- Tags: diabetic retinopathy
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
Prevent Blindness launches diabetes and the eye advisory committee
In partnership with industry professionals, nonprofit seeks to increase awareness and early identification of diabetes-related eye diseases through three key initiatives.
Pipeline
FDA agrees to SPA for Ocular Therapeutix NPDR registrational trial
Agreement includes planned design for study evaluating AXPAXLI (formerly OTX-TIKI), an IVT implant with the potential for long-term durability and fewer injections.
Research
Study: ERG outperforms structural testing for DR risk assessment
Longitudinal research evaluates three forms of structural testing versus LKC Technologies’ RETeval in identifying high-risk patients for DR progression.
Research
New research identifies additional DR signs in the retina
Changes in the shape and branching patterns of retinal blood vessels—visible on OCT-A scans—may be indicators of early diabetic retinopathy.
Products
Optomed USA launches next-gen handheld fundus camera
MedTech company’s Optomed Lumo is a portable, non-mydriatic retinal camera designed for “flexibility and ease of use” in a variety of healthcare settings
Business
Harrow purchases US commercialization rights to Samsung Bioepis' biosimilar portfolio
Acquisition includes two major anti-VEGF therapies for retinal diseases: OPUVIZ and BYOOVIZ, generic equivalents to EYLEA and Lucentis, respectively.
Research
AOA report analyzes ocular risks of GLP-1RAs
Released during the 2025 Optometry’s Meeting, this comprehensive rundown dives into potential rare ophthalmic side effects associated with use—and offers clinical care recommendations.
Research
Earlier diabetes diagnosis may lead to worsening DR progression
Study identifies mechanisms for the potential protective effect of later diabetes diagnosis on DR severity.
Products
FDA approves Genentech's Susvimo for DR
First sustained-release delivery system of ranibizumab earns third indication, with injections needed just once every 9 months.
Research
Air pollution exposure leading to more ocular disease cases among adults
Myopic eyes demonstrated increased risk of ocular disease with exposure to air pollution.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