March 1, 2025 - 00:01
4DMT has reported encouraging interim data from its ongoing clinical trials, showcasing significant advancements in its treatment for wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The results from the PRISM Phase 1/2 trial for 4D-150 indicate robust and durable clinical activity across a diverse patient population, with a favorable tolerability profile observed over a 52-week period and beyond.
In addition to the AMD findings, the company also revealed positive interim results from the SPECTRA clinical trial, specifically from Part 1, which focuses on DME. These 32-week data results are pivotal as they demonstrate the potential effectiveness of 4D-150 in treating this condition.
Moreover, 4DMT has achieved alignment with the FDA regarding its development strategy, indicating that a single Phase 3 trial could be sufficient for a Biologics License Application (BLA) submission for 4D-150 in DME, especially when combined with data from the 4FRONT study. This strategic direction marks a significant milestone for the company as it seeks to advance its therapeutic offerings in the ophthalmology space.
