- Tags: DME
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
Eclipse Life Sciences launches phase 2 trial on DME steroid implant
Intravitreally-injected implant is being evaluated as a 6-month, extended release therapeutic option.
Research
Vabysmo provides long-term durability in DME extension study
Four-year data finds nearly 80% of patients extended treatment intervals to 3 or 4 months, with 90% reporting absence of DME.
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.
Business
Merck officially enters ophthalmic space with EyeBio acquisition
Pharmaceutical giant now owns Restoret (EYE103), an investigational, tri-specific antibody for DME and wet AMD.
Products
Genentech's Vabysmo PFS earns FDA approval for retinal diseases
Prefilled Syringe version of the bispecific antibody is indicated for treating wet AMD, DME, and RVO.
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.
Research
How prevalent are hyper-reflective foci in DME?
Researchers find potential link between HRF and disease severity among diabetic macular edema patients.
Business