Approval Probability
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Adjusted LOA
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RGX-314 Dose 1 · 1 trial · 1 indication
To evaluate the effect of RGX-314 on BCVA at Week 52
| Arm | Type | Description |
|---|---|---|
| RGX-314 Treatment Arm (Dose 1) | EXPERIMENTAL | Genetic: RGX-314 Dose 1 \- AAV8 vector containing a transgene for anti-VEGF fab (Dose 1) |
| Treatment Arm (Dose 2) | EXPERIMENTAL | Genetic: RGX-314 Dose 2 -AAV8 vector containing a transgene for anti-VEGF fab (Dose 2) |
| Aflibercept Treatment Arm | ACTIVE_COMPARATOR | Biological: Aflibercept IVT * Commercially available Active Comparator * Other Names: Eylea |
| Name | Type | Description |
|---|---|---|
| RGX-314 Dose 1 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 1) |
| RGX-314 Dose 2 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 2) |
| Aflibercept (2.0 mg) | BIOLOGICAL | Commercially available Active Comparator |
Inclusion Criteria: * Type I or Type II diabetes mellitus with center involving diabetic macular edema with previous treatment * HbA1c ≤12% * BCVA in study eye 78 to 25 ETDRS letters (\~20/32 to 20/320) at screening * Decreased visual acuity attributable primarily due to CI - DME * Demonstrate clin...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
RGX-314 Dose 1 is an investigational gene therapy being studied for the treatment of diabetic macular edema (DME). It is currently in Phase 2 clinical development for this condition, which affects the center of the retina and can cause vision loss in adults.
RGX-314 Dose 1 is being developed by REGENXBIO Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol RGNX. The company is conducting clinical trials to evaluate the safety and efficacy of this gene therapy for diabetic macular edema.
RGX-314 Dose 1 is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for diabetic macular edema.
RGX-314 Dose 1 is being evaluated in a Phase 2 trial with the identifier NCT06942520. This randomized, active-controlled study is recruiting adults aged 25 years and older with center-involved diabetic macular edema in the United States, with a planned enrollment of 18 participants.
RGX-314 Dose 1 has received several FDA designations, including Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, Rare Pediatric Disease, Fast Track, Accelerated Approval, and Priority Review. These designations are intended to expedite the development and review of therapies for serious conditions.