Select US FDA Approvals and Clearances in March 2026
The US FDA’s ophthalmic device division granted clearance to three devices using the 510(k) pathway in March 2026, according to the agency’s database. Oculus received clearance for its Pentacam Cor...
PDUFA Dates for Ophthalmic Drug Candidates, April 2026
The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.
Incremental Improvements are the Trend in Vitrectomy Systems
New retinal surgical device offerings from manufacturers feature innovative fluidics systems and stiffer small-gauge instruments. Manufacturers hope the improvements they bring to vitrectomy surger...
Bausch + Lomb Launches Preloaded enVista Envy Trifocal IOL in Europe
Bausch + Lomb announced April 7 the commercial availability in Europe of the enVista Envy trifocal intraocular lens (IOL), preloaded in the EyeGility lens delivery system. Luc Bonnefoy, president o...
New Hampshire Governor Vetoes Bill to Allow ODs to Perform SLT, LPI, YAG Capsulotomy
New Hampshire Gov. Kelly Ayotte on March 27 vetoed House Bill 349, which would have expanded the scope of practice for optometrists in the state, allowing them to perform selective laser trabeculop...
First Human Cataract Surgery Performed with ForSight’s Robotic Aid
Israel’s ForSight Robotics announced April 7 that the first cataract surgery in a human patient had been performed with its Jasper robot-assisted surgical platform. The procedure was performed on a...
2026-2027 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.
J&J Continues to Reduce JLABS Footprint with Exit from New York
Johnson & Johnson is stepping away from its JLABS incubator site in New York, reducing its JLABS locations in the US to those in San Diego, San Francisco, and Boston. The New York site opened in 20...
Life Bio Leads Latest Fundraising with $80 Million in Series D Round
Life Biosciences led recent ophthalmic fundraising efforts with $80 million in Series D funding to advance its cell rejuvenation therapy pipeline. Financing announced in the past four weeks totaled...
Tenpoint Launches Yuvezzi Drops for Presbyopia in US
Tenpoint Therapeutics announced March 30 that it had launched Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) for presbyopia in the US. Tenpoint, with offices in London,...
Clinical Trial Updates for Ophthalmic Candidates, April 2026
Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.
Meeting-Related Launches Include Range of Ophthalmic Products
Several ophthalmic companies launched products at the 2026 annual meeting of the American Society of Cataract and Refractive Surgery, held April 10-13 in Washington, DC. Market Scope will be coveri...
Emerging Companies Pursuing Ophthalmic Indications, April 2026
Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.
Weekly Poll of MDs, US and Western Europe, April 2026
Meira GTx Pays J&J $25 Million to Buy Back Gene Therapy Candidate for XLRP
MeiraGTx announced April 16 that it would reacquire all interests in bota-vec, a gene therapy candidate it developed targeting X-linked retinitis pigmentosa (XLRP), from Johnson & Johnson. MeiraGTx...
April 2026 Ophthalmic News Briefs
Swiss ophthalmic diagnostics company Haag-Streit announced March 31 the global launch of its Metis 3D Digital Heads-Up Module (Metis HU). The system was launched in the US in October 2025. Metis HU...
MeiraGTx Pays J&J $25 Million to Buy Back Gene Therapy Candidate for XLRP
MeiraGTx announced April 16 that it would reacquire all interests in bota-vec, a gene therapy candidate it developed targeting X-linked retinitis pigmentosa (XLRP), from Johnson & Johnson. MeiraGTx...
J&J Reports Q1-2026 Surgical Vision Revenue of $396 Million
Johnson & Johnson reported April 14 that its Q1-2026 global surgical vision revenue totaled $396 million, a 9.7 percent increase over $361 million in Q1-2025. Q1-2026 surgical vision revenue in the...
KC Pharmaceuticals Recalls 3.1 Million Eye Drop Bottles over Sterility Concerns
The US FDA reported in March that more than 3.1 million bottles of over-the-counter eye drops sold at major US retailers—including CVS, Walgreens, Kroger, and Rite Aid—had been recalled over steril...
Pioneering Eye Charities Team Up to Provide Cataract Surgery in Rwanda, Laos
Cure Blindness Project and The Fred Hollows Foundation reported April 2 that they are partnering to end avoidable blindness in Rwanda and Laos by 2035. In addition, they will address the cataract s...
Oculus Launches Pentacam Cornea OCT in US
German company Oculus announced April 8 that it had launched its Pentacam Cornea OCT in the US. The device gained US 510(k) clearance in March 2026. The platform creates Scheimpflug images simultan...
Bausch + Lomb Gains US FDA Clearance for Bi-Blade+ Cutter and Adaptive Fluidics Update
Bausch + Lomb announced April 8 that the US FDA had granted 510(k) clearance for the Bi-Blade+ dual-port cutter and Adaptive Fluidics update for the Stellaris Elite dual-function cataract and vitre...
Halma Acquires Surgistar to Augment MST’s Ophthalmic Instrument Portfolio
UK-based Halma, the parent of ophthalmic instrument maker MicroSurgical Technology (MST) announced April 13 that it had acquired Surgistar, of Vista, California, as an add-on to MST. No financial d...
Lumibird to Acquire Malaysian Distributor, Establish Southeast Asian Hub
French company Lumibird announced April 8 that it had signed an agreement to acquire its long-term distribution partner Biz Medic, of Kuala Lumpur, Malaysia. The company said, however, that it was ...
Nordic Pharma Now Includes Cannulas with Lacrifill, Marks US Milestone
Dutch drugmaker Nordic Pharma announced April 9 that it is now shipping cannulas along with its syringes of its Lacrifill canalicular gel for dry eye. The company said it made the move in response ...
US FDA Grants Orphan Drug Status to Drug Farm’s ROSAH Candidate
Drug Farm, of Shanghai, China, announced March 26 that the US FDA had granted orphan drug status to DF-003, an oral alpha kinase 1 (ALPK1) inhibitor targeting the rare genetic disease ROSAH syndrom...
US FDA Grants Orphan Drug Status to SignaBlok’s ROP Candidate
SignaBlok, of Shrewsbury, Massachusetts, announced March 26 that the US FDA had granted orphan drug status to its TREM-1 peptide inhibitor targeting retinopathy of prematurity (ROP). Orphan drug de...
EMA Grants PRIME Designation to Oculis’ Privosegtor for Optic Neuritis
Swiss company Oculisannounced March 31 that the European Medicines Agency had granted Priority Medicines (PRIME) designation to Privosegtor, its treatment candidate for optic neuritis. The PRIME de...
US FDA Grants RMAT Status to Ray Therapeutics’ Optogenetic RP Candidate
Ray Therapeutics announced April 1 that the US FDA had granted regenerative medicine advanced therapy (RMAT) designation to RTx-015, its optogenetic therapy candidate for retinitis pigmentosa (RP)....
Alcon Launches Clareon TruPlus Enhanced Monofocal IOL at ASCRS 2026
Alcon announced the US launch of the Clareon TruPlus enhanced monofocal intraocular lens (IOL), along with a toric version, at the 2026 meeting of the American Society of Cataract and Refractive Su...
US FDA Approves Eylea HD for Extended Dosing Intervals up to 5 Months
Regeneron announced April 2 that the US FDA had approved the extension of dosing intervals for Eylea HD (aflibercept 8 mg) up to every 20 weeks for patients with wet age-related macular degeneratio...
Bausch + Lomb Launches Preloaded enVista Envy Trifocal IOL in Europe
Bausch + Lomb announced April 7 the commercial availability in Europe of the enVista Envy trifocal intraocular lens (IOL), preloaded in the EyeGility lens delivery system. Luc Bonnefoy, president o...
STAAR Surgical Reports Preliminary Q1-2026 Net Sales of More Than $90 Million
STAAR Surgical, of Lake Forest, California, reported April 8 that its Q1-2026 net sales were expected to be inexcess of $90 million, compared with $42.6 million in Q1-2025. STAAR’s Q1-2024 revenue ...
First Human Cataract Surgery Performed with ForSight’s Robotic Aid
Israel’s ForSight Robotics announced April 7 that the first cataract surgery in a human patient had been performed with its Jasper robot-assisted surgical platform. The procedure was performed on a...
Haag-Streit Announces Global Launch of Metis 3D Digital Heads-Up Module
Swiss ophthalmic diagnostics company Haag-Streit announced March 31 the global launch of its Metis 3D Digital Heads-Up Module (Metis HU). A US launch occurred in October 2025 at the American Academ...
Cellution Launches OptiCover Amniotic Graft at ASCRS Meeting
Cellution Biologics launched its OptiCover amniotic graft for ocular use at the 2026 meeting of the American Society of Cataract and Refractive Surgery (ASCRS), which ran April 10-13 in Washington,...
US FDA Gives Green Light to Trial of i-Lumen’s Bioelectric Stimulation Device for Dry AMD
i-Lumen Scientific announced March 31 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a pivotal trial of its bioelectri...
Lenstec Appoints Blake Michaels as Chief Executive Officer
Lenstec announced on LinkedIn April 6 that it had appointed Blake Michaels as its new chief executive officer. Lenstec, of St. Petersburg, Florida, markets ClearView and Softec intraocular lenses (...
Tenpoint Appoints Stephen S. Lane, MD, as Chief Medical Officer
Tenpoint Therapeutics announced April 7 that it had appointed Stephen S. Lane, MD, as chief medical officer (CMO). Most recently, Lane was CMO and head of medical safety at Alcon. He is a past pres...
Biogen to Acquire Apellis for $5.6 Billion with Eye Toward Growth
Biogen reported March 31 that it had agreed to acquire Apellis Pharmaceuticals, maker of Syfovre, for about $5.6 billion in cash to expand its portfolio of rare-disease medicines. Under the deal, ...
Tenpoint Launches Yuvezzi Drops for Presbyopia in US
Tenpoint Therapeutics announced March 30 that it had launched Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) for presbyopia in the US. Tenpoint, with offices in London,...
New Hampshire Governor Vetoes Bill to Allow ODs to Perform SLT, LPI, YAG Capsulotomy
New Hampshire Gov. Kelly Ayotte on March 27 vetoed House Bill 349, which would have expanded the scope of practice for optometrists in the state, allowing them to perform selective laser trabeculop...
Lensar Reports 2025 Revenue of $58.4 Million
Lensar, of Orlando, Florida, reported March 31 that its 2025 revenue was $58.4 million, a 9 percent increase over $53.5 million in 2024. Lensar noted that 79 percent of its 2025 revenue came from r...
China Gaining on US for Leadership in Early-Stage Drug Development, Georgetown Researchers Report
Early-stage drug development has increased dramatically over the past decade, with China gaining the most ground and challenging the US for leadership, according to Georgetown University. Georgetow...
VirtuaLens IOL Simulator Now Includes Monovision Feature
VirtuaLens, of Austin, Texas, reported March 23 that its intraocular lens (IOL) simulator now offers a monovision feature. The wireless VR headset is designed to help patients understand their opti...
Health Canada Approves Clobetasol Propionate Eye Drops for Postsurgical Pain, Inflammation
Canada’s Apotex announced March 25 that regulators there had approved Clobivis (clobetasol propionate ophthalmic suspension, 0.05%) for the treatment of postoperative inflammation and pain followin...
US FDA Gives Green Light to Trial of Long Bridge’s Prosthetic Capsular Bag
Long Bridge Medical announced March 26 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a pivotal trial of LensOne, its ...
Biocon Appoints Shreehas Tambe as CEO, Managing Director
India’s Biocon Limited announced March 27 that it had appointed Shreehas Tambe as its chief executive officer and managing director, effective April 1. The company said Tambe joined Biocon nearly t...
Cencora to Acquire EyeSouth Partners’ Retina Business for $1.1 Billion
Cencora announced March 23 that it had agreed to acquire the retina business of EyeSouth Partners for $1.1 billion. The move follows Cencora’s $4.6 billion deal in January 2025 to buy Retina Consul...
Regulators in China Approve Lotilaner Drops, Triggering $15 Million Payment to Tarsus
Tarsus Pharmaceuticals announced March 23 that regulators in China had approved TP-03 (lotilaner ophthalmic solution) 0.25%, its mite-killing treatment targeting Demodex blepharitis that is markete...
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