Approval Probability
TA Base Rate
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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 the treatment of center involved diabetic macular edema (DME), a complication of diabetes that causes swelling in the central part of the retina. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
OCU200 targets integrin receptors, which are cell surface proteins involved in cell adhesion and signaling. By modulating these receptors, the drug aims to address the underlying pathology of diabetic macular edema. This mechanism is being evaluated in early-stage clinical trials for safety and efficacy.
OCU200 is being developed by Ocugen, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol OCGN. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and efficacy in patients with center involved diabetic macular edema.
OCU200 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory body. The ongoing Phase 1 study is designed to assess the safety and efficacy of OCU200 in patients with center involved diabetic macular edema.
OCU200 is being evaluated in a Phase 1 clinical trial registered as NCT05802329, titled "Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)." The study is actively recruiting participants in the United States and aims to enroll 24 patients.
No alternative names for OCU200 have been reported. The drug is identified solely by its code name OCU200 in clinical trial registries and scientific literature. It is a distinct investigational agent being developed by Ocugen, Inc. for diabetic macular edema.