- Tags: AMD
Research
Study connects HDL levels to AMD development
Key finding: A U-shaped relationship between low and high HDL and increased risk of AMD.
Products
FDA declines Regeneron's EYLEA HD sBLA for extended dosing
Request was for additional extended dosing interval > every 16 weeks; agency makes no mention of request for new indication of macular edema following RVO.
Products
Settlement paves way for US commercialization of Eylea biosimilar
Biocon Biologic’s YESAFILI (aflibercept-jbvf) now expected to launch in H2 2026 after dismissal of Regeneron’s patent infringement lawsuits.
Research
Do you need to treat subretinal fluid in AMD?
Review outlines a proposed algorithm for evaluating subretinal fluid in nAMD patients.
Business
Opthea to cut workforce by an estimated 65%
Significant layoffs follow in wake of the company's phase 3 trial failures and subsequent termination of its wet AMD program late last month.
Pipeline
FDA accepts Outlook Therapeutics' bevacizumab BLA for wet AMD
With a PDUFA date of Aug. 27, ONS-5010 (LYTENAVA) could become the first FDA-approved bevacizumab formulation targeting this retinal disease.
Research
Chronic stress linked to increased AMD risk
Study joins a growing body of evidence that chronic stress is an important risk factor for ocular diseases.
Business
Character Biosciences raises $93M to advance genetics-based AMD therapeutics
Financing will support precision medicine candidates as part of its integrated patient data platform and AI-based analytics engine.
Pipeline
Opthea terminates wet AMD program for sozinibercept
Days after phase 3 COAST trial fails primary goal, company releases expedited ShORe trial findings on anti-VEGF trap agent.
Pipeline
Opthea fails primary goal in phase 3 wet AMD on sozinibercept
Combination therapy of sozinibercept and aflibercept 2.0 mg did not achieve a mean change in BCVA from baseline to week 52; company explains next steps.
Research
Could GLP-1 receptor agonists reduce AMD risk?
GLP-1 receptor agonists demonstrate a notable effect on the risk of non-exudative AMD.
Pipeline
Luxa Biotechnology releases FIH data on RPE cell therapy for dry AMD
Stem cell-based replacement therapy shows potential with substantial BCVA gains in worse-seeing and reversal of disease trajectory in better-seeing patients.
Pipeline
Clearside Biomedical reports phase 3 plans for SCS wet AMD therapy
Announcement follows company’s end-of-phase 2 meeting with FDA to discuss next steps for CLS-AX (axitinib injectable suspension).
Research
Do omega-3s and DHA actually reduce AMD risk?
An increase in plasma omega-3 was associated with a significant decrease in AMD incidence.
Pipeline
Positive 52-week data supports 4DMT's wet AMD gene therapy
PRISM trial extension cohort finds 4D-150 continues to be well tolerated after 3 years of follow-up; phase 3 program initiation to begin this year.
Products
FDA approves updated label for IZERVAY to treat GA
Astellas’s avacincaptad pegol now has no limitation on its dosing duration, enabling longer-term administration for patients with GA secondary to AMD.
Pipeline
Extended phase 3 study reports 3-year durability of EYLEA HD for wet AMD
Regeneron reports the majority of patients maintained visual and anatomic outcomes while achieving extended dosing regiments—including those switching from aflibercept 2 mg.
Pipeline
Clearside Biomedical reports phase 2b analyses of CLS-AX for wet AMD
Data from two sub-groups to determine design of two phase 3 clinical trials evaluating the use of axitinb injectable suspension with the SCS Microinjector.
Research
New research supports efficacy of AI in home OCT monitoring
Cross-sectional study results led to the first-ever clearance of an AI algorithm applied to OCT images: Notal Vision’s SCANLY Home OCT.
Products