Opus Genetics, Inc. IRD
Opus Genetics, Inc. (Nasdaq: IRD) is an ophthalmology drug developer. Its lead program, Phentolamine Ophthalmic Solution 0.75% (PS) - presbyopia sNDA and LYNX-3 (mesopic vision); OPGx-LCA5 is co-lead registrational gene therapy, is in Phase 3 for Presbyopia (sNDA under FDA review, PDUFA 2026-10-17); decreased mesopic vision after keratorefractive surgery (LYNX-3 Phase 3). Its next catalyst on record is OPGx-BEST1: Present data at EURETINA Congress (October 2026).
Upcoming catalysts
- October 2026OPGx-BEST1 — Present data at EURETINA Congress
In addition, we plan to present the data at the annual EURETINA Congress taking place in Vienna, Austria in October 2026.
Next further out: OPGx-RDH12 — Enter the clinic (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| PS (phentolamine ophthalmic solution 0.75%) - presbyopia | Presbyopia (two Phase 3 trials positive; Viatris sNDA accepted, PDUFA Oct 17, 2026) | small molecule | Phase 3 |
| PS - LYNX-3 | Night driving impairment / reduced mesopic vision after keratorefractive surgery (SPA, Fast Track) | small molecule | Phase 3 |
| OPGx-LCA5 | LCA5-related Leber congenital amaurosis (registrational Phase 3 in 8 participants; enrollment complete Aug 2026) | gene therapy | Phase 3 |
| OPGx-BEST1 | BEST1-related retinal degeneration (BVMD, ARB); BIRD-1 Phase 1/2 | gene therapy | Phase 2 |
| OPGx-RDH12 | RDH12 retinal dystrophy | gene therapy | Pre-clinical |
| OPGx-MERTK | MERTK retinal degeneration | gene therapy | Pre-clinical |
| OPGx-RHO | Autosomal dominant retinitis pigmentosa (RHO) | gene therapy | Pre-clinical |
| OPGx-CNGB1 / OPGx-NMNAT1 and other undisclosed | Inherited retinal diseases | gene therapy | Pre-clinical |
Recent results and decisions
- Aug 6, 2026completed enrollment Enrollment completed in the 8-participant registrational Phase 3 trial of OPGx-LCA5 (FDA alignment on design with 6-month run-in); dosing to begin Q4 2026.
Enrollment in the trial was completed, with dosing of OPGx-LCA5 expected to begin in the fourth quarter of 2026 using clinical drug supply manufactured with the intended commercial processes.
Filing - May 12, 2026positive Six-month pediatric cohort data presented at ARVO 2026: average ~1.5 log unit gain in cone sensitivity reaching normal ranges after a single dose, with improved visual acuity and functional vision; well tolerated.
Positive six-month pediatric cohort data was presented at ARVO 2026; robust and consistent improvements were observed in cone-mediated function with average gains of approximately 1.5 log unit in cone sensitivity, reaching normal ranges after a single dose.
Filing - Mar 10, 2026accepted FDA accepted the sNDA for Phentolamine Ophthalmic Solution 0.75% in presbyopia with a PDUFA action date of October 17, 2026.
The FDA accepted the Company's supplemental New Drug Application (sNDA) for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia and set a PDUFA action date of October 17, 2026.
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 ophthalmology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.