OKYO Pharma's (LON: OKYO) shares jumped 20% in early Thursday trading, hitting 2.7p per share after the company announced its Investigational New Drug (IND) application has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase 2 clinical study of OK-101 for the treatment of dry eye disease (DED).
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Despite the rise, OKYO's shares are down 61% in 2022.
“We are very pleased to receive clearance from the FDA to initiate our OK-101 Phase 2 study,” said Gary Jacob, Chief Executive Officer of OKYO Pharma. “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.”
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Following previous feedback from the FDA, the company said that they are designating primary and secondary efficacy endpoints in the Phase 2 study of OK-101, which includes a sign and a symptom of the disease.
In addition, the company believes that if its Phase 2 study meets its primary endpoint, it could accelerate the timeline to a new drug application (NDA) filing for OK-101.
“The clearance of our IND for OK-101 has been a key priority for the company this past year, and we are excited to be moving this drug into the clinic in the first quarter of 2023,” Jacob added.
YOUR CAPITAL IS AT RISK. 76% OF RETAIL CFD ACCOUNTS LOSE MONEY.