OKYO Pharma Ltd (NASDAQ:OKYO) announced that the US Food and Drug Administration has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP), a chronic ocular condition with no FDA-approved therapies.
The designation is intended to expedite the development and review of drugs targeting serious conditions with unmet medical needs.
It offers benefits such as more frequent interactions with the FDA, eligibility for Accelerated Approval and Priority Review, and the potential for a Rolling Review of the New Drug Application.
"We are thrilled with the FDA's Fast Track designation for urcosimod in the treatment of neuropathic corneal pain,” OKYO Pharma CEO Dr Gary Jacob said in a statement.
“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.”
Urcosimod, previously known as OK-101, is being developed by OKYO Pharma as a non-opioid treatment for NCP, which is caused by nerve damage and leads to persistent and often severe eye pain.