---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-039781"
form_type: "8-K"
ticker: "IRD"
cik: "0001228627"
company_name: "Opus Genetics, Inc."
filed_at: "2026-10-15T21:23:06+00:00"
generated_at: "2026-10-15T21:24:05.369335+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Opus Genetics: OPGx-BEST1 helps 75% of evaluable patients; OPGx-LCA5 Phase 3 dosing set for Q4 2026

## Summary
- OPGx-BEST1 low-dose Cohort 1 (1.5E9 vg/eye): 3 of 4 evaluable patients (75%) improved retinal sensitivity in the treated transitional zone, 3-6 months follow-up.
- High-dose Cohort 2 (4.5E9 vg/eye) fully enrolled with 11 participants; FDA aligned on a >=3 dB gain at >=5 loci in treated transitional zone as endpoint.
- OPGx-LCA5 Phase 1/2 at 1E10 vg/eye: 3 adults sustained visual acuity and light sensitivity gains through 24 months; 3 pediatric patients improved through 6 months.
- OPGx-LCA5 Phase 3 natural-history and treatment cohorts fully enrolled; dosing expected Q4 2026, primary endpoint retinal sensitivity across 16 central test locations.
- OCT EZ-to-RPE thickness rose ~11.1 um in treated eyes vs 1.5 um in untreated fellow eyes by Day 90 in 3 participants; BEST1 US prevalence ~23,600.

## SEC filing metadata
- accession: 0001140361-26-039781
- form_type: 8-K
- ticker: IRD
- cik: 0001228627
- company_name: Opus Genetics, Inc.
- filed_at: 2026-10-15T21:23:06+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1228627/000114036126039781/0001140361-26-039781-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1228627/000114036126039781/ef20083857_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-039781
- JSON: https://secwatch.observer/filing/0001140361-26-039781.json
- Plain text: https://secwatch.observer/filing/0001140361-26-039781.txt

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