---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-000615"
form_type: "8-K"
ticker: "IRD"
cik: "0001228627"
company_name: "Opus Genetics, Inc."
filed_at: "2026-01-08T23:59:59+00:00"
generated_at: "2026-05-16T11:10:31.625548+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Opus Genetics details 2025 progress and 2026 catalysts; cash >$50M, sNDA for presbyopia submitted

## Summary
- sNDA submitted for phentolamine 0.75% (presbyopia); FDA decision expected by end of 2026.
- BEST1 Phase 1/2 initial data this quarter at Macula Society; Cohort 1 3-month results mid-2026.
- LCA5 Phase 3 pivotal trial dosing expected in H2 2026 after run-in enrollment.
- Cash and equivalents >$50M following $23M equity raise; runway into H2 2027.
- One to two preclinical IRD programs (RHO, CNGB1, MERTK, RDH12-LCA, NMNAT1) targeting clinical entry in 2026.

## SEC filing metadata
- accession: 0001140361-26-000615
- form_type: 8-K
- ticker: IRD
- cik: 0001228627
- company_name: Opus Genetics, Inc.
- filed_at: 2026-01-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1228627/000114036126000615/0001140361-26-000615-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1228627/000114036126000615/ef20062523_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-000615
- JSON: https://secwatch.observer/filing/0001140361-26-000615.json
- Plain text: https://secwatch.observer/filing/0001140361-26-000615.txt

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