4D Molecular enrolls first patients in 4SIGHT Phase 3 DME trial, reports 2-year SPECTRA data
4D Molecular Therapeutics said first patients have been enrolled across multiple sites in the 4SIGHT Phase 3 trial of 4D-150 for diabetic macular edema, and reported 2-year data from the SPECTRA trial. The SPECTRA results cover a small group of 9 patients at the Phase 3 dose, and the company describes the 75% treatment burden reduction as a retrospective estimate.
Key points
- 4SIGHT is a global Phase 3 trial with 514 treatment-naive DME patients, comparing 4D-150 against aflibercept 2 mg Q8W.
- SPECTRA 2-year safety (N=22): no intraocular inflammation and no ocular serious adverse events reported.
- At the Phase 3 dose (n=9), mean BCVA gain was +10.8 letters and mean CST reduction was -176 µm.
- Reported supplemental injections were 61% lower than the 13.0 projected with on-label aflibercept; 2 of 9 (22%) patients remained injection-free.
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 28, 2026.
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