Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OCS-01 · 2 trials · 4 indications
Mean change in central subfield thickness (CST) on optical coherence tomography (OCT) at week 12 compared to baseline.
Mean change in early treatment of diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score at week 12
| Arm | Type | Description |
|---|---|---|
| High Dose UME - 6 drops OCS-01 | EXPERIMENTAL | From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day. At week 4, participants randomized to the high dose group will continue to receive 01 drop of OCS-01 six times a day until the primary end point at week 12. Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24. |
| Low Dose UME 3 drops OCS-01 and 3 drops Placebo | EXPERIMENTAL | From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day. At week 4, the participants randomized to low dose group will receive 01 drop of OCS-01 three times a day and 01 drop of placebo three times a day,( total 6 drops each day) until the primary end point at week 12. Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24. |
| High dose PSME - 6 drops of OCS-01 | EXPERIMENTAL | From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day. At week 4, participants randomized to the high dose group will continue to receive 01 drop of OCS-01 six times a day until the primary end point at week 12. Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24. |
| Low dose PSME - 3 drops of OCS-01 and 3 drops of Placebo | EXPERIMENTAL | From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day. At week 4, the participants randomized to low dose group will receive 01 drop of OCS-01 three times a day and 01 drop of placebo three times a day, (total 6 drops each day) until the primary end point at week 12. Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24. |
| Name | Type | Description |
|---|---|---|
| OCS-01 | DRUG | Dexamethasone ophthalmic suspension, 1.5% |
| Vehicle | DRUG | Vehicle |
Inclusion Criteria: 1. Age 18 years or older. 2. Diagnosis of Uveitic macular edema (UME) or post-surgical macular edema (PSME). 3. Can provide written informed consent prior to any study procedure being performed, able and willing to follow all instructions, and attend all study visits. 4. UME of ...
OCS-01 is an investigational small molecule being developed for ophthalmology indications, specifically for ocular inflammation and eye pain following cataract surgery, and for uveitis related cystoid macular edema. It is formulated as an eyedrop and is currently in clinical development.
OCS-01 is being developed by Oculis Holding AG, a biopharmaceutical company traded under the ticker OCS. The company is advancing the drug through clinical trials for ophthalmology indications.
OCS-01 is in Phase 3 clinical development. A Phase 3 study for ocular inflammation and pain following cataract surgery has been completed, and a Phase 2 study for uveitis related cystoid macular edema is active but not recruiting. It is not yet approved.
OCS-01 has been studied in NCT05147233, a completed Phase 3 trial for ocular inflammation and pain after cataract surgery with 241 participants, and NCT05608837, an active Phase 2 trial for uveitis related and post surgical macular edema with 28 participants in the United States.
OCS-01 is a small molecule eyedrop designed to treat ocular inflammation and pain. Its specific molecular target has not been disclosed, so its mechanism of action is not detailed here.