---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-403424"
form_type: "8-K"
ticker: "FDMT"
cik: "0001650648"
company_name: "4D Molecular Therapeutics, Inc."
filed_at: "2026-09-28T12:05:05+00:00"
generated_at: "2026-10-12T13:31:00.298562+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-403424
- form_type: 8-K
- ticker: FDMT
- cik: 0001650648
- company_name: 4D Molecular Therapeutics, Inc.
- filed_at: 2026-09-28T12:05:05+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1650648/000119312526403424/0001193125-26-403424-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1650648/000119312526403424/d147828d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-403424
- JSON: https://secwatch.observer/filing/0001193125-26-403424.json
- Plain text: https://secwatch.observer/filing/0001193125-26-403424.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.