OKYO Pharma Reports First Patient Visit For Phase 2 Trial Of OK-101, To Fulfill One Of The Two Phase 3 Studies Required For FDA Approval If Successful

OKYO Pharma Limited OKYO OKYO announced that the first patient has been screened for its phase 2, multicenter, randomized, double-blinded, placebo-controlled trial, evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with dry eye disease (DED).  

“The initiation of this trial of topically applied OK-101 to treat dry eye disease marks a significant step for the company as we have been laser-focused on moving this drug candidate into clinical trials over the last 18 months,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “Importantly, this first clinical study is designed to include pre-specified primary efficacy endpoints, which are the hallmark of phase 3 registration trials and the results from this trial are anticipated before the end of this year.  The drug has been shown in pre-clinical studies to have potent anti-inflammatory and neuropathic corneal pain activities, and we are eager to evaluate its potential benefits in the clinic.”

“One of the most exciting aspects of this innovative clinical program is that we can get a rapid and informative answer on both safety and efficacy of OK-101 by the end of the year,” said Gabriele Cerrone, Executive Chairman and Founder of OKYO Pharma. “Furthermore, positive results would allow us to expedite the program towards FDA approval by leveraging results from this phase 2 dry eye trial in lieu of one of the two required phase 3 trials needed to support U.S. marketing authorization. OKYO remains well-positioned as novel ophthalmic compounds in large markets represent promising acquisition targets as evidenced by the recent $5.9 billion Iveric deal.”

Dry eye disease is a common condition that occurs when an individual’s tears are unable to adequately lubricate the eyes. This condition affects approximately 49 million people in the U.S. alone and has been a difficult one to positively diagnose and to 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. 

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