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OKYO Pharma Ltd, a biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has awarded Fast Track designation to its product, urcosimod, for the treatment of neuropathic corneal pain (NCP). The designation, intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need, was confirmed today, Thursday.
The company, which specializes in biological products, disclosed the FDA’s decision in a Form 6-K filed with the Securities and Exchange Commission. Fast Track status is expected to enhance the company’s ability to bring urcosimod to patients who suffer from NCP, a condition for which there are currently limited treatment options.
The Fast Track designation by the FDA is significant as it is indicative of the agency’s recognition of the potential benefits of urcosimod in addressing a critical and undersigned area of patient care. The company’s announcement was made public through Exhibit 99.1 attached to the Form 6-K report, which specifies that the information provided is to be considered furnished and not filed, meaning it is not subject to the liabilities of Section 18 of the Securities Exchange Act of 1934.
OKYO Pharma Ltd, with its principal executive office located in London, is obliged to file annual reports under the cover of Form 20-F, as indicated in the 6-K filing. The report was signed by Keeren Shah, the Chief Financial Officer of OKYO Pharma Ltd.
This development marks a potentially important step forward for OKYO Pharma and for patients suffering from neuropathic corneal pain, a condition that can significantly affect the quality of life. The Fast Track designation may lead to a more efficient review process, potentially bringing urcosimod to market more quickly. The information in this article is based on a press release statement.
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