• Tags: AMD
FDA approves Lupin's Lucentis biosimilar injection
Products

FDA approves Lupin's Lucentis biosimilar injection

Ranluspec (ranibizumab-hkdz) marks the third ranibizumab biosimilar cleared in the U.S. to treat five retinal indications.
Outlook resubmits wet AMD BLA for bevacizumab after FDA appeal win
Pipeline

Outlook resubmits wet AMD BLA for bevacizumab after FDA appeal win

Marks fourth attempt to secure approval for the potential first on-label bevacizumab product specifically formulated for IVT retinal use in the US.
Outlook Therapeutics wins FDA appeal for wet AMD BLA
Pipeline

Outlook Therapeutics wins FDA appeal for wet AMD BLA

Decision follows company’s challenge to its third rejected package of ONS-5010 / LYTENAVA (bevacizumab-vikg); fourth submission expected in June.
Neuvasq highlights novel antibody approach for restoring blood-retina barrier in wet AMD and DME
Research

Neuvasq highlights novel antibody approach for restoring blood-retina barrier in wet AMD and DME

Preclinical data of NVQ401 and NVQ501 demonstrate improvements in BRB integrity and function in vascular retinopathy models.
Lineage reports positive 36-month findings on GA cell therapy
Pipeline

Lineage reports positive 36-month findings on GA cell therapy

Results from the phase 1/2a trial of OpRegen demonstrate sustained BCVA and structural improvements.
PreserVision AREDS3 launch highlights B vitamins’ potential role in AMD
Research

PreserVision AREDS3 launch highlights B vitamins’ potential role in AMD

Bausch + Lomb advanced PreserVision formula spotlights the unique B-vitamin complex in reducing the risk for AMD, especially in earlier stages.
Nutritional supplementation is redefining eye health management
Events

Nutritional supplementation is redefining eye health management

Highlights from Bausch + Lomb’s first-ever consumer summit.
Merck kicks off phase 2b/3 trial on tri-specific antibody for wet AMD
Pipeline

Merck kicks off phase 2b/3 trial on tri-specific antibody for wet AMD

Merck initiates next phase of clinical testing in ophthalmology with two candidates targeting nAMD and DME.
Retina Summit 2026: OD updates for AMD management and imaging
Events

Retina Summit 2026: OD updates for AMD management and imaging

Key takeaways from AAO’s one-day meeting explore retina care’s shift from referral-based to decision-making at the OD level.
Ocular Therapeutix releases additional phase 3 AXPAXLI data for wet AMD
Pipeline

Ocular Therapeutix releases additional phase 3 AXPAXLI data for wet AMD

Data from SOL-1 phase 3 data will become the basis of a planned NDA submission in near future.
Does smoking age your eyes?
Research

Does smoking age your eyes?

Mouse model study finds cigarette smoke may cause changes in eye cells similar to aging damage, with younger and older cells differing in protection.
FDA accepts Outlook Therapeutics' request over rejected wet AMD BLA
Pipeline

FDA accepts Outlook Therapeutics' request over rejected wet AMD BLA

Company challenges decision on failed third submission package of ONS-5010 / LYTENAVA (bevacizumab-vikg), with a decision expected in May.
i-Lumen Scientific earns FDA IDE clearance for dry AMD trial
Pipeline

i-Lumen Scientific earns FDA IDE clearance for dry AMD trial

Biotech company is expanding the global i-SIGHT 2 pivotal trial evaluating its non-invasive bioelectric stimulation therapy as an in-office treatment.
FDA approves expanded EYLEA HD dosing intervals
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FDA approves expanded EYLEA HD dosing intervals

VEGF inhibitor cleared for every 20 weeks among wet AMD and DME patients; clearance based on 96-week data from the PHOTON and PULSAR pivotal trials.
Eyedaptic launches latest version of AI-based smart glasses for AMD
Products

Eyedaptic launches latest version of AI-based smart glasses for AMD

Designed for patients with retinal diseases, the EYE7 is an integrated wearable solution with real-time vision enhancements and a new visual assistant.
Study urges alternative tracking for wet AMD poor responders
Research

Study urges alternative tracking for wet AMD poor responders

Structural change tracking indicates subretinal fibrosis may drive vision loss, calling for a shift in patient monitoring.
EyePoint begins dosing in phase 3 DME trials for DURAVYU
Pipeline

EyePoint begins dosing in phase 3 DME trials for DURAVYU

COMO and CAPRI pivotal studies are evaluating vorolanib insert when intravitreally-injected every 6 months; topline data expected H2 2027.
Ocular Therapeutix reports positive phase 3 SOL-1 superiority data for wet AMD
Pipeline

Ocular Therapeutix reports positive phase 3 SOL-1 superiority data for wet AMD

AXPAXLI is the first and only novel drug to demonstrate superiority to an approved anti-VEGF treatment in an FDA-aligned wet AMD study.
4DMT completes enrollment for phase 3 wet AMD gene therapy trial
Pipeline

4DMT completes enrollment for phase 3 wet AMD gene therapy trial

4FRONT-1 study is evaluating 4D-150 as a single, low-dose IVT injection among treatment-naïve wet AMD patients; topline data expected in H1 2027.
Reducing chronic inflammation minimizes AMD-linked vision loss
Research

Reducing chronic inflammation minimizes AMD-linked vision loss

Mouse model demonstrates role of NLRP3 in AMD pathology and highlights potential therapeutic approaches.