- Tags: diabetic retinopathy
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
FDA accepts Regeneron's EYLEA HD sBLA for priority review
Agency sets target action date of Aug. 19 to consider a new indication for macular edema following RVO and expanded monthly dosing.
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
Hormones may play key role in DR risk among diabetes patients
Surprising findings reveal how sex hormones may secretly influence the risk for diabetic retinopathy.
Business
AAO adds ERG to preferred practice guidelines for DR
Gold standard for clinical decision-making promotes electroretinography, enabling earlier intervention and personalized care.
Pipeline
Kodiak Sciences concludes enrollment for phase 3 DR on tarcocimab
Anti-VEGF tarcocimab tedromer is under clinical investigation as a mainstay IVT monotherapy with twice-yearly dosing for three retinal indications.
Research
Earlier PPV may benefit vitrectomy among PDR patients
Early PPV associated with improved visual outcomes and fewer severe complications.
Pipeline
Opus Genetics and FDA agree on SPA for phase 3 NPDR gene therapy trial
Study’s newly-established primary endpoint will support a potential new drug application submission of APX3300 for market approval.
Business
Avant Technologies and Ainnova to advance low-cost retinal camera with AI software
Newly-formed joint company will develop an exclusive retinal imaging camera to be integrated into Ainnova’s disease detection digital platform.
Research
Cholesterol medication may also reduce DR risk
LENS trial evaluated the cholesterol medication fenofibrate’s potential ability to slow DR.
Products
Eyedaptic introduces AI-powered smart glasses for AMD
Next-gen device features interactive, generative visual assistant with a built-in camera and hands-free capabilities.
Research
Prevalence of DR is increasing among diabetics, minorities
New study identifies trends in type 1 and type 2 diabetic retinopathy prevalence.
Research
Topcon and Orbis partner to expand DR screenings in sub-Saharan Africa
Collaboration utilizes robotic fundus imaging cameras and an AI-based platform that deliver results in mere seconds for Rwanda patients.
Products
SUSVIMO phase 3 data supports sustained efficacy for DR, DME
FDA has also accepted Genentech’s sBLA for the sustained-release drug delivery system’s diabetic eye disease indications.
Research
AAO, NANOS respond to study on semaglutide-NAION connection
Recent research identified substantial risk for NAION development among diabetic and obese patients using the GLP-1 RA.
Research
Semaglutide for diabetes tied to increased NAION risk
Mass Eye and Ear researchers identify higher incidence among patients taking popular weight loss and Type 2 diabetes drug.
Products
FDA approves EYLEA biosimilar for serious retinal diseases
Formycon reports the generic biosimilar demonstrates a comparable efficacy, safety, pharmacokinetics, and immunogenicity to Regeneron’s aflibercept.
Pipeline
Ocular Therapeutix releases positive NPDR phase 1 data, plans for wet AMD repeat dosing study
Updates follow company’s decision to cut 13% of workforce in order to focus on the clinical development of axitinib intravitreal implant.
Research
AAO validates teleretinal screening for effective DR detection
Teleretinal screening shown to be an accurate and cost-effective approach to DR screening.
Products