4DMT Reports Positive 2-Year Results from PRISM Phase 2b Trial
The firm shares promising data on its gene therapy for wet AMD.
4D Molecular Therapeutics announced positive two-year outcomes from its PRISM Phase 2b clinical trial of the investigational gene therapy 4D-150 for wet age-related macular degeneration (AMD). The trial demonstrated sustained visual acuity and a significant reduction in treatment burden among participants.
The Phase 2b trial involved 45 patients who received a single intravitreal dose of 4D-150, with 30 patients receiving the higher dose of 3E10 vg/eye. Results indicated that 78% of patients experienced an overall reduction in treatment burden, with an average of 2.7 supplemental injections required compared to a projected 12 injections with standard therapies.
In a subgroup of recently diagnosed patients, the treatment burden reduction reached 87%, with only 1.6 supplemental injections needed. These findings suggest that 4D-150 could significantly alter the treatment landscape for wet AMD, which currently requires frequent injections to maintain vision.
The safety profile of 4D-150 remained favorable, with only a 2.8% incidence of mild intraocular inflammation noted within the first six months of treatment. No new safety concerns were identified in the two years following treatment, indicating that the therapy is well-tolerated.
Dr. Carl Awh presented the data at the 44th Annual Scientific Meeting of the American Society of Retina Specialists, emphasizing the potential of 4D-150 to reduce the treatment burden for patients. “The two-year PRISM results demonstrate the potential of a single intravitreal administration of 4D-150 to provide long-term anti-VEGF and sustained disease control,” he stated.
4D-150 is designed to deliver sustained anti-VEGF biologics within the retina, potentially offering a long-term solution for patients suffering from wet AMD and diabetic macular edema. The ongoing development of this therapy could free patients from the burdensome injection schedules currently required to manage their conditions.
The findings from the PRISM trial are expected to inform subsequent Phase 3 clinical trials, which will further assess the efficacy and safety of 4D-150 in a broader patient population. The announcement was distributed via GlobeNewswire.
This is an independent summary of a press release originally distributed via GlobeNewswire. GAX Online was not paid for this coverage.
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