OKYO Pharma Announces Positive Safety Data Profile for the ongoing OK-101 Phase 2 Clinical Trial to Treat Dry Eye Disease ("DED")

• Over 95% of randomized DED patients have completed 4 weeks of dosing in the planned 12-week Phase 2 trial, with 72% of randomized DED patients completing 8 weeks, and 7.1% of patients completing the entire 12-week trial.
• The dropout rate is 5.4% and unrelated to side effects.
• Top-line efficacy and safety data are on schedule for release in December 2023.

LONDON and NEW YORK, Oct. 05, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and for neuropathic corneal pain, a severe ocular condition without an FDA approved therapy, is pleased to announce that its first drug candidate OK-101, presently in a 240-patient double-blind placebo-controlled phase 2 trial in patients with DED is currently showing a positive safety profile in the ongoing study. Patients continue in the study, and double-blind procedures are still in effect until all patients complete the 12-week dosing duration. OKYO will continue to monitor the trial progress and the safety profile until the release of top-line data in December 2023.

The assignment of 240 DED patients to treatment is now complete, with 230 (95%) patients having completed 4 weeks of dosing, 174 patients (72%) completing 8 weeks of dosing, and 17 patients completing 12 weeks of dosing. OK-101 is well tolerated, with patients continuing on the trial without a dose change.

"The Phase 2 trial currently underway is focused on evaluating the safety and tolerability of OK-101, as well as its potential efficacy to treat patients with DED," said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. "A key need for any drug's approval is not only its efficacy in treating the disease but its tolerability, particularly for chronic conditions where drug dosing is anticipated to last for years. In that instance, the side effect profile becomes a major concern, and although it is early in our evaluation of OK-101 in the current Phase 2 trial, we are encouraged by what we are seeing with the administration of OK-101 to patients with DED. Furthermore, we are very pleased with the low level of dropouts we are seeing in this ongoing trial as well as the high 72% retention rate at 8 weeks. We recently announced having all 240 patients enrolled in the trial. We are anticipating the last-patient last-visit to occur in the last week of November 2023, with the planned release of top-line data occurring in December 2023."