secwatch.observer — SEC 8-K summary
======================================

Issuer:     4D Molecular Therapeutics, Inc. (FDMT)
CIK:        0001650648
Form:       8-K
Filed at:   2024-07-17T23:59:59+00:00
Accession:  0001193125-24-179950
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

4D-150 Phase 2 interim data shows 89% injection rate reduction, 77% injection-free at 24 weeks in wet AMD
--------------------------------------------------------------------------------

- Planned Phase 3 dose (3E10 vg/eye): 89% reduction in mean annualized injection rate; 77% injection-free at 24 weeks.
- No 4D-150-related SAEs, no hypotony, retinal vasculitis, or choroidal effusions observed in any patient across trials (n=139).
- BCVA improved by +4.2 letters from baseline at 3E10 dose; injection-free patients saw +4.7 letters; dose response favored higher dose.
- Phase 1 patients (n=3) treated at 3E10 remained injection-free through ~2-2.5 years; BCVA and CST stable.
- Expects to announce Phase 3 trial design in Sep 2024, initiate in Q1 2025; 52-week data and DME data due in H2 2024/early 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1650648/000119312524179950/0001193125-24-179950-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1650648/000119312524179950/d873208d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-179950

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