OKYO Pharma Completes Enrollment in Phase 2 Clinical Trial of OK-101 to treat Dry Eye Disease
Tuesday, September 12, 2023
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 (“NCP”), a severe ocular condition with no FDA approved therapy, is pleased to announce that it has completed full enrollment of patients in the randomized portion of the Phase 2 multi-center, double-masked, placebo-controlled clinical trial of topical ocular OK-101 to treat DED. A total of 240 patients have been enrolled in the study.
"This trial began in May of this year, and we have been pleased with the rapid pace of enrollment in the trial which has been managed by our clinical development partner Ora Inc., a world leader in dry eye clinical research,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “We now have 240 patients enrolled in the trial and 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.”
“The Phase 2 clinical trial is a crucial step in the development of OK-101, evaluating its safety, efficacy, and tolerability in the population of 240 DED patients comprising the study,” said Raj Patil, Ph.D., CSO of OKYO Pharma. “We remain committed to establishing the potential of this drug to treat the many millions of people currently suffering from DED."
DED 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. Several 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.
About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory DED) and NCP, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat inflammatory DED and ocular pain. OKYO presently has a 240-patient phase 2 trial of OK-101 underway to treat patients with DED, and also has plans underway for the opening of a 40-patient trial of OK-101 to treat NCP in patients with this debilitating condition. For further information, please visit www.okyopharma.com.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements, including with respect to the anticipated timing of completion of enrolment of the Company’s Phase 2 trial of topical ocular OK-101 to treat DED and the release of top-line data therefrom. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
Enquiries:
OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer U.S. 917-497-7560
Investor Relations Paul Spencer +44 (0)20 7495 2379
