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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | ABBV-444, REFRESH OPTIVE UD |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Alcon AG | ALC | 1 | N/A | Undisclosed |
| Harrow, Inc. | HROW | 1 | - | Undisclosed |
OK-101 is an investigational small molecule being developed for the treatment of Dry Eye Disease. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied for its efficacy and safety in patients with this condition.
OK-101 is being developed by OKYO Pharma Limited, a biopharmaceutical company traded under the ticker symbol OKYO. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Dry Eye Disease.
OK-101 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. A Phase 2 clinical trial has been completed to evaluate its efficacy and safety in patients with Dry Eye Disease.
OK-101 has one completed Phase 2 clinical trial, identified as NCT05759208. This study evaluated the efficacy and safety of OK-101 in subjects with Dry Eye Disease. The trial enrolled 240 participants in the United States and was randomized, double-blind, and controlled.
No, OK-101 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Dry Eye Disease. A Phase 2 clinical trial has been completed, but the drug has not yet received regulatory approval.