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Urcosimod · 1 trial · 1 indication
Evaluate the efficacy and safety of urcosimod 0.05% as compared to placebo instilled 4 times/day in participants who have a documented ocular history of symptoms of neuropathic corneal pain.
| Arm | Type | Description |
|---|---|---|
| Urcosimod Ophthalmic Solution | EXPERIMENTAL | • Urcosimod 0.05% - one drop in affected eye(s), four times a day |
| Vehicle ophthalmic solution | PLACEBO_COMPARATOR | Vehicle - one drop in affected eye(s), four times a day. |
| Name | Type | Description |
|---|---|---|
| Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks. | DRUG | Topical ophthalmic solution, applied as 1 drop QID in affected eye(s)\* for the 12-week Treatment Period |
| Vehicle Ophthalmic Solution | OTHER | Vehicle solution of the study drug (without active ingredient); preservative-free topical ophthalmic solution supplied in unit-dose ampoules; administered QID for 12-weeks. |
Inclusion Criteria: 1. Aged 18 years of age or older. 2. Able and willing to provide written informed consent prior to any study-related procedures. 3. Presence of symptoms of neuropathic corneal pain for at least 3 months defined as the presence of ocular pain associated or not with ocular symptom...
Urcosimod is an investigational ophthalmic solution being developed for neuropathic corneal pain, a condition involving persistent eye pain. It is a preservative-free topical product supplied in unit dose ampoules and is administered four times daily (QID) over a 12-week treatment period.
Urcosimod is being developed by OKYO Pharma Limited, which trades under the ticker OKYO. The company is advancing the ophthalmic solution for neuropathic corneal pain, a neurology-related therapeutic area, with the product currently in Phase 3 clinical development.
Urcosimod is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 program is evaluating the safety and efficacy of Urcosimod ophthalmic solution in participants with neuropathic corneal pain.
Urcosimod is being studied in one active Phase 3 trial, NCT07838506, titled a Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of Urcosimod Ophthalmic Solution in Participants With Neuropathic Corneal Pain. The trial plans to enroll 111 participants in the United States and is not yet recruiting.
Urcosimod has received Fast Track designation from the FDA. Fast Track is intended to facilitate development and expedite review of drugs addressing serious conditions with unmet medical need. Urcosimod remains investigational and is in Phase 3 development for neuropathic corneal pain.
Urcosimod is a preservative-free topical ophthalmic product supplied in unit dose ampoules. It is administered four times daily (QID) for a 12-week period. The Phase 3 trial NCT07838506 is evaluating this dosing regimen in participants with neuropathic corneal pain.