secwatch.observer — SEC 8-K summary
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Issuer:     Opus Genetics, Inc. (IRD)
CIK:        0001228627
Form:       8-K
Filed at:   2026-01-08T23:59:59+00:00
Accession:  0001140361-26-000615
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1228627/000114036126000615/0001140361-26-000615-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1228627/000114036126000615/ef20062523_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-000615

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer