OKYO Pharma Ltd (NASDAQ:OKYO) earlier this week confirmed it is set to launch a Phase 2b/3 clinical trial for neuropathic corneal pain, following a productive Type C meeting with the US Food and Drug Administration (FDA).
In a conversation with Proactive, chief executive Robert Dempsey said the regulatory meeting provided "a clear line of sight" for advancing the programme, which targets a condition he described as severely debilitating and significantly underserved.
Proactive: Welcome back inside our Proactive newsroom. And joining me now is Robert Dempsey. He is the CEO of Okyo Pharma. And Robert, it's great to see you again. How are you?
Robert Dempsey: I'm doing very well, thank you. We survived the storm up here in Boston. We're also very excited coming off the heels of our successful FDA meeting that was completed yesterday.
Absolutely. Last time you and I chatted, you mentioned you were looking forward to the FDA meeting to get some guidance. It was a Type C meeting — can you explain what that means and what the FDA had to say?
Yes. It’s an opportunity for us to engage the FDA. We sent them a list of questions as we were preparing for our Phase 2b/3 study. This included critical components like the primary endpoint, CMC (manufacturing), and the statistical plan. We also used the meeting to highlight the significant unmet need in neuropathic corneal pain. With the written comments and opportunity to ask more questions, we now have a clear line of sight to activate our Phase 2b/3 clinical study.
Was there anything that surprised you in the meeting, or did it go as expected?
Anytime you meet with the agency, you're always on the lookout for surprises. Fortunately, there were none. The team was highly prepared and well-organized. The feedback from the agency to move straight forward into our clinical study was very positive.
What are the next steps now that you’ve received this guidance?
We need to finalize site selection and budget. We now have guidance to enroll 120 subjects and clarity on the primary endpoint, so we can finalize the protocol. After that, we’ll initiate discussions with sites and refine our timeline. The goal is first patient, first visit by mid-year. If we hit that, we can complete the study by year-end and aim for top-line results in Q1 2027. This year is all about clinical execution.
And ultimately, this is about helping people suffering from a very painful condition.
Absolutely. What’s been eye-opening is hearing directly from patients. They’ve reached out to us through our information portal and described the condition and how it severely impacts their quality of life. That motivates us. We have a unique opportunity to make a difference and get this drug into physicians’ hands.
Quotes have been edited for clarity and style