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.
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“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.
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