FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain
- Fast Track designation received from FDA, potentially accelerating drug development and review process
- Multiple regulatory benefits including eligibility for Accelerated Approval and Priority Review
- Targeting an unmet medical need with no current FDA-approved treatments
- Potential first-mover advantage in the neuropathic corneal pain treatment market
- Drug is still in development phase with no guaranteed approval
- Timeline to market and potential commercialization remains uncertain
Insights
FDA Fast Track designation gives OKYO's NCP drug significant regulatory advantages, accelerating potential market entry for an unmet need.
The Fast Track designation granted to urcosimod represents a significant regulatory milestone that substantively enhances OKYO Pharma's development pathway. This designation is not awarded lightly—the FDA reserves it specifically for therapies addressing serious conditions with significant unmet medical needs, validating both the severity of neuropathic corneal pain and the current therapeutic void.
The tangible benefits this designation provides include more frequent FDA interactions, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and potentially a Rolling Review of their New Drug Application. These advantages can meaningfully compress development timelines—potentially by months or even years—creating a streamlined path toward possible commercialization.
For a specialized company like OKYO, this designation adds substantial credibility to their development program and strengthens their position with potential investors and strategic partners. While Fast Track status doesn't guarantee ultimate approval, it signals the FDA's preliminary confidence in urcosimod's potential and acknowledges the compelling need for effective NCP treatments.
This regulatory advantage positions OKYO to potentially introduce what could be a first-in-class therapy to a patient population currently lacking FDA-approved treatment options, giving them a significant competitive edge in addressing this ophthalmological condition.
FDA recognizes urgent need for NCP treatment through Fast Track designation, offering hope to patients suffering from this debilitating condition.
Neuropathic corneal pain (NCP) represents one of the most challenging and underserved conditions in clinical ophthalmology. This chronic, debilitating disorder causes persistent and often severe eye pain resulting from corneal nerve damage, substantially impacting patients' quality of life. The condition lacks FDA-approved therapies, leaving clinicians with limited and often suboptimal management approaches.
OKYO's urcosimod receiving Fast Track designation is particularly significant because it indicates the FDA recognizes both the seriousness of NCP and the promising potential of this therapeutic approach. For ophthalmologists managing patients with this challenging condition, having a targeted therapy would represent a paradigm shift from current symptomatic management strategies.
While the press release doesn't detail urcosimod's mechanism of action, the Fast Track designation suggests the drug has demonstrated sufficient promise to warrant expedited development and review. For context, many NCP patients experience symptoms that persist despite conventional treatments, leading to disability, decreased productivity, and significant psychological burden.
The accelerated development pathway now available to OKYO could substantially reduce the time before ophthalmologists have access to a specifically indicated treatment option, potentially transforming the management approach for a condition that has historically been extremely difficult to treat effectively.
LONDON and NEW YORK, May 01, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod (formerly called OK-101) to treat NCP, an ocular condition associated with chronic and often severe pain but without an FDA-approved therapy, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP).
Fast Track designation by the FDA is granted to facilitate the development and expedite the review of therapies that aim to treat serious conditions and fulfill unmet medical needs. This designation is intended to accelerate the availability of new treatments to patients, providing earlier access to potentially beneficial therapies. The Fast Track designation provides several key benefits, including more frequent meetings with the FDA to discuss the drug’s development plan, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and a potential Rolling Review of the New Drug Application (NDA).
Neuropathic corneal pain is a debilitating condition characterized by persistent, severe eye pain caused by nerve damage, impacting a significant number of patients worldwide. OKYO Pharma's urcosimod aims to address this urgent medical need with its innovative approach.
Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma, expressed his enthusiasm about the FDA's decision: "We are thrilled with the FDA's Fast Track designation for urcosimod in the treatment of neuropathic corneal pain. This milestone underscores our commitment to advancing innovative therapies that can make a meaningful difference in patients' lives. We look forward to working closely with the FDA to bring this promising treatment to patients as quickly as possible."
OKYO Pharma remains dedicated to advancing urcosimod through clinical development and regulatory review, with a focus on addressing the significant unmet medical need in neuropathic corneal pain treatment.
About NCP
Neuropathic corneal pain is a condition that causes severe pain and sensitivity of the eyes, face, or head. The exact cause of neuropathic corneal pain is unknown but is thought to result from nerve damage to the cornea combined with inflammation. Neuropathic corneal pain, which can exhibit as a severe, chronic, debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments in an off-label fashion. Notably, there is no FDA approved drug to treat this debilitating condition.
About the Urcosimod Phase 2 Trial in NCP Patients
The Phase 2 study was designed as a double-masked, randomized, 12-week placebo-controlled trial in NCP patients, with disease confirmed via confocal microscopy.
About Urcosimod (Formerly called OK-101)
Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to potentially enhance the residence time of urcosimod within the ocular environment. Urcosimod showed clear statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease, and was also being evaluated in a randomized, placebo-controlled, double-masked Phase 2 trial to treat neuropathic corneal pain patients.
About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain and dry eye disease, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and dry eye disease. In addition to the completed Phase 2 trial of urcosimod to treat dry eye disease patients, OKYO is also currently evaluating urcosimod to treat neuropathic corneal pain patients.
For further information, please visit www.okyopharma.com.
Enquiries:
| OKYO Pharma Limited | Gary S. Jacob, Chief Executive Officer | 917-497-7560 |
| Business Development & Investor Relations | Paul Spencer | +44 (0)20 7495 2379 |
FAQ
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