On July 31, 2025, 4D Molecular Therapeutics announced positive 60-week results from its SPECTRA clinical trial evaluating 4D-150 in patients with diabetic macular edema (DME). The data, which included both 52-week primary endpoint and 60-week analyses, were presented at the 43rd Annual American Society of Retina Specialists (ASRS) Scientific Meeting.
The results demonstrated the tolerability and consistent, durable clinical activity of 4D-150 in DME. This highlights the product candidate's potential to significantly reduce treatment burden compared to the labeled regimen of standard-of-care aflibercept 2mg administered every eight weeks, offering meaningful and lasting vision improvement.
In a significant regulatory update, 4DMT also announced alignment with the European Medicines Agency (EMA) on a registrational pathway for 4D-150 in DME. This means that a single successful Phase 3 study could support approval in both the U.S. and Europe, complementing the ongoing 4FRONT wet AMD program and providing a clear, streamlined path to bring 4D-150 to patients.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.