OKYO Pharma Ltd (NASDAQ:OKYO) announced that it has filed a Fast Track designation application with the US Food and Drug Administration (FDA) for urcosimod, for the treatment of neuropathic corneal pain (NCP).
The FDA's Fast Track designation is intended to accelerate the development and review of treatments for serious conditions with unmet medical needs, potentially expediting urcosimod's path to market if it is granted.
NCP is a chronic and debilitating eye condition for which there is no FDA-approved therapy. The disorder causes severe eye discomfort and is currently managed through off-label treatments.
“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,” OKYO Pharma Dr Gary Jacob said in a statement.
“It is our belief that urcosimod has the potential to redefine the treatment paradigm for individuals grappling with this challenging condition.”
Urcosimod, formerly known as OK-101, is designed to address inflammation and pain linked to NCP. The drug has already demonstrated promising results in a Phase 2 trial for dry eye disease and is currently being evaluated in a Phase 2 trial for NCP involving 48 patients.