secwatch.observer — SEC 8-K summary
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Issuer:     4D Molecular Therapeutics, Inc. (FDMT)
CIK:        0001650648
Form:       8-K
Filed at:   2026-09-28T12:05:05+00:00
Accession:  0001193125-26-403424
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1650648/000119312526403424/0001193125-26-403424-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1650648/000119312526403424/d147828d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-403424

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer