COMPANY
Opus Genetics Inc
Funding and NIH signals
- NIH award NIH awarded $1M (SBIR Phase II 1R44EY038152-01A1, new, notice Sep 19, 2026); 2 NIH awards totaling $2.02M in the last 12 months. NIH RePORTER 1R44EY038152-01A1 (Sep 19, 2026)
Evidence (2 events)
- Sep 19, 2026 · NIH RePORTER 1R44EY038152-01A1
Organization: OPUS GENETICS INC.; City/State: RALEIGH, NC; Project number: 1R44EY038152-01A1; Activity code: R44; Fiscal year: 2026; Award notice date: 2026-09-19; FY total cost (award amount): 1004925; Administering IC: National Eye Institute; Project title: Development of OPGx-RDH12 as a gene therapy for RDH12 deficiency associated Leber congenital amaurosis (LCA); Organization type: Domestic For-Profits - Sep 17, 2026 · NIH RePORTER 1R44EY038149-01A1
Organization: OPUS GENETICS INC.; City/State: RALEIGH, NC; Project number: 1R44EY038149-01A1; Activity code: R44; Fiscal year: 2026; Award notice date: 2026-09-17; FY total cost (award amount): 1012469; Administering IC: National Eye Institute; Project title: Development of OPGx-NMNAT1 as a gene therapy for NMNAT1 associated LCA.; Organization type: Domestic For-Profits
- Sep 19, 2026 · NIH RePORTER 1R44EY038152-01A1
Timeline
- Trial start Phase 1/Phase 2: Safety and Tolerability of Subretinal OPGx-RDH12-1001 for LCA-Associated Inherited Retinal Degeneration (LCA-IRD) source ↗
- Raise Private placement: $25M (total, as published), announced Feb 13, 2026. Source: company release on GlobeNewswire. source ↗
- Raise Follow-on offering — Registered direct: $23M (total, as published), announced Nov 6, 2025. Source: SEC filing. source ↗
- Trial start Phase 1/Phase 2: Safety and Tolerability of Subretinally Injected OPGx-BEST1 in Patients With Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB) source ↗
- Trial start Phase 3: OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity source ↗
- Raise Follow-on offering: $20M (total, as published), announced Mar 21, 2025. Source: company release on GlobeNewswire. source ↗
- Trial start Phase 3: Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia source ↗
- Trial start Phase 3: Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances source ↗
- Trial start Phase 1/Phase 2: Safety and Tolerability Subretinal OPGx-001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD) and Non-interventional Arm With Untreated Patients source ↗
- Trial start Phase 3: Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia source ↗
- Trial start Phase 3: Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects source ↗
- Trial start Phase 3: Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3) source ↗
- Trial start Phase 2: Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy source ↗
- Trial start Phase 2: Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia source ↗
- Trial start Phase 3: Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances source ↗
- Trial start Phase 3: Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis source ↗
- Trial start Phase 2: Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis source ↗
- Trial start Phase 2: Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma source ↗
- Trial start Phase 2: The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances source ↗
- Trial start Phase 2: Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances source ↗
Upcoming milestones
- 2027-08 (ESTIMATED) · Phase 3 · OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity · NCT07140783
- Jun 15, 2028 (ESTIMATED) · Phase 1/Phase 2 · Safety and Tolerability Subretinal OPGx-001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD) and Non-interventional Arm With Untreated Patients · NCT05616793
- 2030-08 (ESTIMATED) · Phase 1/Phase 2 · Safety and Tolerability of Subretinally Injected OPGx-BEST1 in Patients With Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB) · NCT07185256
- 2032-12 (ESTIMATED) · Phase 1/Phase 2 · Safety and Tolerability of Subretinal OPGx-RDH12-1001 for LCA-Associated Inherited Retinal Degeneration (LCA-IRD) · NCT07681778
Funding
- Private placement: $25M (total, as published), announced Feb 13, 2026. Source: company release on GlobeNewswire. source ↗
- Follow-on offering — Registered direct: $23M (total, as published), announced Nov 6, 2025. Source: SEC filing. source ↗
- Follow-on offering: $20M (total, as published), announced Mar 21, 2025. Source: company release on GlobeNewswire. source ↗
Clinical trials (lead sponsor) 17
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT01703559 | The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances | Phase 2 | Completed | Sep 9, 2011 | Apr 16, 2012 (actual) |
| NCT07185256 | Safety and Tolerability of Subretinally Injected OPGx-BEST1 in Patients With Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB) | Phase 1/Phase 2 | Recruiting | Sep 25, 2025 | 2030-08 (estimated) |
| NCT07140783 | OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity | Phase 3 | Recruiting | Sep 2, 2025 | 2027-08 (estimated) |
| NCT06349759 | Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances | Phase 3 | Completed | Apr 1, 2024 | Apr 17, 2025 (actual) |
| NCT06542497 | Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia | Phase 3 | Completed | Aug 15, 2024 | Apr 3, 2025 (actual) |
| NCT07681778 | Safety and Tolerability of Subretinal OPGx-RDH12-1001 for LCA-Associated Inherited Retinal Degeneration (LCA-IRD) | Phase 1/Phase 2 | Not yet recruiting | Sep 1, 2026 | 2032-12 (estimated) |
| NCT05646719 | Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia | Phase 3 | Completed | Dec 22, 2022 | Oct 11, 2023 (actual) |
| NCT04692688 | Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy | Phase 2 | Completed | Apr 8, 2021 | Jan 25, 2023 (actual) |
| NCT05616793 | Safety and Tolerability Subretinal OPGx-001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD) and Non-interventional Arm With Untreated Patients | Phase 1/Phase 2 | Recruiting | Jun 15, 2023 | Jun 15, 2028 (estimated) |
| NCT04638660 | Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances | Phase 3 | Completed | Dec 30, 2020 | May 19, 2022 (actual) |
| NCT04675151 | Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia | Phase 2 | Completed | Feb 15, 2021 | May 17, 2021 (actual) |
| NCT04004507 | Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances | Phase 2 | Completed | 2007-08 | 2007-10 (actual) |
| NCT03960866 | Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma | Phase 2 | Completed | May 28, 2019 | Sep 11, 2019 (actual) |
| NCT04620213 | Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis | Phase 3 | Completed | Nov 18, 2020 | Dec 23, 2020 (actual) |
| NCT05223478 | Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects | Phase 3 | Completed | Dec 17, 2021 | Apr 18, 2022 (actual) |
| NCT05134974 | Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3) | Phase 3 | Completed | Nov 18, 2021 | Mar 18, 2022 (actual) |
| NCT04024891 | Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis | Phase 2 | Completed | Aug 13, 2019 | Sep 17, 2019 (actual) |
Raises and investors new
- Raise Private raise (SEC Form D): $25.8M sold; issuer “Opus Genetics, Inc.”. Verified from the SEC filing. SEC filing ↗