---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-046187"
form_type: "8-K"
ticker: "IRD"
cik: "0001228627"
company_name: "Opus Genetics, Inc."
filed_at: "2025-12-19T23:59:59+00:00"
generated_at: "2026-05-16T12:31:45.843861+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Opus Genetics partner Viatris files sNDA with FDA for presbyopia treatment

## Summary
- Viatris filed sNDA for Phentolamine Ophthalmic Solution 0.75% to treat presbyopia.
- sNDA supported by positive VEGA-3 Phase 3 results confirming efficacy, safety, durability.
- No assurance FDA will accept sNDA or complete review on anticipated timeline.

## SEC filing metadata
- accession: 0001140361-25-046187
- form_type: 8-K
- ticker: IRD
- cik: 0001228627
- company_name: Opus Genetics, Inc.
- filed_at: 2025-12-19T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1228627/000114036125046187/0001140361-25-046187-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1228627/000114036125046187/ef20061683_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-046187
- JSON: https://secwatch.observer/filing/0001140361-25-046187.json
- Plain text: https://secwatch.observer/filing/0001140361-25-046187.txt

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