Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OCU200 · 1 trial · 2 indications
Counts, frequencies and percentages of SDAEs.
Counts, frequencies and percentages TEAEs.
Counts, frequencies and percentages of SAEs.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 3+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration). |
| Cohort 2 | EXPERIMENTAL | 3+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration). |
| Cohort 3 | EXPERIMENTAL | 3+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration). |
| Cohort 4 | EXPERIMENTAL | 3+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration). |
| Name | Type | Description |
|---|---|---|
| OCU200 | DRUG | Intravitreal Injection |
Inclusion Criteria: 1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus 2. Decreased visual acuity attributable primarily to DME 3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of: 1. ≥ 320 but ≤...
OCU200 is an investigational small molecule being developed for center-involved diabetic macular edema (DME), a condition that causes vision loss due to fluid accumulation in the center of the retina. It is currently in Phase 1 clinical development and has not been approved by the FDA.
OCU200 is being developed by Ocugen, Inc., a biopharmaceutical company traded on NASDAQ under the ticker OCGN. The company is conducting a Phase 1 study to evaluate the safety and efficacy of OCU200 in patients with center-involved diabetic macular edema.
OCU200 is in Phase 1 clinical development. The ongoing Phase 1 study is recruiting participants in the United States and is designed to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema. The drug remains investigational and is not yet approved.
OCU200 is being studied in a Phase 1 trial registered as NCT05802329, titled "Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)." The trial is actively recruiting 24 participants in the United States and includes healthy volunteers.
OCU200 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for center-involved diabetic macular edema. The ongoing study is evaluating its safety and efficacy, and regulatory approval has not been granted.