4D Molecular Therapeutics will present 52-week interim data from the Phase 2b portion of its PRISM clinical trial evaluating 4D-150 for wet age-related macular degeneration (wet AMD). Dr. Dante Pieramici, a principal investigator in the trial, will present the findings at the Angiogenesis, Exudation, and Degeneration 2025 conference on February 8, 2025. A follow-up webcast on February 10, 2025, will feature additional analyses of 4D-150 in wet AMD and diabetic macular edema (DME), including data from a subgroup resembling the Phase 3 trial population.
This data release is important because it offers a more comprehensive look at the potential long-term efficacy and safety of 4D-150, a gene therapy designed for sustained delivery of anti-VEGF treatment. The inclusion of 52-week data is a significant step towards demonstrating the durability of the treatment, a critical factor in reducing the frequency of injections for patients with wet AMD. The focus on a subgroup closely matching the Phase 3 trial population strengthens the relevance of these interim findings for predicting the potential success of the larger, pivotal studies. Furthermore, the inclusion of data on DME broadens the potential therapeutic applications of 4D-150, highlighting its possible impact across multiple retinal diseases.
The February 8th presentation will cover 52-week results from the Phase 2b Population Extension cohort of the PRISM trial evaluating 4D-150 in a broad wet AMD patient population. The February 10th webcast will delve into the 52-week landmark interim efficacy data for the 3E10 vg/eye dose (N=30), with a specific focus on the recently diagnosed subgroup (N=15). It will also feature the latest long-term interim safety data for this dose (N=71 across all PRISM Phase 1/2 patients), the longest available data on aqueous humor aflibercept protein levels, and further details on the previously released 32-week interim data from the SPECTRA Part 1 DME trial.
These interim results represent a crucial milestone for 4DMT and the development of 4D-150. Positive data could significantly bolster confidence in the therapy’s potential to provide long-lasting patient benefits, reducing the burden of frequent injections and potentially improving visual outcomes. Investors and the ophthalmology community will closely watch the upcoming data presentations and subsequent analyses, as they will play a significant role in shaping expectations for the ongoing Phase 3 trials. The data will also provide valuable insight into the broader potential of sustained-release gene therapies for treating chronic retinal diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
