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OKYO Pharma Limited’s SEC filings document foreign-private-issuer reports on Form 6-K for a clinical-stage biopharmaceutical company with ordinary shares listed on Nasdaq. The disclosures cover urcosimod clinical and regulatory updates for neuropathic corneal pain, scientific-meeting materials, and descriptions of the company’s focus on inflammatory eye diseases and other ocular disorders.
The filing record also includes capital-structure and financing disclosures tied to Form F-3 registration statements, ordinary-share offerings, underwriter option exercises, and insider share purchases. These records present formal updates on the company’s securities, ownership activity, incorporated exhibits, and material announcements furnished under Exchange Act Rule 13a-16.
OKYO Pharma reported interim results for the six months ended 30 September 2025, highlighting progress on its lead drug urcosimod for neuropathic corneal pain (NCP). The company secured FDA Fast Track Designation for urcosimod in NCP and reported strong Phase 2 proof-of-concept data in 18 patients, with 75% of per-protocol patients achieving more than 80% pain reduction on the Visual Analogue Scale after 12 weeks.
OKYO also strengthened its leadership by appointing Robert J. Dempsey as Chief Executive Officer and transitioning former CEO Gary S. Jacob to Chief Development Officer. Following a successful FDA Type C meeting, the agency confirmed alignment on the proposed 150-patient Phase 2b/3 trial design, including a primary endpoint of VAS pain reduction at Week 12.
Financially, total assets were $4.6 million as of 31 March 2025, with cash on hand of $4.2 million, up from $1.6 million. The company recorded a total comprehensive loss of $3.0 million, slightly improved from a $3.2 million loss for the comparable prior-year period.
OKYO Pharma Limited filed a Form 6-K to share that an abstract on its lead drug candidate urcosimod (formerly OK-101) has been accepted for presentation at the 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The paper will present proof-of-concept Phase 2 efficacy and safety results in neuropathic corneal pain during the Ocular Surface Disease II session on April 11, 2026, in Washington, DC.
The company highlights positive efficacy signals from the completed Phase 2 trial, including meaningful pain reduction and encouraging corneal nerve health trends, and describes urcosimod as a potential first-in-class therapy for neuropathic corneal pain, which currently has no FDA-approved treatments. OKYO reiterates prior FDA fast track designation and the first IND for NCP, and states it plans to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod in the first half of 2026.
OKYO Pharma reports that the FDA held a successful Type C meeting with the company on the Phase 2b/3 clinical trial of urcosimod for neuropathic corneal pain (NCP). The FDA confirmed the planned trial design, including the primary endpoint, sample size, and overall development approach.
Urcosimod already has the first IND for NCP and fast track designation, and OKYO recently completed a positive Phase 2 NCP trial and an earlier 240-patient Phase 2 dry eye disease study with statistically significant results. The company plans to start a 120-patient Phase 2b/3 multiple-dose study for NCP in the first half of the year, aiming to address a condition with no FDA-approved treatments.
OKYO Pharma Limited reports that the U.S. Food and Drug Administration has authorized a single-patient expanded access (compassionate use) IND for its drug candidate urcosimod (0.05%) to treat a patient with severe neuropathic corneal pain who has limited options and no FDA-approved treatments available. The IND was submitted by Pedram Hamrah, MD, at the University of South Florida, and urcosimod is being provided by OKYO under this authorization.
The company notes that urcosimod previously received the first IND to treat neuropathic corneal pain and was granted FDA fast track designation. OKYO recently reported positive pain-reduction data in an 18-patient Phase 2 trial in neuropathic corneal pain and earlier statistically significant results in a 240-patient Phase 2 trial in dry eye disease. It plans to start a 120-patient Phase 2b/3 multiple-dose study of urcosimod for neuropathic corneal pain this year.
OKYO Pharma LTD disclosed that Panetta Partners Limited, an entity in which Executive Chairman Gabriele Cerrone has a beneficial interest, acquired 24,551 of the company’s ordinary shares on Nasdaq on December 15, 2025.
This purchase brings Cerrone’s total holding to 10,516,297 shares of OKYO Pharma. The company has furnished a detailed news announcement about the transaction as Exhibit 99.1 to this report.
OKYO Pharma (OKYO) reported that Panetta Partners Limited, an entity in which Executive Chairman Gabriele Cerrone has a beneficial interest, purchased 82,018 of the company’s ordinary shares on NASDAQ on November 21, 2025.
This additional purchase increases Cerrone’s total beneficial holding to 10,464,695 shares. The disclosure is informational in nature and does not change the company’s capital structure or operations, but it highlights further share accumulation by a key insider.
OKYO Pharma LTD reported that its Chief Executive Officer, Gary S. Jacob, Ph.D., will present at the Ophthalmology Innovation Summit (OIS) XV. His presentation is scheduled for November 22, 2025, from 8:30–9:30 AM PT in the “Anterior Innovation Showcase” session. OIS XV, held November 21–22, 2025, at the San Diego Marriott Marquis & Marina, is described as a premier annual event that brings together innovators, investors, executives, and clinicians in eye care. The summit focuses on anterior and posterior segment advances through panel discussions, company showcases, and partnering meetings, highlighting OKYO Pharma’s participation in a global forum dedicated to treatments for vision-threatening conditions.
OKYO Pharma (OKYO) filed a Form 6-K announcing that Chief Executive Officer Gary S. Jacob, Ph.D., will present at the 33rd Annual BIO-Europe partnering conference in Vienna, Austria.
The related news announcement is furnished as Exhibit 99.1. The company states this exhibit is furnished and not deemed filed under Section 18 of the Exchange Act, nor incorporated by reference except as expressly set forth.
OKYO Pharma reported that Panetta Partners Limited, an entity in which Executive Chairman Gabriele Cerrone has a beneficial interest, acquired 210,000 of the company’s ordinary shares on NASDAQ. Following this purchase, his total holding is 10,382,677 shares. The news announcement was furnished as Exhibit 99.1 and is not deemed filed under Section 18 of the Exchange Act.
OKYO Pharma LTD has filed a Form 6-K to furnish a news announcement about the regulatory registration pathway and a planned 100-patient multi-center clinical trial of Urcosimod in neuropathic corneal pain. The company states that the announcement, dated September 22, 2025, is included as Exhibit 99.1 to the report. The furnished information is not deemed filed under the Securities Exchange Act and is not automatically incorporated into other securities law filings unless specifically referenced.