- Tags: DME
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.
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.
Research
Cost-effective HIV drug may improve vision in DME patients
Lamivudine shows potential as standalone and adjunctive therapy for DME patients.
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.
Business
Therini Bio raises nearly $40M to study DME and Alzheimer's immunotherapeutics
Funding to support two trials on fibrin-targeting immunotherapies targeting vascular dysfunction-induced neuroinflammation in severe retinal and neurological diseases.
Pipeline
FDA grants RMAT designation to 4DMT for DME gene therapy
4D-150 provides a multi-year sustained delivery of anti-VEGF from the retina via a single, low-dose IVT delivery—potentially reducing the need for frequent bolus injections.
Pipeline
Phase 3 enrollment concludes for Oculis' DME eye drop program
Topline data readout expected Q2 2026 as lead candidate OCS-01 has the potential to become the first noninvasive eye drop indicated to treat this retinal disease.
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.
Products
FDA approves expanded label of ILUVIEN for chronic posterior uveitis
Updated label for sustained-release fluocinolone acetonide intravitreal implant now includes noninfectious uveitis affecting the posterior segment of the eye.
Research
DME risk may decrease with use of GLP-1 agonists and fenofibrates
Diabetic patients taking calcium channel blockers demonstrated the opposite effect.
Pipeline
EyePoint releases positive 6-month data from phase 2 DME trial
DURAVYU (vorolanib intravitreal insert) 2.7 mg dose demonstrates early and sustained BCVA improvements plus extended time to first supplemental injection versus aflibercept.
Products
FDA approves Genentech's Susvimo for DME
The first sustained-release delivery system of ranibizumab secures its second indication for retinal disease, requiring as few as two injections per year.
Business
Bausch + Lomb may be acquiring InflammX Therapeutics
Option agreement indicates B+L intends to purchase the biotech company and its orally-administered therapeutic under clinical investigation for retinal diseases.
Business
Regeneron reportedly purchases British biotech Oxular
Announcement made by CEO seemingly confirms acquisition of the retinal disease company and its lead candidate: OXU-001, a sustained-release dexamethasone formulation for DME.
Research
Study proposes new severity scale for diabetic macular ischemia
Researchers developed the DMI severity scale by measuring capillary nonperfusion in OCT-A imaging.
Research
OCT-A determines DME treatment response to alternative therapies
Higher vascular density in the superficial and deep capillary plexuses correlated with good outcomes on ranibizumab.
Pipeline
Genentech reports phase 4 Vabysmo data among underrepresented DME patients
Study is referred to as the first retinal trial to focus on this patient demographic, finding similar average vision gains to prior research.
Pipeline