- Tags: DME
Products
FDA approves Lupin's Lucentis biosimilar injection
Ranluspec (ranibizumab-hkdz) marks the third ranibizumab biosimilar cleared in the U.S. to treat five retinal indications.
Research
4-year data shows Vabymso delivers lasting DME results with fewer injections
Open-label extension study demonstrates long-term safety, efficacy, and tolerability of faricimab in DME patients.
Pipeline
Oculis's phase 3 DME eye drop trial fails primary goals
While OCS-01 was well-tolerated, the DIAMOND program did not meet either outcome measures; company will not seek an FDA NDA filing.
Research
Neuvasq highlights novel antibody approach for restoring blood-retina barrier in wet AMD and DME
Preclinical data of NVQ401 and NVQ501 demonstrate improvements in BRB integrity and function in vascular retinopathy models.
Research
Oculis's global DME consensus study identifies critical gaps in care
Expert panel highlights disease management while emphasizing the importance of early intervention and non-invasive treatment options based on BCVA outcomes.Pipeline
Oculis reports final phase 3 patient visit for DME eye drops
Topline data on OCS-01 from DIAMOND program expected in June 2026 with the goal of supporting an NDA submission in Q4 2026.
Products
FDA approves expanded EYLEA HD dosing intervals
VEGF inhibitor cleared for every 20 weeks among wet AMD and DME patients; clearance based on 96-week data from the PHOTON and PULSAR pivotal trials.
Pipeline
EyePoint begins dosing in phase 3 DME trials for DURAVYU
COMO and CAPRI pivotal studies are evaluating vorolanib insert when intravitreally-injected every 6 months; topline data expected H2 2027.
Pipeline
BioAge Labs expands into DME clinical program for oral inhibitor asset
Preclinical evidence on NLRP3 inhibitor BGE-102 shows potential for therapeutic retinal exposure, with an initial POC trial to kick off later this year.
Research
GLP-1 use may lower long-term DME, DR risk
Study highlights protective effect of GLP-1 RAs against ocular complications of diabetes and disparities for racialized patients
Products
FDA approves Formycon and Bioeq's Lucentis biosimilar
Nufymco (ranibizumab-leyk) marks the companies’ second ranibizumab biosimilar cleared in the U.S. to treat five retinal indications.
Research
Study links DME to systemic microvascular complications in diabetes
Analysis highlights the interconnected relationship between DR, neuropathy, and nephropathy in T2DM.
Pipeline
Coave Therapeutics debuts lead SCS gene therapy for retinal vascular diseases
In-office, suprachoroidal delivery of CoTx-101 offers potential for durable and long-lasting vision gains in treating wet AMD and 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