OKYO Pharma Achieves 90% Enrollment in 240-Patient Phase 2 Clinical Trial of OK-101 to treat Dry Eye Disease (“DED”)

• Full enrollment anticipated by first week of September
• OKYO on schedule to release top-line data before end of 2023
• Phase 2 trial is designed as potential registration trial with pre-specified primary efficacy endpoints covering both a sign and symptom of DED
  

LONDON and NEW YORK, Aug. 30, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to treat DED to address the significant unmet need in this multi-billion-dollar market, is pleased to announce that it has enrolled and randomized 90% of the patients in its 240-patient Phase 2 multi-center, double-masked, placebo-controlled clinical trial of topical ocular OK-101 to treat DED.

"We are very pleased at the rapid pace of enrollment we are seeing in our ongoing Phase 2 trial of our flagship drug OK-101 to treat patients with DED. This trial began in May of this year, with the first patient being randomized in June into one of the three cohorts. Having enrolled 90% of the patients in this trial is an important milestone for OKYO Pharma,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “We presently have 216 patients enrolled in the trial and are anticipating completing full enrollment by the first week in September. Moreover, the pace at which we are enrolling patients has been encouraging in moving us toward our planned release of top-line data by end of 4Q 2023.”

“The Phase 2 clinical trial is a crucial step in the development of OK-101, evaluating its safety, efficacy, and tolerability in a larger patient population. We sincerely appreciate the clinicians and staff that are contributing to the conduct of this trial and are extremely grateful to the patients that have chosen to participate,” said Raj Patil, Ph.D., CSO of OKYO Pharma. “The Company remains laser focused on completing the trial, which is managed by our clinical development partner Ora Inc. a world leader in dry eye clinical research, and is committed to establishing the potential of this drug to treat the many millions of people currently suffering from DED."

Dry eye disease is a common condition that occurs when one’s tears are unable to adequately lubricate the eyes. This condition affects approximately 49 million people in the United States alone and has been difficult to positively diagnose and treat due to the multifactorial nature of the condition. A number of contributing factors can lead to this condition, including age, sex, certain medical conditions, reduced tear production and tear film dysfunction. Tear film instability typically leads to inflammation and damage to the ocular surface and pain.