4DMT Launches Phase 3 4SIGHT Trial for DME, Reports Strong 2-Year SPECTRA Data
FDMT has more than doubled off its 52-week low of $6.96.
Summary
4DMT has enrolled the first patients in its 4SIGHT Phase 3 trial of 4D-150 for diabetic macular edema (DME), marking the second Phase 3 program for the gene therapy. The global trial (N=514) has a primary endpoint of non-inferiority in BCVA change at Week 52, with key secondary endpoints including treatment burden reduction and ≥2-step ETDRS-DRSS improvement. The company also released 2-year SPECTRA data showing a +10.8 letter BCVA gain, -176 µm CST reduction, and 61% treatment burden reduction with the Phase 3 dose, with no intraocular inflammation, no ocular SAEs, and 22% injection-free. FDA and EMA alignment on potential BLA/MAA filings with a single 4SIGHT trial significantly de-risks the regulatory path. This follows the July 2026 positive two-year PRISM data in wet AMD and the completion of enrollment in the 4FRONT Phase 3 trials. The DME market is large (~1 million U.S. patients), and 4D-150's potential to reduce injection burden addresses a major unmet need. Watch for 4SIGHT enrollment completion and interim data, though no specific timeline was provided.
Updated with an SEC 8-K filing · What changed
Updates
· SEC 8-K — 4SIGHT is a global Phase 3 trial (N=514) with primary endpoint non-inferiority in BCVA change at Week 52; key secondary endpoints include treatment burden reduction and ≥2-step ETDRS-DRSS improvement. SPECTRA 2-year data: no intraocular inflammation, no ocular SAEs, 22% injection-free.
At the time of this announcement, FDMT was trading at $14.30 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $799.4M. The 52-week trading range was $6.96 to $16.93. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.