---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-23-051009"
form_type: "8-K"
ticker: "IRD"
cik: "0001228627"
company_name: "Opus Genetics, Inc."
filed_at: "2023-11-02T23:59:59+00:00"
generated_at: "2026-06-08T23:28:07.459430+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Ocuphire successful End-of-Phase 2 meeting with FDA for oral APX3330 in diabetic retinopathy

## Summary
- FDA agreed on Phase 3 primary endpoint: ≥3-step worsening on binocular DRSS; SPA to be submitted.
- APX3330 could be first oral option for ~8M US NPDR patients; Phase 2 ZETA-1 showed slowing of DR progression.
- Company plans Special Protocol Assessment to finalize trial design and timing with FDA.
- Phase 2 ZETA-1 met primary endpoint: lower % of APX3330-treated patients had ≥3-step worsening vs placebo at 24 weeks.
- APX3330 demonstrated favorable safety/tolerability; CEO calls it 'most advanced oral therapy in development for DR'.

## SEC filing metadata
- accession: 0001140361-23-051009
- form_type: 8-K
- ticker: IRD
- cik: 0001228627
- company_name: Opus Genetics, Inc.
- filed_at: 2023-11-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1228627/000114036123051009/0001140361-23-051009-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1228627/000114036123051009/ef20013910_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-23-051009
- JSON: https://secwatch.observer/filing/0001140361-23-051009.json
- Plain text: https://secwatch.observer/filing/0001140361-23-051009.txt

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