- Tags: diabetic retinopathy
Research
Myopia may delay DR development and progression
Study used Mendelian randomization to identify a causal relationship between myopia and diabetic retinopathy.
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.
Research
Study: DR, DME patients most likely to miss follow-up care
Multiple demographic and socioeconomic factors identified in association with loss to follow-up care in patients with PDR and DME.
Products
FDA approves Celltrion's Eylea bisoimilar
EYDENZELT (aflibercept-bvoa) is indicated for patients with wet AMD, macular edema following RVO, DME, and DR.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