OKYO Pharma Announces Successful Type C Meeting with the FDA

Rhea-AI Summary

OKYO Pharma (Nasdaq: OKYO) announced a successful Type C meeting with the FDA on Jan 28, 2026, confirming the proposed Phase 2b/3 design for urcosimod to treat neuropathic corneal pain. The FDA agreed the primary endpoint (VAS pain reduction at Week 12; ≥2-point improvement meaningful), endorsed sample size and powering, supported OPAS as supportive QoL evidence, and aligned on CMC and key clinical elements. OKYO expects to initiate a 120-patient Phase 2b/3 multiple-dose study in the first half of 2026.

Positive

• FDA confirmed VAS Week 12 primary endpoint with ≥2-point meaningful improvement
• FDA endorsed study design, sample size, and powering for Phase 2b/3
• OPAS accepted as supportive quality-of-life evidence
• CMC alignment with no material issues, de-risking pivotal trial pathway
• Planned 120-patient Phase 2b/3 study expected to start H1 2026

Negative

• Regulatory outcome contingent on robust clinical results for potential registration

News Market Reaction – OKYO

+2.82% 3.8x vol

13 alerts

+2.82% Session close to close

+9.1% Peak Tracked

-16.5% Trough Tracked

$82.37M Market Cap

3.8x Rel. Volume

In the Jan 28 session, OKYO gained 2.82%, reflecting a moderate positive market reaction. Argus tracked a peak move of +9.1% during that session. Argus tracked a trough of -16.5% from its starting point during tracking. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility. Trading volume was very high at 3.8x the daily average, suggesting strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement details FDA alignment on the Phase 2b/3 design for urcosimod in neuropathic cornea...

Analysis

This announcement details FDA alignment on the Phase 2b/3 design for urcosimod in neuropathic corneal pain, including a clinically meaningful ≥2-point VAS improvement at Week 12 and a planned 120-patient study. It builds on prior fast track status and earlier Phase 2 data. Investors may watch trial initiation timing, endpoint execution, and subsequent FDA meetings as critical indicators of program momentum and regulatory readiness.

Key Figures

VAS improvement threshold: ≥2-point improvement Primary endpoint timing: Week 12 Planned study size: 120 patients

3 metrics

VAS improvement threshold ≥2-point improvement Clinically meaningful change on Visual Analogue Scale at Week 12

Primary endpoint timing Week 12 Assessment timepoint for VAS pain reduction primary endpoint

Planned study size 120 patients Planned Phase 2b/3 multiple-dose study of urcosimod in NCP

Historical Context

5 past events · Latest: Jan 23 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jan 23	Compassionate use approval	Positive	-6.3%	FDA authorized single-patient expanded access IND for urcosimod in severe NCP.
Jan 05	Leadership change	Positive	+7.6%	Appointment of ophthalmology-focused CEO to advance urcosimod development strategy.
Dec 19	Nasdaq bell ringing	Positive	+8.6%	Nasdaq ceremony highlighting progress and positive Phase 2 results for urcosimod.
Dec 15	Insider share purchase	Positive	-8.3%	Chairman increased holdings via open-market share purchase on Nasdaq.
Dec 11	Clinical data update	Positive	+6.9%	Phase 2 trial showed favorable corneal nerve structure trends supporting further study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent OKYO headlines have mostly been positive, but price reactions have been mixed, with both rallies and selloffs on favorable clinical and regulatory news.

Recent Company History

Over the last few months, OKYO has reported multiple milestones centered on urcosimod. On Dec 11, 2025, positive Phase 2 corneal nerve data coincided with a 6.93% gain. Subsequent insider share purchases on Dec 15, 2025 saw a -8.25% move. A CEO transition and strategic focus on urcosimod on Jan 5, 2026 led to a 7.62% rise. Compassionate use authorization on Jan 23, 2026 then saw a -6.33% reaction, underscoring inconsistent trading responses to positive developments.

Key Terms

visual analogue scale (vas), ocular pain assessment survey (opas), statistical analysis plan (sap), chemistry, manufacturing and controls (cmc), +2 more

6 terms

visual analogue scale (vas) medical

"primary endpoint of the Visual Analogue Scale (VAS) pain reduction at Week 12"

A visual analogue scale (VAS) is a simple patient-reported tool where someone marks their symptom severity along a straight line between two labeled endpoints (for example, “no pain” to “worst pain imaginable”). Investors pay attention because VAS scores are often used in clinical trials and patient studies to measure whether a treatment meaningfully changes symptoms; like a thermometer for feelings, the results can affect trial success, regulatory decisions, and market expectations.

ocular pain assessment survey (opas) medical

"agreed that the Ocular Pain Assessment Survey (OPAS) is appropriate as supportive"

A patient questionnaire that measures the presence, severity and daily impact of eye pain as reported directly by patients. Like a thermometer for discomfort, it converts personal sensations into consistent scores that researchers and regulators can compare across studies; investors watch these scores because they help demonstrate whether an eye drug or device actually relieves symptoms, influence trial success, label claims and market potential.

statistical analysis plan (sap) technical

"noting that if the statistical analysis plan (SAP) is finalized prior to unmasking"

A statistical analysis plan (SAP) is a detailed blueprint that spells out, before results are seen, exactly how data from a study or trial will be checked, measured and compared. Investors care because a clear SAP reduces the chance of surprise or biased interpretation, making study results more reliable for judging a product’s safety, effectiveness or market potential—like reading a recipe before judging the cake it produces.

chemistry, manufacturing and controls (cmc) regulatory

"FDA alignment on the Chemistry, Manufacturing and Controls (CMC) strategy and key clinical elements"

Chemistry, manufacturing and controls (CMC) is the set of scientific and operational steps that show how a drug or biologic is made, what goes into it, and how its quality is consistently checked—think of it as the recipe, the factory process, and the quality checklist for a medicine. Investors care because strong CMC reduces risks around regulatory approval, production delays, batch failures and unexpected costs, directly affecting a product’s ability to reach market and generate revenue.

investigational new drug (ind) regulatory

"urcosimod was granted the first IND to treat patients with NCP"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

fast track designation regulatory

"was awarded fast track designation by the Food and Drug Administration (FDA)"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FDA confirms Phase 2b/3 clinical design, including primary endpoint, sample size and development approach

LONDON and NEW YORK, Jan. 28, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announces that it held a successful Type C meeting with the Food & Drug Administration (FDA) regarding the Phase 2b/3 human clinical trial of urcosimod for the treatment of neuropathic corneal pain (NCP).

Key highlights from the Type C FDA meeting include:

• FDA confirms the approach that the proposed primary endpoint of the Visual Analogue Scale (VAS) pain reduction at Week 12 is clinically meaningful, including explicit acknowledgment that a ≥2-point improvement on the VAS scale represents a meaningful treatment effect
• The Agency provided statistical guidance to enhance robustness, noting that if the statistical analysis plan (SAP) is finalized prior to unmasking and results are strong, the data could provide substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting
• FDA endorsed the proposed study design, sample size, and powering assumptions, and agreed that the Ocular Pain Assessment Survey (OPAS) is appropriate as supportive quality-of-life evidence
• FDA alignment on the Chemistry, Manufacturing and Controls (CMC) strategy and key clinical elements, with no material issues raised, derisking the pathway to a pivotal trial and supports potential registration if study results are robust

“We were very pleased to achieve meaningful progress with the FDA toward alignment on urcosimod’s clinical development program,” said Raj Patil, Ph.D., Chief Scientific Officer at OKYO Pharma. “This alignment represents an important step forward and underscores the potential to address a significant unmet medical need in patients with neuropathic corneal pain.”

“I want to thank the entire OKYO team for their focus, rigor, and collaboration that led to this successful Type C meeting with the FDA,” said Robert Dempsey, CEO of OKYO Pharma. “This positive outcome reflects years of disciplined scientific and clinical execution; moreover, the FDA’s alignment on our Phase 2b/3 strategy meaningfully de-risks the program. The results of this meeting also represent a meaningful value-inflection point for urcosimod and, most importantly, a step forward for patients suffering from neuropathic corneal pain, where the unmet need remains profound.”

As previously communicated, urcosimod was granted the first IND to treat patients with NCP and was awarded fast track designation by the Food and Drug Administration (FDA). The company expects to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

About Neuropathic Corneal Pain (NCP)

Neuropathic corneal pain (NCP) is a chronic, often debilitating condition characterized by severe pain and sensitivity of the eyes, and in some cases the face or head. It is thought to result from damage or dysfunction of corneal sensory nerves, often in combination with inflammatory processes, and may occur in patients with a range of underlying ophthalmic conditions. There are currently no FDA-approved therapies specifically for NCP, resulting in patients being treated with limited or no success using various topical and systemic medications in an off-label manner.

About Urcosimod (formerly called OK-101)

Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2 trial involving 18 neuropathic corneal pain patients. Urcosimod showed clear statistical significance in multiple endpoints in an earlier 240-patient Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease.

About OKYO Pharma

OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases, with ordinary shares listed for trading on the Nasdaq Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in patients with NCP and plans to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

For further information, please visit www.okyopharma.com.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 20-F, for the fiscal year ended March 31, 2025. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these.

For further inquiries:

OKYO Pharma Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
Email: info@okyopharma.com

FAQ

What did OKYO (OKYO) announce about its FDA Type C meeting on January 28, 2026?

OKYO said the FDA endorsed the proposed Phase 2b/3 design and primary endpoint for urcosimod. According to the company, the FDA agreed the VAS Week 12 endpoint (≥2-point improvement) and supported sample size, powering, OPAS use, and CMC approach.

What is the primary endpoint the FDA accepted for OKYO's urcosimod Phase 2b/3 trial (OKYO)?

The FDA accepted VAS pain reduction at Week 12 as the primary endpoint, with a ≥2-point improvement deemed clinically meaningful. According to the company, this provides a clear, patient-focused efficacy measure for the proposed pivotal study.

When does OKYO plan to start the 120-patient Phase 2b/3 study for urcosimod (OKYO)?

OKYO expects to initiate the 120-patient multiple-dose Phase 2b/3 study in the first half of 2026. According to the company, this timeline follows FDA alignment on design, powering, OPAS support, and CMC strategy from the Type C meeting.

How did the FDA view supportive measures like OPAS and CMC for OKYO's urcosimod program (OKYO)?

The FDA endorsed OPAS as appropriate supportive quality-of-life evidence and aligned on CMC strategy with no material issues. According to the company, these points help de-risk the pathway toward a potential pivotal trial and registration.

Does the FDA's Type C alignment guarantee approval for urcosimod from OKYO (OKYO)?

No—FDA alignment does not guarantee approval; it conditions potential registration on strong trial results. According to the company, substantial evidence of effectiveness would still be required and depends on robust Phase 2b/3 outcomes.