OKYO Pharma Reports New Phase 2 Data Demonstrating Meaningful Improvements in Patient-Reported Quality of Life Outcomes with Urcosimod in Neuropathic Corneal Pain

Rhea-AI Summary

OKYO Pharma (Nasdaq: OKYO) reported exploratory Phase 2a patient-reported quality-of-life (QoL) improvements with 0.05% urcosimod for neuropathic corneal pain (NCP). Treatment (n=6) showed greater mean improvements versus placebo (n=6) in emotional well-being, mood, and time spent thinking about eye pain.

Findings will be presented at ARVO 2026 and the company plans larger confirmatory Phase 2b/3 studies to validate these results.

Positive

• QoL improvement: Enjoying life mean change −4.5 vs 0 (placebo)
• Pain-related reduction: Time thinking about eye pain mean change −3.0 vs −1.5
• Advances to confirmatory studies: Planned larger multi-center Phase 2b/3 trial

Negative

• Very small sample: ITT population n=6 (urcosimod) vs n=6 (placebo)
• Exploratory analysis only: Secondary endpoints not yet validated in larger trials

News Market Reaction – OKYO

+1.25%

2 alerts

+1.25% News Effect

+11.2% Peak Tracked

+$1M Valuation Impact

$87M Market Cap

0.0x Rel. Volume

On the day this news was published, OKYO gained 1.25%, reflecting a mild positive market reaction. Argus tracked a peak move of +11.2% during that session. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $87M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Urcosimod dose: 0.05% Urcosimod patients: n=6 Placebo patients: n=6 +5 more

8 metrics

Urcosimod dose 0.05% Phase 2a NCP trial concentration

Urcosimod patients n=6 Intent-to-Treat population receiving urcosimod

Placebo patients n=6 Intent-to-Treat population receiving placebo

Treatment duration 12 weeks Phase 2a treatment period

Enjoying life change −4.5 vs 0 (IQR −6.00 to −0.75 vs −4.75 to 1.25) QoL score change urcosimod vs placebo (0–10 scale)

Mood change −1.5 vs −0.5 (IQR −5.25 to 0.25 vs −4.75 to 2.25) Mood score change urcosimod vs placebo (0–10 scale)

Thinking about eye pain −3.0 vs −1.5 (IQR −5.00 to 0.00 vs −4.00 to 0.00) Time spent thinking about eye pain (0–10 scale)

QoL scale range 0–10 Scale for patient-reported outcomes

Market Reality Check

Price: $1.57 Vol: Volume 180,792 is below t...

normal vol

$1.57 Last Close

Volume Volume 180,792 is below the 20-day average of 220,312 (relative volume 0.82). normal

Technical Shares at 1.60 are trading below the 200-day MA of 2.26 and well under the 52-week high of 3.349.

Peers on Argus

OKYO fell 4.76% while key biotech peers showed mixed moves: several (e.g., IRD, ...

2 Up 1 Down

OKYO fell 4.76% while key biotech peers showed mixed moves: several (e.g., IRD, ATRA, XBIT) declined, but OVID rose 3.08%, indicating stock-specific dynamics rather than a uniform sector trade.

Common Catalyst One peer, OVID, also had clinical and financing news, but broader peer action does not show a coordinated sector move tied to this OKYO trial update.

Previous Clinical trial Reports

5 past events · Latest: Jan 30 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 30	Trial data presentation	Positive	+0.5%	ASCRS 2026 acceptance of Phase 2 urcosimod efficacy and safety abstract.
Dec 11	Corneal nerve outcomes	Positive	+6.9%	Phase 2 trial data showing favorable exploratory corneal nerve structure changes.
Sep 22	Expanded trial plan	Positive	+13.6%	Announcement of 100-patient multicenter urcosimod trial after strong pain reduction data.
Jul 16	Phase 2 efficacy win	Positive	+7.6%	Positive Phase 2 results with high pain reduction rates and no serious adverse events.
Apr 30	Development acceleration	Positive	+0.0%	Plan to accelerate urcosimod development after early Phase 2 completion.

Pattern Detected

Clinical trial updates for urcosimod have generally coincided with positive share reactions, with only one flat session among recent same-tag events.

Recent Company History

Over the past year, OKYO has repeatedly highlighted urcosimod’s clinical progress. Updates on Phase 2 pain reduction, corneal nerve trends, and trial acceleration on Apr 30, 2025, Jul 16, 2025, and Sep 22, 2025 produced gains of 7.64% to 13.64%. New nerve outcome data on Dec 11, 2025 also saw a 6.93% rise. A more modest abstract-acceptance update on Jan 30, 2026 led to only a 0.49% move. Today’s QoL-focused Phase 2 data fits this ongoing urcosimod narrative.

Historical Comparison

+5.7% avg move · In the past year, OKYO released 5 urcosimod clinical trial updates averaging a 5.74% move. Today’s -...

clinical trial

+5.7%

Average Historical Move clinical trial

In the past year, OKYO released 5 urcosimod clinical trial updates averaging a 5.74% move. Today’s -4.76% reaction to new QoL Phase 2 data contrasts with that generally positive pattern.

Clinical-trial news shows steady progression from initial Phase 2 efficacy and safety signals, through corneal nerve structure data and conference acceptances, toward larger multicenter Phase 2b/3 planning for neuropathic corneal pain.

Regulatory & Risk Context

Active S-3 Shelf · $200,000,000

Shelf Active

Active S-3 Shelf Registration 2026-02-02

$200,000,000 registered capacity

An effective Form F-3 shelf filed on 2026-02-02 allows OKYO to issue up to $200,000,000 of securities over time, providing financing flexibility as it advances urcosimod but also enabling further equity or other securities offerings.

Market Pulse Summary

This announcement adds new Phase 2a data showing urcosimod improved multiple quality-of-life measure...

Analysis

This announcement adds new Phase 2a data showing urcosimod improved multiple quality-of-life measures for neuropathic corneal pain patients on a 0–10 scale after 12 weeks. It builds on prior pain and nerve-structure signals and fits a pattern of steadily expanding clinical evidence. Investors may watch for the planned larger Phase 2b/3 trial, execution under the existing $200,000,000 shelf, and how future readouts compare with these exploratory results.

Key Terms

phase 2a, visual analogue scale (vas), neuropathic corneal pain (ncp), double-masked, +3 more

7 terms

phase 2a medical

"exploratory analysis of patient-reported outcomes in its recently completed Phase 2a trial"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

visual analogue scale (vas) medical

"including reductions in pain as measured by the VAS, improvements in"

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.

neuropathic corneal pain (ncp) medical

"for the treatment of neuropathic corneal pain (NCP) and for inflammatory"

Neuropathic corneal pain is chronic eye pain caused by damage or abnormal signaling in the nerves of the cornea, producing burning, stinging, or painful sensitivity often without visible surface injury. It matters to investors because it creates demand for specialized diagnostics and long‑term treatments distinct from standard eye drops—think of it like phantom limb pain for the eye—making it a potential market for new therapies and medical devices.

double-masked medical

"In this Phase 2, randomized, double-masked, placebo-controlled study,"

Double-masked describes a clinical study setup where neither the people receiving treatments nor the researchers who administer or assess them know who gets the active therapy versus a placebo or comparison. This reduces conscious or unconscious bias and makes results more reliable for regulators and doctors. For investors, double-masked trials carry more credibility—like a taste test where neither the tasters nor the servers know which sample is which—so positive outcomes and approvals are taken more seriously.

placebo-controlled medical

"randomized, double-masked, placebo-controlled study, patients with NCP"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

intent-to-treat (itt) medical

"or placebo (n=6) in the Intent-to-Treat (ITT) population."

Intent-to-treat (ITT) is a rule for analyzing clinical trial results that counts every participant in the group they were originally assigned to, regardless of whether they completed the treatment or followed the protocol. For investors, ITT matters because it gives a conservative, real-world estimate of how well a treatment works and helps reveal whether reported benefits are robust or likely to shrink when the product reaches the broader market — like scoring a team’s performance by including every player who showed up, not just those who played the whole game.

interquartile range medical

"(IQR = Interquartile Range) These secondary findings build on the primary"

A statistic that measures the spread of the middle 50% of a data set by subtracting the value at the 25th percentile from the value at the 75th percentile. Think of it as the width of the crowd’s center — it shows how tightly grouped the typical observations are while ignoring extreme highs or lows. For investors, it helps gauge typical variability in prices, returns, or forecasts and compare consistency across assets or periods.

AI-generated analysis. Not financial advice.

LONDON and NEW YORK, March 18, 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 announced new positive findings from an exploratory analysis of patient-reported outcomes in its recently completed Phase 2a trial of urcosimod (0.05%) for the treatment of NCP. This new quality-of-life (QoL) data will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting. The presentation, titled: “First-in-Human Study of Urcosimod to Treat Neuropathic Corneal Pain (NCP) Shows Clinically Meaningful Pain Reduction and Quality-of-Life Improvement in NCP Patients” will detail the Phase 2a clinical trial results, including reductions in pain as measured by the VAS, improvements in patient-reported QoL measures, as well as signals suggesting potential restoration of corneal nerve structure in NCP patients. This event represents a key opportunity to share these new findings with global eye and vision researchers, clinicians, and industry leaders.

In this Phase 2, randomized, double-masked, placebo-controlled study, patients with NCP received either 0.05% urcosimod (n=6) or placebo (n=6) in the Intent-to-Treat (ITT) population. After 12 weeks of treatment, patients receiving urcosimod demonstrated greater improvements across key aspects of emotional well-being and quality of life compared to placebo. These measures were assessed on a 0–10 scale.

Notable improvements included:

• Enjoying life/relationships with other people: mean change from baseline of −4.5 (IQR −6.00 to −0.75) for urcosimod vs. 0 (IQR −4.75 to 1.25) for placebo.
• Mood: mean change of −1.5 (IQR −5.25 to 0.25) for urcosimod vs. −0.5 (IQR −4.75 to 2.25) for placebo.
• Time spent thinking about eye pain: mean change of −3.0 (IQR −5.00 to 0.00) for urcosimod vs. −1.5 (IQR −4.00 to 0.00) for placebo.
  

(IQR = Interquartile Range)

These secondary findings build on the primary efficacy signals from the trial, where urcosimod previously demonstrated meaningful reductions in pain as measured by the Visual Analogue Scale (VAS). The exploratory patient-reported outcomes data suggest that urcosimod may provide broader therapeutic benefits, contributing to enhanced emotional well-being and overall day-to-day life satisfaction for patients suffering from this debilitating condition.

NCP is a severe, chronic ocular pain disorder with no FDA-approved treatments available, representing a major unmet medical need. These results highlight urcosimod's potential holistic profile beyond pain reduction alone.

OKYO Pharma remains committed to addressing this significant unmet need and advancing urcosimod through further development. The Company plans confirmatory studies to validate these encouraging exploratory results as part of its ongoing program, including a planned larger multi-center Phase 2b/3 trial.

“We are pleased to see these patient-reported quality-of-life benefits emerging alongside the primary pain reduction signals from urcosimod,” said Flavio Mantelli, MD, PhD, Chief Medical Officer at OKYO Pharma. “Like pain, QoL is a clinically meaningful endpoint, and this exploratory analysis reinforces the holistic therapeutic profile of urcosimod and strengthens our confidence as we advance toward larger confirmatory trials to fully characterize its potential in addressing the profound burden of NCP.”

“We are encouraged by the consistent improvements observed across key patient-reported outcomes, including time spent thinking about eye pain and functional measures such as mood and enjoying activities, compared with placebo,” said Raj Patil, Ph.D., Chief Scientific Officer at OKYO Pharma. “These findings support the potential of urcosimod therapy to meaningfully impact patients living with neuropathic corneal pain, a debilitating condition without FDA-approved therapy.”

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 2a trial involving 18 neuropathic corneal pain subjects. Urcosimod has shown significant pain reduction in an earlier 240 subject Phase 2, multi-center, double-masked, placebo-controlled trial in DED, which supports the development rationale in NCP.

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 subjects with NCP and plans to initiate a ~150 subject 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 forward-looking statements, except as may be required by law.

For further inquiries:

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

FAQ

What Phase 2a QoL results did OKYO (OKYO) report on March 18, 2026 for urcosimod?

OKYO reported exploratory Phase 2a QoL improvements, including enjoyment of life and mood gains versus placebo. According to the company, urcosimod (0.05%) showed greater mean improvements across emotional well-being and time spent thinking about eye pain in the ITT population.

How large was the Phase 2a trial of urcosimod reported by OKYO (OKYO) at ARVO 2026?

The Phase 2a trial enrolled a small ITT population of 12 patients, with n=6 receiving urcosimod and n=6 placebo. According to the company, results are exploratory and will be evaluated further in larger confirmatory studies.

What specific patient-reported measures improved with urcosimod in OKYO's Phase 2a study?

Improvements included enjoying life/relationships, mood, and time spent thinking about eye pain versus placebo. According to the company, enjoying life mean change was −4.5 for urcosimod compared with 0 for placebo on a 0–10 scale.

Will OKYO (OKYO) run more trials after the Phase 2a urcosimod results?

Yes. OKYO plans a larger multi-center Phase 2b/3 trial to confirm these exploratory findings and further characterize efficacy and safety. According to the company, these studies aim to validate QoL and pain reduction signals from Phase 2a.

Were the Phase 2a urcosimod results statistically conclusive in OKYO's announcement?

No definitive claim of statistical conclusiveness was made; the results were described as exploratory and suggestive of clinical benefit. According to the company, the findings support further confirmatory trials rather than final efficacy conclusions.

When and where will OKYO (OKYO) present the urcosimod Phase 2a QoL data?

OKYO will present the findings at the ARVO 2026 Annual Meeting. According to the company, the presentation details clinically meaningful pain reduction and QoL improvements observed in the Phase 2a study.