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OCU410ST · 1 trial · 1 indication
Change in the area of atrophy will be evaluated from the baseline measurements, using FAF to assess the loss of retinal layers.
Safety will be determined by the number of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
| Arm | Type | Description |
|---|---|---|
| Phase 2/3 Randomized Treatment Arm | EXPERIMENTAL | Subjects will receive a single subretinal injection of 200uL OCU410ST in concentration of 1.5 x 10E11vg/mL |
| Phase 2/3 Randomized Control Arm | NO_INTERVENTION | Subjects will not receive any active study intervention |
| Name | Type | Description |
|---|---|---|
| OCU410ST | DRUG | Subretinal Administration of OCU410ST |
Phase 2/3 Inclusion Criteria (applicable for both adult and pediatric subjects): 1. Males or females aged ≥5 years at the time of consent. 2. Subjects who have confirmed clinical and CLIA certified or equivalent genetic diagnosis of Stargardt disease (including ABCA4 related retinopathies). 3. Adul...
OCU410ST is an investigational small molecule being developed for the treatment of Stargardt Disease, a rare inherited retinal disorder. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in a Phase 2/3 trial in the United States.
OCU410ST is being developed by Ocugen, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol OCGN. The company is conducting a Phase 2/3 clinical trial of OCU410ST for Stargardt Disease in the United States.
OCU410ST is currently in Phase 2 clinical development. It is being evaluated in a Phase 2/3 trial for Stargardt Disease, which is active but not recruiting participants. The drug has not been approved by the FDA and remains investigational.
OCU410ST is being studied in a single clinical trial with the identifier NCT05956626, titled 'A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease.' The trial is active but not recruiting, with an enrollment of 51 participants in the United States.
OCU410ST has received Orphan Drug, Rare Pediatric Disease, and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA for the treatment of Stargardt Disease. These designations are intended to support the development of therapies for serious or life-threatening conditions.
Yes, the clinical trial for OCU410ST (NCT05956626) enrolls participants as young as 5 years old. The trial includes both male and female participants and is open to individuals with Stargardt Disease. The study is being conducted in the United States.