OKYO Pharma Limited (OKYO) said the U.S. FDA has authorized a single-patient expanded access, or compassionate-use, IND for Urcosimod 0.05% to treat a patient with severe neuropathic corneal pain (NCP). The request was submitted by Pedram Hamrah, MD, at the University of South Florida, for a patient with debilitating symptoms and no effective treatment options.
Neuropathic corneal pain is a chronic and often severe condition involving nerve dysfunction and inflammation of the cornea. There are currently no FDA-approved therapies specifically for NCP, leaving patients reliant on off-label treatments that often provide limited relief.
Under the FDA-authorized expanded-access program, Urcosimod will be provided for use in a patient with severe NCP who has exhausted available alternatives. OKYO noted that the drug's proposed dual mechanism- targeting both inflammatory pathways and nerve-related pain signaling- supports its evaluation in this setting.
Urcosimod, formerly known as OK-101, has shown anti-inflammatory and pain-reducing activity in preclinical models and recently produced positive results in a randomized Phase 2 trial in NCP patients. The company plans to initiate a 120-patient Phase 2b/3 multiple-dose study later this year.
OKYO has traded between $0.90 and $3.34 over the past year. The stock closed yesterday's trading at $2.37, up 13.94% and is currently trading in the pre-market at $2.43, up 2.53%.
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