OKYO Pharma Receives Positive FDA Feedback for Urcosimod, Plans Global Phase 3 Trial for Neuropathic Corneal Pain

FDA Supports Next Step for Urcosimod Development

OKYO Pharma Limited has announced positive feedback from its Type D meeting with the US Food and Drug Administration (FDA), giving the company greater confidence as it prepares to move its investigational therapy, urcosimod, into a global Phase 3 clinical trial.

The FDA's response supports the company's regulatory strategy and clinical development plan for treating neuropathic corneal pain (NCP), a condition that currently has no FDA-approved therapies.

According to OKYO Pharma, the meeting marks an important milestone in the development of urcosimod and provides a clearer path toward potential regulatory approval.

Phase 3 Trial Design Receives Regulatory Validation

The FDA reviewed the design of OKYO Pharma's planned NEPTUNE Phase 3 clinical trial during the Type D meeting.

The company said the agency's feedback validates the proposed study design and helps reduce regulatory uncertainty moving forward.

Based on discussions with the FDA, OKYO Pharma now plans to position the NEPTUNE study as a pivotal clinical trial that could potentially support a single-trial registration strategy, provided the study delivers positive results and receives continued regulatory support.

This approach could help simplify the overall clinical development process.

Company Says Feedback Reduces Development Risk

Dr. Flavio Mantelli, Chief Medical Officer of OKYO Pharma, described the FDA meeting as an important step for the company.

He said the agency's comments provide regulatory validation for the Phase 3 study design while helping accelerate the clinical development program for urcosimod.

According to the company, this feedback also increases confidence that future clinical data will meet the expectations of physicians, regulators and patients.

Global Phase 3 Trial Now Becomes the Focus

Following the FDA meeting, OKYO Pharma plans to move directly into its global Phase 3 clinical study.

Chief Executive Officer Robert J. Dempsey said the company is financially prepared to support the next stage of development.

He added that the company remains focused on bringing a first-in-class, non-opioid treatment option to patients living with neuropathic corneal pain, where treatment choices remain extremely limited.

What Is Neuropathic Corneal Pain?

Neuropathic corneal pain is a chronic and often severe eye condition that causes persistent pain and extreme sensitivity in the eyes.

Some patients may also experience pain spreading to the face or head.

The condition is believed to develop when the sensory nerves in the cornea become damaged or stop functioning properly. Inflammation may also contribute to the disease.

One of the biggest challenges is that many patients experience severe pain even when eye examinations show very few visible signs of disease.

Because of this, neuropathic corneal pain can be difficult to diagnose and manage.

No Approved Treatment Currently Available

At present, there are no FDA-approved medicines specifically developed for neuropathic corneal pain.

Doctors often rely on off-label topical eye drops or systemic medications in an attempt to control symptoms.

However, these treatments do not work well for many patients, highlighting the significant unmet medical need in this area.

The FDA previously granted Fast Track designation to urcosimod because of the lack of approved treatment options for this condition.

How Urcosimod Works

Urcosimod is OKYO Pharma's lead investigational drug candidate.

It is a first-in-class lipid-conjugated chemerin peptide that activates the ChemR23 receptor, which is found on immune cells involved in eye inflammation as well as certain nerve cells.

The treatment is designed to work through two mechanisms at the same time.

It aims to:

• Reduce eye inflammation
• Relieve nerve-related eye pain

According to the company, preclinical research has demonstrated both anti-inflammatory and pain-relieving activity, supporting its potential as a treatment for neuropathic corneal pain.

Fast Track Designation Supports Development

The US FDA has already granted Fast Track designation to urcosimod.

This designation is intended for investigational therapies that address serious conditions with limited treatment options.

The program allows companies to work more closely with the FDA during development and may help speed up the review process if future clinical results are successful.

For OKYO Pharma, the designation reflects the urgent need for new treatment options for patients living with neuropathic corneal pain.

About OKYO Pharma

OKYO Pharma Limited is a clinical-stage biopharmaceutical company focused on developing innovative therapies for neuropathic corneal pain and other diseases affecting the front portion of the eye.

The company's lead investigational therapy, urcosimod, is currently being developed as a potential first-in-class treatment for neuropathic corneal pain, an area where no approved therapies are currently available.

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