DME

The company announced 27 abstracts at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting from May 4 to 8 in Salt Lake City, Utah.

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.

The annual ARVO meeting will be held in Salt Lake City, Utah and feature presentation on clinical trials from around the globe.

The research team noted that racial subgroups are underrepresented in clinical trials, a factor that should be addressed in future clinical trials.

This agreement allows a launch in the US in the second half of 2026 or earlier in certain circumstances.

VX01-DR-201, is a phase 2, multicenter, double-masked, randomized, placebo-controlled study in patients with moderate to severe NPDR without center-involved diabetic macular edema (CI-DME).

The investigators conducted a prospective interventional study to determine the therapeutic anatomic and functional effects of one intravitreal dexamethasone implant in eyes with refractory diabetic macular edema.

UBX1325 is a novel BCL-xL inhibitor designed to eliminate senescent cells in diabetic retinal blood vessels, while leaving healthy ones intact.

After review by the Data and Safety Monitoring Board, the dosing of OCU200 in patients with diabetic macular edema (DME) will continue.

This treatment is already approved for both diabetic macular edema (DME) and NIU-PS outside the US, including in 17 European countries.

24-week topline data from the phase 2b ASPIRE study in diabetic macular edema (DME) are expected to be released in Q1 of 2025.

Visual acuity with both approaches was comparable and the device was efficacious and safe.

At the Envision Summit 2025 in San Juan, Puerto Rico, Sherrol Reynolds, OD, FAAO, participated in a discussion on patient-centered care and the newest treatment strategies in neovascular AMD and DME.

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 treatment showed stability or improvement in the Diabetic Retinopathy Severity Scale (DRSS) and generally the drug was well tolerated.

ARCATUS or ARVN001, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries is formally known as XIPERE in the United States and was developed by Clearside Biomedical.

The phase 1 clinical trial is a multicenter, open-label, dose-escalation study to assess drug safety via intravitreal injection in 3 cohorts.

The new funding will allow the company to complete its ongoing Phase 2 trial of proprietary nanomedicine, migaldendranib, in patients with wet AMD and DME

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

Oxular began a phase 2 trial for its therapeutic candidate OXU-001, for the treatment of diabetic macular edema in October 2024.

Investigators conducted a meta-analysis of randomized controlled trials to assess the efficacy and safety of brolucizumab compared with aflibercept in patients with DME.

Enhancing durability and reducing treatment burden.

Researchers conducted a retrospective study to assess serum inflammatory biomarkers in patients with different subtypes of diabetic macular edema (DME).

Early results suggest participant diversity and novel measures will enable new, artificial intelligence-driven insights. As the study evolves, it could lead to significant advancements in understanding how environmental exposures contribute not only to diabetes but also to its complications, including those affecting eye health, such as diabetic retinopathy.