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Also known as dexamethasone ophthalmic suspension eye drops
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 ocular inflammation and eye pain following cataract surgery, as well as for uveitis related cystoid macular edema. It is formulated as an eyedrop and is currently in clinical development for these ophthalmology indications.
OCS-01 targets dexamethasone, a corticosteroid receptor agonist. It is designed to deliver dexamethasone directly to the eye to reduce inflammation and pain. The drug is being evaluated for its efficacy and safety in treating postoperative ocular inflammation and uveitis related macular edema.
OCS-01 is being developed by Oculis Holding AG, a biopharmaceutical company focused on ophthalmology. The company's stock is listed under the ticker symbol OCS. Oculis is advancing OCS-01 through clinical trials for multiple eye conditions.
OCS-01 is in Phase 3 clinical development. A Phase 3 study evaluating the drug for ocular inflammation and pain following cataract surgery has been completed. Additionally, a Phase 2 study for uveitis related and post surgical macular edema is active but not recruiting participants.
OCS-01 has been studied in two clinical trials. NCT05147233 is a completed Phase 3 study with 241 participants evaluating the drug for ocular inflammation and pain after cataract surgery. NCT05608837 is an active Phase 2 study with 28 participants for uveitis related and postoperative cystoid macular edema.
OCS-01 is not FDA approved. It is an investigational drug currently in clinical development. A Phase 3 trial for postoperative ocular inflammation and pain has been completed, and a Phase 2 trial for uveitis related macular edema is ongoing, but the drug has not yet received regulatory approval.