OKYO Pharma Ltd (NASDAQ:OKYO) told investors it expects to see considerable enrollments of patients in the ongoing trial of its flagship drug OK-101 to treat dry eye disease (DED) this summer and is on track to release top-line data in the fourth quarter of 2023.
Announcing full-year 2023 results for the ophthalmology-focused bio-pharmaceutical company, CEO Gary Jacob commented: “We are very pleased at the advancements we have made with our flagship drug OK-101 to treat DED this year. On May 2, 2023, we announced the initiation of our first clinical trial of OK-101 to treat DED. This trial is a 240-patient, phase 2, multi-center, randomized, double-masked, placebo-controlled trial in patients with DED.”
Jacob also noted OKYO’s recent announcement of its plan to open a small trial of OK-101 to treat patients with neuropathic corneal pain (NCP) at Tufts Medical Center in Boston, using the drug’s dual combination of anti-inflammatory ocular activity and NCP-reducing activity.
NCP is a debilitating condition characterized by chronic and severe eye discomfort, leading to decreased quality of life for affected individuals. There is presently no US Food and Drug Administration (FDA)-approved drug to treat NCP.
The 40-patient open-label clinical trial will evaluate the efficacy and safety of OK-101 in patients with NCP. The Investigational New Drug (IND) application for NCP is planned to be filed in 4Q of 2023, with study enrollment planned to commence shortly after IND allowance by the FDA.
“We remain steadfast in our dedication to advancing groundbreaking ocular solutions that have the potential to transform patients' lives,” he added.
“We are actively exploring opportunities to optimize our operational efficiency and enhance our partnerships within the industry.”
For the year to March 31, 2023, the company reported a loss of $13.7 million compared to $6.3 million in 2022. Research and development expenses increased to $6.3 million, from $1.6 million, as it filed an IND for OK-101.
The company ended the year with $4 million in cash, up from $2.7 million a year earlier.
Contact the author at stephen.gunnion@proactiveinvestors.com