Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OK-101 · 1 trial · 1 indication
Total corneal fluorescein staining score of the study eye using the Ora Calibra® scale, measured by mean change from baseline (Visit 2 pre-CAE®) to Day 85 (Visit 6). Each of the 5 areas will be scored on a scale of 0 to 4 for a total minimum score of 0 to total maximum score of 20, with 0 being best and 20 being worst.
Ocular discomfort score of both eyes using the Ora Calibra® scale, measured by mean change from baseline (Visit 2 pre-CAE®) to Day 85 (Visit 6). Each eye will be scored separately on a scale from 1 to 4, with 1 being best and 4 being worst.
| Arm | Type | Description |
|---|---|---|
| Placebo | EXPERIMENTAL | OK-101 Placebo Ophthalmic Solution (vehicle): 1 drop BID in each eye (N = \~80) |
| Low Dose OK-101 | EXPERIMENTAL | 0.05% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = \~80) |
| High-Dose OK-101 | EXPERIMENTAL | 0.1% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = \~80) |
| Name | Type | Description |
|---|---|---|
| OK-101 | DRUG | Ophthalmic Solution |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Be at least 18 years of age; 2. Provide written informed consent; 3. Be willing and able to comply with all study procedures; 4. Have a patient-reported history of dry eye for at least 6 months prior to Visit 1; 5. Have a history of use or desire to use eye drops for dry eye ...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-319 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Bausch Health Companies Inc. | BHC | 1 | PHASE2 | BL1107 |
OK-101 is being developed for the treatment of dry eye disease, an ophthalmology condition. It is a small molecule therapeutic candidate from OKYO Pharma Limited. The clinical program has focused on evaluating efficacy and safety in adults with dry eye disease, with one completed Phase 2 study conducted in the United States.
OK-101 targets ChemR23, a G-protein coupled receptor. By binding to this receptor, the small molecule is designed to act on pathways associated with ocular inflammation and tear production relevant to dry eye disease. ChemR23 is the only molecular target identified for OK-101 in its development program.
OK-101 is being developed by OKYO Pharma Limited, which trades under the ticker OKYO. The company is advancing the small molecule candidate in ophthalmology, specifically for dry eye disease. OKYO Pharma Limited is the sole developer listed for this asset.
OK-101 is in Phase 2 development. One Phase 2 trial has been completed, and there are currently no active trials listed for the program. OK-101 is investigational and has not been approved by the FDA for any indication.
OK-101 has been evaluated in one completed Phase 2 trial, NCT05759208, titled a study evaluating the efficacy and safety of OK-101 in subjects with dry eye disease. The trial enrolled 240 participants in the United States, was randomized, double-blind, and controlled, and included adults 18 years and older.