4D Molecular enrolls first patients in 4SIGHT Phase 3 DME trial; 4D-150 shows +10.8-letter BCVA gain at 2 years

4D Molecular Therapeutics, Inc.

First patients enrolled across multiple sites in 4SIGHT, a global Phase 3 trial of intravitreal 4D-150 in treatment-naive DME (N=514) vs aflibercept 2 mg Q8W.
Primary endpoint: non-inferiority in mean BCVA change from baseline at Week 52; key secondary endpoints are injection burden reduction and >=2-step ETDRS-DRSS improvement.
4D-150 has FDA Regenerative Medicine Advanced Therapy designation; company says FDA and EMA alignment supports BLA/MAA filing on the single 4SIGHT trial plus SPECTRA/PRISM data.
SPECTRA 2-year data (cutoff March 12, 2026): Phase 3 dose (3E10 vg/eye, n=9) gave +10.8 letter mean BCVA gain and -176 um CST reduction; no intraocular inflammation or ocular SAEs (N=22).
61% treatment burden reduction vs on-label aflibercept Q8W (5.2 vs 13.0 projected injections); 75% estimated under 4SIGHT criteria (3.2 injections); 2 of 9 patients injection-free.

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