OKYO Pharma seeks FDA Fast Track for eye pain drug

OKYO Pharma Ltd (NASDAQ:OKYO), a biopharmaceutical company valued at $48.53 million, has announced today its submission for Fast Track designation with the U.S. Food and Drug Administration (FDA) for its investigational drug, urcosimod, aimed at treating neuropathic corneal pain. This condition, affecting tens of thousands globally, is characterized by chronic and intense eye discomfort and currently lacks an FDA-approved effective treatment. The company’s stock has shown strong momentum, gaining over 13% in the past week, according to InvestingPro data.

The company’s application, filed today, represents a significant step towards expediting the development and review process for urcosimod, previously referred to as OK-101. If granted, the Fast Track designation could facilitate a quicker pathway to potential approval, addressing the urgent need for treatment options in this patient population. While the company currently operates at a loss with an EBITDA of -$10.35 million, InvestingPro analysis reveals 8 additional key insights about the company’s financial health and market position.

According to the press release, neuropathic corneal pain is a debilitating eye condition that causes severe discomfort and can significantly impact the quality of life for sufferers. The lack of approved treatments for this condition underscores the importance of OKYO Pharma’s application for Fast Track designation.

The Fast Track program is designed to accelerate the development and review of drugs intended to treat serious conditions with unmet medical needs. A Fast Track drug may be eligible for more frequent meetings and communications with the FDA, rolling review of the New Drug Application (NDA), and potentially priority review to expedite the approval process.

OKYO Pharma’s Chief Financial Officer, Keeren Shah, signed off on the report, ensuring the company’s compliance with the Securities Exchange Act of 1934. The information contained in the report, including the news announcement dated today, is furnished and will not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, nor will it be incorporated by reference in any filing under the Securities Act of 1933, as amended.

This development is notable for investors and patients alike, as it may lead to new treatment avenues for a currently underserved medical condition. With a current ratio of 0.28 and trading near its 52-week high of $1.90, the company faces both opportunities and challenges in its development path. The company’s progress will be closely monitored as the FDA reviews their application for Fast Track designation. The information in this article is based on a press release statement and financial data from InvestingPro.

In other recent news, OKYO Pharma Ltd. announced that its lead drug candidate, previously known as OK-101, has been officially named "urcosimod" by the United States Adopted Name (USAN) Council. This development marks a significant milestone in the drug’s progression through clinical trials, particularly for treating neuropathic corneal pain (NCP) and dry eye disease (DED). H.C. Wainwright has maintained its Buy rating on OKYO Pharma, with a price target of $7.00, indicating confidence in the company’s ongoing clinical developments. The firm highlighted the promising results from a Phase 2 trial for DED, which showed significant improvements in symptoms such as stinging and burning.

OKYO Pharma is actively conducting a Phase 2 trial for NCP, with topline results expected in the fourth quarter of 2025. This study is a double-masked, randomized, placebo-controlled trial assessing the efficacy of urcosimod. Additionally, insider activity has been reported, with CEO Gary S. Jacob and Panetta Partners Limited acquiring shares, potentially signaling confidence in the company’s prospects. The insider purchases align with OKYO Pharma’s focus on addressing the unmet needs in the ocular treatment market. These developments underscore the company’s commitment to advancing its drug pipeline and enhancing treatment options for eye diseases.

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