DME

The recombinant human VEGFR antibody human complement receptor 1 (CR1) fusion protein will be intravitreally administered in up to 150 patients.

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up to 24 weeks across currently-approved indications.

Topline data from both phase 3 trials are expected in the second quarter of 2026, with NDA submission to follow thereafter.

Rachelle Lin, OD, MS, FAAO, and Quan Đông Nguyễn, MD, MSc, presented available treatment options and what is coming down the pipeline for retinal conditions.

Additionally, the prognosis of macular edema may help clinicians evaluate renal function, investigators reported.

Susvimo 100 mg/mL for intravitreal use via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure, continuously delivering a customized formulation of ranibizumab over time.

The company's lead product candidate Duravyu (vorolanib intravitreal insert), f/k/a EYP-1901, is anticipating topline data from several clinical trials in 2026.

The company will prioritize its cash in funding its ongoing Phase 1/2 PRISM clinical trial and Phase 3 4FRONT program.

Brolucizumab significantly improves anatomic parameters of patients with diabetic macular edema.

The study evaluates Duravyu’s efficacy, durability, and re-dosing every 6 months in both treatment-naïve and previously treated patients.

The OCS-01 eye drops, which utilize an OPTIREACH formulation of high concentration dexamethasone, are intended to be a non-invasive topical treatment.

It’s time to act with a few rational and relatively modest proposals.

The 2-year Phase III data demonstrates Susvimo’s potential as an alternative to eye injections to treat diabetic macular edema and diabetic retinopathy.

The company also submitted a marketing authorization application with the European Medicines Agency.

Amid conflicting findings, factors such as dosage, patient characteristics may affect outcomes.

Conditionally accepted by the FDA as EYO-1901, DURAVYU is a tyrosine kinase inhibitor intended to improve signs and symptoms of non-proliferative diabetic retinopathy in the PAVIA trial.

The company stated that 46.2% of patients demonstrated a 1- or 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks in the Axpaxli arm, compared to 0% in the control arm.

According to Genentech, RVO is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration and diabetic macular edema. The approval is based on two Phase III studies demonstrating early and sustained vision improvements that were non-inferior to aflibercept.

According to Regeneron, the approval was based on data in the PULSAR and PHOTON trials, in which the drug demonstrated clinically equivalent vision gains to aflibercept Injection 2 mg that were maintained with fewer injections.

Oculis Holding AG announced, if approved, OCS-01 has the potential to become a new standard of care as the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.

Over the past decade the progress in retinal disease treatments has exploded with increased numbers of approved pharmaceutical compounds, resulting in more options for treating retinal disease with intravitreal agents and more are in the pipeline.

The trial is evaluating Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for DME patients who respond suboptimally to anti-VEGF therapy.

According to the company, the study has now reached its goal of 300 patients enrolled to evaluate ILUVIEN as a first line, baseline therapy for DME.

Today, Alimera Sciences announced that they have acquired the US commercial rights of Yutiq (fluocinolone acetonide intravitreal insert) 0.18mg for the treatment of chronic non-infectious uveitis. Yutiq now joins Iluvien (fluocinolone acetonide intravitreal insert) 0.19 mg for DME in Alimera’s retina portfolio.

New research identifies potential new TED biomarkers based on the disease activity or inactivity.