4DMT Announces Positive Interim Data from 4D-150 SPECTRA Clinical Trial in DME and Alignment with FDA on Registrational Path

Core Insights - 4D Molecular Therapeutics announced positive interim data from the SPECTRA clinical trial for 4D-150 in diabetic macular edema (DME) and received FDA alignment on the registrational pathway for the product [1][4][7] Clinical Trial Results - 4D-150 demonstrated strong clinical activity with a sustained gain in best corrected visual acuity (BCVA) of +8.4 letters and a reduction in central subfield thickness (CST) of -194 µm from baseline through Week 32 [4][5] - The 3E10 vg/eye dose level achieved an 86% reduction in injection burden compared to projected on-label aflibercept 2mg Q8W, with a mean of 0.6 supplemental injections per patient through Week 32 [4][5][10] Safety Profile - 4D-150 was well tolerated with no intraocular inflammation observed at any timepoint or dose level, and all patients completed the 16-week corticosteroid taper without complications [4][5][10] Regulatory Update - The FDA has agreed that a single Phase 3 clinical trial will be sufficient for a Biologics License Application (BLA) submission for 4D-150 in DME, based on data from the SPECTRA and PRISM clinical trials [4][6][10] - The planned Phase 3 trial will involve approximately 300-400 patients, focusing on BCVA noninferiority compared to on-label aflibercept 2mg [10] Market Potential - 4D-150 is positioned as a transformative therapy for the approximately one million DME patients in the U.S., potentially reducing the need for frequent injections and improving patient adherence to treatment [2][9][10] - The product aims to provide multi-year sustained delivery of anti-VEGF therapy with a single intravitreal injection, addressing significant unmet medical needs in DME and wet age-related macular degeneration (AMD) [8][9][10]