- Tags: 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.
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
Advanced AMD linked to imbalanced gut microbiome
Though seemingly unrelated, gut flora may play a surprising role in the pathogenesis of age-related macular degeneration (AMD).
Products
Regeneron receives FDA CRL, delaying Eylea HD sBLA approval
Company plans to resubmit app for pre-filled syringe version in early 2026, noting two 2025 dates to watch for.
Business
Lilly to purchase Adverum Biotechnologies
With a Q4 closing date in mind, acquisition supports ongoing clinical trials and development activities for Ixo-vec, a one-time IVT gene therapy injection to treat wet AMD.
Research
Atopic dermatitis linked to increased risk for AMD
Study highlights importance of monitoring adult patients with atopic dermatitis for signs of AMD.
Pipeline
Complement Therapeutics' GA gene therapy IND receives FDA clearance
Clearance gives green light to begin Q1 2026 patient enrollment for the Opti-GAIN study evaluating CTx001 as a one-time, durable treatment.
Research