---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-035979"
form_type: "8-K"
ticker: "IRD"
cik: "0001228627"
company_name: "Opus Genetics, Inc."
filed_at: "2026-09-09T11:30:47+00:00"
generated_at: "2026-09-09T11:35:17.154951+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Opus Genetics reports positive Cohort 1 data for OPGx-BEST1; FDA aligns on pivotal endpoint

## Summary
- All 5 Cohort 1 participants showed clinically meaningful visual function improvement; BCVA improved in 3/5, microperimetry in 3/4 evaluable.
- No serious adverse events or dose-limiting toxicities; structural improvements in 4/5, including vitelliform reduction in 2/3 BVMD.
- FDA aligned on ≥3 dB microperimetry improvement in ≥5 loci with patient-reported outcome as potential pivotal endpoint.
- Cohort 2 over-enrolled to 8 participants; dosing complete Q4 2026, topline data Q2 2027; cash runway into 2029.
- New epidemiology estimates ~23,600 symptomatic BEST1 patients in US and ~45,400 globally.

## SEC filing metadata
- accession: 0001140361-26-035979
- form_type: 8-K
- ticker: IRD
- cik: 0001228627
- company_name: Opus Genetics, Inc.
- filed_at: 2026-09-09T11:30:47+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1228627/000114036126035979/0001140361-26-035979-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1228627/000114036126035979/ef20081753_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-035979
- JSON: https://secwatch.observer/filing/0001140361-26-035979.json
- Plain text: https://secwatch.observer/filing/0001140361-26-035979.txt

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