon Appoints Lance Baldo, MD, as Chief Executive Officer

Beacon Therapeutics announced July 24 that it had named Lance Baldo, MD, as chief executive officer, effective Aug. 12, 2024. Most recently, Baldo served as chief medical officer at Freenome, an ea...

Beacon Leads Latest Ophthalmic Fundraising with $170 Million in Series B

Beacon Therapeutics led recent ophthalmic fundraising efforts with $170 million in Series B funding to advance its candidates for retinal disease. Financing announced in the past four weeks totaled...

Emerging Companies Pursuing Ophthalmic Indications, July 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Clinical Trial Updates for Ophthalmic Candidates, July 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Genentech to Reintroduce Susvimo for Wet AMD, Ending Voluntary Recall

Genentech, a member of the Roche Group, announced July 8 that it was reintroducing Susvimo, a refillable ranibizumab intravitreal implant for wet age-related macular degeneration (AMD) in the US, e...

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...

Weekly Surgeon Poll, July 2024

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...

Beacon Will Evaluate Abeona’s AAV204 Capsid for Select Ophthalmic Indications

Beacon Therapeutics will evaluate Abeona Therapeutics’ patented AAV204 capsid for potential gene therapies for select ophthalmic indications, the companies announced July 11. AAV204, a novel AAV ca...

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...