---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-036637"
form_type: "8-K"
ticker: "IRD"
cik: "0001228627"
company_name: "Opus Genetics, Inc."
filed_at: "2025-09-30T23:59:59+00:00"
generated_at: "2026-05-17T05:13:36.220609+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Opus Genetics LCA5 gene therapy shows 0.3 logMAR improvement in pediatric cohort; durable 18-month adult data

## Summary
- Three pediatric participants (ages 16-17) showed group avg 0.3 logMAR visual acuity improvement and >1 log unit cone sensitivity improvement on FST.
- All three pediatric participants improved on mobility test; microperimetry showed improved fixation in one evaluable participant.
- Adult data (3 participants) show visual acuity improvements sustained through 18 months; therapy well-tolerated with no ocular SAEs.
- Company expects to meet with FDA in Q4 2025 to discuss results and next steps for OPGx-LCA5 program.
- No ocular serious adverse events or dose-limiting toxicities; all ocular AEs mild, anticipated, not related to study drug.

## SEC filing metadata
- accession: 0001140361-25-036637
- form_type: 8-K
- ticker: IRD
- cik: 0001228627
- company_name: Opus Genetics, Inc.
- filed_at: 2025-09-30T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1228627/000114036125036637/0001140361-25-036637-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1228627/000114036125036637/ef20056246_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-036637
- JSON: https://secwatch.observer/filing/0001140361-25-036637.json
- Plain text: https://secwatch.observer/filing/0001140361-25-036637.txt

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