Opus Genetics, Inc. 8K

The 8‑K reports positive early Phase 1/2 OPGx‑BEST1 gene therapy results and FDA endpoint alignment, supporting advancement toward a pivotal trial starting in 2027.

Opus Genetics (Nasdaq: IRD) furnished a corporate presentation as Exhibit 99.1 to a Form 8-K describing encouraging three‑month Phase 1/2 low‑dose Cohort 1 data for its OPGx‑BEST1 gene therapy in BEST1‑related retinal disease, highlighting that the subretinal treatment was well tolerated with no serious adverse events or dose‑limiting toxicities, showed structural and functional vision improvements in most participants, achieved FDA alignment at an August 2026 Type C meeting on a potential pivotal microperimetry‑based endpoint, and remains on track for over‑enrolled high‑dose Cohort 2 completion in Q4 2026, a pivotal trial start and additional data readouts in 2027, supported by a cash runway extending into 2029.

Filing Facts

CIK

1228627

Ticker

-

Form

8K

Source Type

sec

Accession

0001140361-26-036277

Alert Tier

6