- Tags: AMD
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
Lower AMD risk tied to long-term metformin use
Study joins growing body of research on the protective effect of metformin against AMD risk in diabetic patients.
Products
FDA approves Celltrion's Eylea bisoimilar
EYDENZELT (aflibercept-bvoa) is indicated for patients with wet AMD, macular edema following RVO, DME, and DR.
Business
Ollin Biosciences debuts with next-gen ophthalmic pipeline
Biotech launches with $100 million financing and a lead program addressing wet AMD and DME via a higher potency VEGF/Ang2 bispecific antibody.
Legal
Regeneron settles with Sandoz over Eylea biosimilar patent infringement lawsuit
Agreement enables FDA-approved Enzeevu (aflibercept-abzv) to launch in Q4 2026, or potentially earlier.
Research
What factors impact visual acuity in intermediate AMD?
Study identifies three key features that impact visual acuity in patients with intermediate AMD.
Business
Alcon officially purchases LumiThera
Acquisition of the Valeda Light Delivery System includes plans to expand commercial market availability in 2026.
Pipeline
Outlook Therapeutics receives second FDA CRL over wet AMD BLA
Agency rejects submission of bevacizumab-vikg for a second time, citing a single issue with the application: a lack of effectiveness data.
Research
Are blue light-filtering IOLs beneficial for AMD?
Blue light-filtering IOLs demonstrate no protective effect on the risk of developing exudative AMD.Pipeline
FDA extends review period for EYLEA HD expanded labeling
Delay follows a recent site inspection; proposed expansion includes a new indication, updated dosings for current indications, and a pre-filled syringe version.
Research
Study links gout patients with increased AMD risk and progression
Activation of similar inflammatory pathways may explain the observed association.
Research
Genentech reports 5-year results on SUSVIMO for wet AMD
Presented at ASRS, new data reinforce the ranibizumab injection’s ability to provide an immediate and predictable durability as an alternative to regular eye injections.
Pipeline
4DMT releases 60-week phase 2 analysis on wet AMD gene therapy
Reported at ASRS, data supports sustained vision gains and a 78% reduction in supplemental injections for 4D-150’s highest dose as company preps for phase 3 trial.
Products
Altris AI launches new app for direct OCT syncing
Altris Sync software syncs directly to OCT devices from eight leading manufacturers, enabling automated OCT file uploading and eliminating the need for manual operation.
Business