Drugs / FT-003
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05916391 | May 2023 → May 2025 overdue | diabetic macular edema | Frontera Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT05611424 | May 2023 → Nov 2024 overdue | wet macular degeneration | Frontera Therapeutics | Not yet recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06492876 | Nov 2023 → Nov 2024 overdue | diabetic macular edema | Frontera Therapeutics | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06492863 | Aug 2023 → Oct 2024 overdue | wet macular degeneration | Frontera Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | Frontera Therapeutics | Regulatory Frontera Therapeutics’ FT-003 Achieves Regenerative Medicine Advanced Therapy Designation from the U.S. FDA for Neovascular Age-Related Macular Degeneration fronteratherapeutics.com ↗
Frontera Therapeutics, a clinical-stage biotechnology company focused on innovative AAV gene therapies, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its core product FT-003 for the treatment of neovascular age-related macular degeneration (nAMD). |
| 2026-05-11 | Frontera Therapeutics | Results Frontera Therapeutics Presents Positive Top-Line Phase II Data for FT-002 and FT-003 at ARVO 2026 fronteratherapeutics.com ↗
May 7, 2026 Frontera Therapeutics Presents Positive Top-Line Phase II Data for FT-002 and FT-003 at ARVO 2026 |
| 2025-03-13 | Frontera Therapeutics | Regulatory Frontera Therapeutics Announces IND Clearance for FT-003 in Diabetic Retinopathy fronteratherapeutics.com ↗
March 13, 2025 – Frontera Therapeutics announced today that its proprietary recombinant adeno-associated virus (rAAV) gene therapy, FT-003 Injection, has received Investigational New Drug (IND) clearance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Diabetic Retinopathy (DR). |
| 2024-12-30 | Frontera Therapeutics | Regulatory Frontera Therapeutics Receives FDA Clearance for Phase 2 Clinical Trial of FT-003 for Diabetic Macular Edema (DME) fronteratherapeutics.com ↗
Frontera Therapeutics is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared its AAV gene therapy product, FT-003 Injection, for a Phase 2 clinical trial targeting Diabetic Macular Edema (DME). |
| 2024-11-12 | Frontera Therapeutics | Regulatory FDA Frontera Receives FDA clearance for FT-003 Phase 2 IND in Neovascular Age-Related Macular Degeneration fronteratherapeutics.com ↗
Frontera is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared its Phase 2 Investigational New Drug (IND) application for FT-003 Injection, an innovative recombinant adeno-associated virus (rAAV) gene therapy product, for the treatment of neovascular age-related macular degeneration (nAMD). |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FT-003 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05611424 ↗ |
| Route | Other | “Administered via intraocular injection.” NCT05611424 ↗ |