- Tags: AMD
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.
Products
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.
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.
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.
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.
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.
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.
Research
Reducing chronic inflammation minimizes AMD-linked vision loss
Mouse model demonstrates role of NLRP3 in AMD pathology and highlights potential therapeutic approaches.
Research
First real-world data shows early promise of high-dose aflibercept for wet AMD
Eight-week findings from the SPECTRUM observational study indicate a safety profile consistent with prior evaluations.
Pipeline
Complement Therapeutics secures Fast Track Designation for lead GA therapy
AAV-based CTx001 modulates multiple pathways of the complement system when delivered as a one-time, subretinal injection.
Pipeline
Aviceda releases phase 2b topline data on AVD-104 for GA
Latest SIGLEC trial results show both dosing arms with 31% to 38% less lesion growth than prior trials; phase 3 plans are underway.
Pipeline
FDA rejects Outlook Therapeutics' third BLA submission of bevacizumab for wet AMD
Agency cites need for confirmatory evidence of efficacy as reason for latest CRL; ONS-5010 is already approved in the EU and UK as LYTENAVA.
Pipeline
Ocular Therapeutix plans for NDA submission of AXPAXLI for wet AMD
Company expects to submit package in Q1 2026, following the anticipated release of positive 1-year data from the phase 3 SOL-1 trial.
Pipeline
SeaBeLife and Unither to formulate and develop retinal degenerative disorder formulation
Collaboration focuses on accelerating development of SBL03, formulated for topical delivery to target retinal cell necrosis in GA and dry AMD.
Research
Lifestyle behaviors play major role in preventing genetic risk for advanced AMD
Study assesses if lifestyle behaviors can offset the risk of AMD progression in those with high genetic susceptibility.
Pipeline
Coave Therapeutics debuts lead SCS gene therapy for retinal vascular diseases
In-office, suprachoroidal delivery of CoTx-101 offers potential for durable and long-lasting vision gains in treating wet AMD and DME.
Research
New 5-year Syfovre data indicates extended delay of GA progression
GALE extension study findings show delayed GA lesion growth by an estimated 1.5 years in patients receiving continuous treatment.
Business
LambdaVision raises $7M to advance space-based artificial retina
Biotech is using space and microgravity to produce its protein-based artificial retina, designed to restore vision in retinal degenerative diseased patients.
Pipeline
Outlook Therapeutics resubmits wet AMD BLA for bevacizumab
Company’s third submission of ONS-5010 (bevacizumab-vikg) reportedly addresses prior issues raised in the FDA’s company response letter.
Research