Okyo Pharma Limited announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP), a debilitating condition characterized by persistent, severe eye pain caused by nerve damage.
In a press release, Okyo Pharma said it 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.
The Urcosimod phase 2 trial in NCP patients was designed as a double-masked, randomized, 12-week placebo-controlled trial with disease confirmed via confocal microscopy, the company said.
"We are thrilled with the FDA's Fast Track designation for urcosimod in the treatment of neuropathic corneal pain," said Gary S. Jacob, PhD, chief executive officer of Okyo Pharma, in the press release. "We look forward to working closely with the FDA to bring this promising treatment to patients as quickly as possible."