secwatch.observer — SEC 8-K summary
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Issuer:     Opus Genetics, Inc. (IRD)
CIK:        0001228627
Form:       8-K
Filed at:   2026-10-15T21:23:06+00:00
Accession:  0001140361-26-039781
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Opus Genetics: OPGx-BEST1 helps 75% of evaluable patients; OPGx-LCA5 Phase 3 dosing set for Q4 2026
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- OPGx-BEST1 low-dose Cohort 1 (1.5E9 vg/eye): 3 of 4 evaluable patients (75%) improved retinal sensitivity in the treated transitional zone, 3-6 months follow-up.
- High-dose Cohort 2 (4.5E9 vg/eye) fully enrolled with 11 participants; FDA aligned on a >=3 dB gain at >=5 loci in treated transitional zone as endpoint.
- OPGx-LCA5 Phase 1/2 at 1E10 vg/eye: 3 adults sustained visual acuity and light sensitivity gains through 24 months; 3 pediatric patients improved through 6 months.
- OPGx-LCA5 Phase 3 natural-history and treatment cohorts fully enrolled; dosing expected Q4 2026, primary endpoint retinal sensitivity across 16 central test locations.
- OCT EZ-to-RPE thickness rose ~11.1 um in treated eyes vs 1.5 um in untreated fellow eyes by Day 90 in 3 participants; BEST1 US prevalence ~23,600.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1228627/000114036126039781/0001140361-26-039781-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1228627/000114036126039781/ef20083857_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-039781

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