OKYO Pharma to Release New and Comprehensive Data from Phase 2 Dry Eye Disease Trial and Host Key Opinion Leader Event

LONDON and NEW YORK, March 20, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announces that it will be releasing new and comprehensive efficacy data readout from the Phase 2 trial of OK-101 in dry eye disease on March 22, 2024. The company will also host a Key Opinion Leader (KOL) event to discuss the findings in depth.

In a previous preliminary data readout, OK-101 showed statistically significant drug effects in FDA-recognized efficacy endpoints as early as the 15-day first visit after dosing. Additionally, statistically significant improvements were observed in both a “sign” (total conjunctival staining) and two “symptoms” (burning/stinging and blurred vision), which are FDA-recognized endpoints of dry eye disease.

The KOL call will feature prominent experts in the field of dry eye disease. The speakers will provide insights regarding the clinical significance of the OK-101 Phase 2 findings and discuss the potential implications for patient care and future research endeavors in DED.

“The upcoming data release follows the successful completion of OKYO Pharma's Phase 2 trial, which focused on assessing the efficacy and safety of OK-101, our novel topical therapeutic candidate for dry eye disease,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “We plan to advance OK-101 into Phase 3 clinical trials in 2024, with the goal of developing a highly differentiated dry eye product to help patients underserved by current treatments. Our parallel development focus for OK-101 in 2024 is the evaluation of this drug candidate to treat neuropathic corneal pain for which we have already received IND clearance to begin clinical studies.”

OK-101 Phase 2 Trial in DED Patients
The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with DED dosed twice-daily (BID). Patients were randomly divided into 3 cohorts, with one of the cohorts dosed with 0.05% OK-101 (n=81), a second with 0.1% OK-101 (n=80), and the third cohort with vehicle (n=79). The duration of a patient’s treatment was 14 weeks, including a 2-week run-in period on placebo, to exclude placebo responders from the study, followed by 12 weeks in the randomized portion of the study.