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Okyo Pharma Ltd - London-based ophthalmology-focused bio-pharmaceutical company - Receives clearance of its investigational new drug application from the US Food & Drug Administration to begin a phase two first-in-human clinical study of OK-101 for the treatment dry eye disease.
‘We are very pleased to receive clearance from the FDA to initiate our OK-101 Phase 2 study. We believe this first-in-human study will help demonstrate that OK-101 may provide a new way to treat DED patients who are not well-served by currently approved drugs. Based on earlier feedback from the FDA we are designating primary and secondary efficacy endpoints in this study that include both a sign and a symptom of the disease. Should our Phase 2 study meet its pre-specified primary endpoint, it may accelerate the timeline to a new drug application filing for OK-101 with the FDA,’ says Chief Executive Gary Jacob.
Current stock price: 2.57 pence, closing 14% higher on Thursday in London
12-month change: down 64%
By Heather Rydings, Alliance News senior economics reporter
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