AMD

Examining the performance of AI algorithms versus human graders in neovascular age-related macular degeneration

At the Envision Summit 2025 in San Juan, Puerto Rico, Deepak Sambhara, MD, gave insight into the 96-week post hoc fluid outcomes analysis of patients who participated in the phase 3 clinical trial PULSAR.

The 36-week trial was a randomized, double-masked, parallel-group, active-controlled, multicenter evaluating CLS-AX (axitinib injectable suspension) in participants with neovascular age-related macular degeneration.

Results were published from the phase 3 QUASAR trial and the extension study of the phase 3 PULSAR trial.

PRISM evaluates 4D-150, a potential backbone therapy designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection.

Patients commonly reported unexplained blurred or hazy vision postoperatively that requires further investigation

This research team evaluated the effectiveness of switching patients to faricimab treatment by assessing their outcomes after 6 months of treatment in a retrospective chart review that included 102 patients with nAMD who had had suboptimal responses to other anti-VEGF therapies.

The company offers year-round educational services on the conditions, using this month, in particular, to guide patients to needed resources.

The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated for treatment of AMD.

Results from the study assisted Notal Vision in receiving De Novo authorization from the US FDA for the SCANLY Home OCT in 2024.

The trial evaluated ONS-5010 in wet age-related macular degeneration patients, and the company plans to resubmit a Biologics License Application in the first quarter of 2025.

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.

In this study, researchers examine immune mechanisms in ocular diseases like uveitis, AMD, DR, and GO, highlighting microglial roles, targeted therapies, and promising advances in immunotherapy.

A look at the biggest news and advancements in ophthalmology in 2024.

The report details the results of preclinical discovery, engineering and characterization studies evaluating the safety, retinal cell transduction, transgene expression and clinical activity of proprietary evolved intravitreal vector R100 and 4D-150.

The EMA issued a positive opinion and recommendation for marketing authorization for Eydenzelt (biosimilar aflibercept).

Researchers at the USC Ginsburg Institute for Biomedical Therapeutics and the USC Roski Eye Institute are advancing a new treatment for dry age-related macular degeneration, a leading cause of blindness in older adults.

The joint project AMD-HALT, pairs Amarna’s SV40-derived gene delivery vector platform with Phenocell’s in vitro AMD disease model, which accurately mimics cellular interactions and microenvironment of the retina

EXG102 and EXG202 are investigational gene therapy candidates for wet age-related macular degeneration that are in development.

The company begins phase 1 trials of oral GAL-101, targeting amyloid beta aggregation. Promising safety and efficacy in ophthalmic models suggest potential for treating dry AMD, glaucoma, and neurodegenerative eye diseases.

SOL-1 is a superiority study being conducted under a Special Protocol Agreement (SPA) with the US Food and Drug Administration (FDA).