OKYO Pharma Seeks FDA Fast Track for Urcosimod

OKYO Pharma has officially filed an application with the U.S. Food and Drug Administration (FDA) seeking Fast Track designation for urcosimod (formerly known as OK-101) as a potential treatment for neuropathic corneal pain (NCP).

Significance of Fast Track Designation

Fast Track designation is granted by the FDA to accelerate the development and review of drugs intended to treat serious conditions that currently lack FDA-approved treatment options. Neuropathic corneal pain falls within this category, making urcosimod a promising candidate for expedited regulatory consideration.

Gary S. Jacob, PhD, CEO of OKYO Pharma, emphasized the importance of this milestone in a company press release:

“Fast track was first introduced by FDA to expedite development and review of drugs to treat serious conditions lacking any FDA-approved drug. Notably, neuropathic corneal pain falls into this category, and our application for Fast Track designation marks a significant milestone in our commitment to addressing the urgent needs of patients suffering from this type of pain. It is our belief that urcosimod has the potential to redefine the treatment paradigm for individuals grappling with this challenging condition.”

Advantages of Fast Track Designation

If granted, Fast Track designation will provide OKYO Pharma with several regulatory benefits, including:

• More frequent meetings with the FDA to discuss the drug’s development strategy.

• Assurance that the necessary data is collected to support drug approval.

• Eligibility for rolling review, allowing sections of the New Drug Application (NDA) to be reviewed as they are completed, potentially expediting the approval process.

Understanding Neuropathic Corneal Pain

Neuropathic corneal pain is a severe and often debilitating condition characterized by chronic eye pain and heightened sensitivity in the eyes, face, or head. While the exact cause of NCP remains unknown, it is believed to stem from nerve damage to the cornea combined with underlying inflammation. Currently, no FDA-approved treatments exist for this condition, underscoring the urgent need for innovative therapeutic solutions.

Urcosimod’s Mechanism and Clinical Progress

Urcosimod is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor, which is predominantly expressed on immune cells involved in the ocular inflammatory response.

• In a recently completed Phase 2, multi-center, double-masked, placebo-controlled trial for dry eye disease, urcosimod demonstrated statistically significant efficacy across multiple endpoints.

• The drug is currently undergoing evaluation in a randomized, placebo-controlled, double-masked Phase 2 trial involving 48 neuropathic corneal pain patients.

The Evolution from OK-101 to Urcosimod

OKYO Pharma recently announced the adoption of the United States Adopted Name (USAN) urcosimod, replacing the previous designation OK-101. The suffix "-mod" in urcosimod signifies its classification as a modulator of key inflammatory and neuropathic pathways, positioning it as a promising treatment for neuropathic corneal pain and dry eye disease.

Conclusion

OKYO Pharma's pursuit of Fast Track designation for urcosimod represents a critical step in the advancement of innovative therapies for neuropathic corneal pain. With no approved treatment currently available, the expedited development of urcosimod could offer new hope to patients struggling with this challenging condition.