urcosimod (OK-101) / OKYO Pharma - LARVOL DELTA

The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain (clinicaltrials.gov) - P2 | N=18 | Terminated | Sponsor: Okyo Pharma Ltd | Prior Phase 2 data (240 patients) showed favorable safety and placebo-like tolerability. Closure was not due to safety concerns.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Neuralgia • Pain

FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain (GlobeNewswire) - "OKYO Pharma Limited...announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP)."

Fast track • Neuralgia • Ophthalmology • Pain

OKYO Pharma Announces Plans to Accelerate the Clinical Development of Urcosimod to Treat Neuropathic Corneal Pain (GlobeNewswire) - "OKYO Pharma Limited...announces plans to accelerate the clinical development of urcosimod to treat NCP through the analysis of its data following the early closure of its Phase 2 trial....The Phase 2 trial of urcosimod to treat NCP was being conducted at a single trial site at Tufts Medical Center in Boston, MA. The decision to close the trial now, with 17 patients having presently completed the study, is due to OKYO’s strong desire to access the currently masked data and use it to plan its expanded development program....OKYO Pharma plans for a meeting with FDA following evaluation of clinical data."

P2a data • Trial status • Neuralgia • Ophthalmology • Pain

OKYO Pharma Announces Positive Data in Long-Term Stability of Urcosimod (GlobeNewswire) - P2a | N=48 | NCT06637527 | Sponsor: Okyo Pharma Ltd | "OKYO Pharma Limited...is pleased to announce that the Company has successfully established that urcosimod (formerly known as OK-101) has been shown to be stable for over two and a half years in single-use ampoules used for administration of the drug to patients....Recently completed GMP stability assay testing of single-use ampoules containing urcosimod in ophthalmic solution, stored under refrigerated conditions, showed impressive stability (0.05% urcosimod – 94.8% and 0.1% urcosimod – 97.4%) after over two and a half years."

P2a data • Neuralgia • Ophthalmology • Pain

OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain (GlobeNewswire) - "OKYO Pharma Limited...is pleased to announce the filing of its application for Fast Track designation with the U.S. Food and Drug Administration (FDA) for urcosimod (formerly known as OK-101) for the treatment of neuropathic corneal pain, which is a debilitating condition affecting many tens of thousands worldwide, and is characterized by chronic, severe eye discomfort for which there is no FDA-approved, effective treatment."

Fast track • Neuralgia • Ophthalmology • Pain

OKYO Pharma Announces OK-101 Officially Assigned USAN : Urcosimod (GlobeNewswire) - "OKYO Pharma Limited...is pleased to announce that its lead asset, OK-101, has been officially assigned the United States Adopted Name (USAN) 'urcosimod'....The USAN designation reflects Okyo Pharma’s commitment to developing new therapies for unmet medical needs in ophthalmology."

Commercial • Ophthalmology • Pain

OKYO Pharma to Complete Enrollment of Neuropathic Corneal Pain Trial by End of Second Quarter (GlobeNewswire) - "The Company anticipates completing enrollment of the 48-patient trial by the end of 2Q 2025 and releasing top-line data on the Phase 2a trial in 4Q 2025. Results from this trial are anticipated to be a major binary event for the Company...OKYO is planning to engage with the FDA on the next clinical plans for OK-101 to treat DED."

Enrollment status • FDA event • P2a data • Dry Eye Disease • Ophthalmology • Pain

OKYO Pharma Receives $1.4 Million in Non-Dilutive Funding (GlobeNewswire) - "OKYO Pharma Limited...is pleased to announce that it has received $1.4 million in non-dilutive funding. This significant financial funding strengthens the Company’s ability to advance its innovative pipeline without diluting shareholder value. The funding will be strategically allocated to support ongoing research and development initiatives, with particular emphasis on fueling progress with OKYO’s lead program, OK-101 focused on treating NCP, a major unmet medical need."

Financing • Ophthalmology

OKYO Pharma to Present at International Tear Film and Ocular Surface Society Conference (GlobeNewswire) - "OKYO Pharma Limited...is pleased to announce that it will be presenting at the 10th International Tear Film & Ocular Surface Society Conference in Venice, Italy during October 30 - November 2, 2024. The OKYO management team will be participating in one-on-one meetings to discuss the dry eye disease trial results, and also the recent opening of our Phase 2 trial of OK-101 to treat patients with Neuropathic Corneal Pain at Tufts Medical Center, Boston, Massachusetts, USA."

P2 data • CNS Disorders • Pain

The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Okyo Pharma Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Neuralgia • Pain

The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects with Neuropathic Corneal Pain (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Okyo Pharma Ltd

New P2 trial • Neuralgia • Pain

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1

OKYO Pharma Granted U.S. Patent Covering OK-101’s Potential for Treating Symptoms of Dry Eye Disease (GlobeNewswire) - "OKYO Pharma Limited...announced today the grant of a key U.S. Patent No. 12,053,501 which issued on August 6th entitled: 'Methods for Treating Symptoms of Dry Eye Disease'. The present disclosure covers issued claims on OK-101’s use to treat irritated, burning eyes and blurred vision in patients suffering from DED, strengthening the Company’s intellectual property position in this field."

Patent • Dry Eye Disease • Ophthalmology

OKYO Pharma Announces Promising Categorical Data from OK-101 Phase 2 Trial in Dry Eye Disease (GlobeNewswire) - "OKYO Pharma Limited...announced promising new categorical data analyses from the recent OK-101 Phase 2 trial in DED patients. These analyses have identified conjunctival staining and ocular pain as the highest potential 'sign' and 'symptom' co-primary endpoints to be explored in the next DED trial of OK-101."

P2 data • Dry Eye Disease • Ophthalmology

OKYO Pharma Receives FDA Approval of IND for OK-101 in Neuropathic Corneal Pain (GlobeNewswire) - "OKYO Pharma Limited...announced today that the U.S. Food and Drug Administration (FDA) has cleared OK-101 as its first Investigational New Drug (IND) application for the treatment of NCP....Based on positive feedback from FDA, the Phase 2 study is now designed as a double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in NCP patients....These protocol changes will enable a statistically valid demonstration of a true drug effect of OK-101 on NCP symptoms. OKYO Pharma is scheduling this trial to begin in Q2 2024."

IND • P2 data • CNS Disorders • Pain

The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease (clinicaltrials.gov) - P2 | N=240 | Completed | Sponsor: Okyo Pharma Ltd | Active, not recruiting ➔ Completed | Trial completion date: Apr 2024 ➔ Dec 2023

Trial completion • Trial completion date • Dry Eye Disease • Ophthalmology

OKYO Pharma Announces Filing of an Investigational New Drug (IND) Application for OK-101 to Treat Neuropathic Corneal Pain ('NCP') (GlobeNewswire) - "OKYO Pharma Limited...today announced that it filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the development of OK-101 to treat Neuropathic Corneal Pain (NCP). Study enrollment is planned to commence during Q1 2024 following IND allowance by the FDA....'We are excited about OK-101’s dual combination of anti-inflammatory ocular activity and NCP reducing activity and are eager to evaluate this drug to treat NCP while awaiting the top-line data for OK-101 from the ongoing Phase 2 DED trial which is planned for released in December 2023,'..."

IND • New trial • P2 data • Dry Eye Disease • Ophthalmology • Pain

The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease (clinicaltrials.gov) - P2 | N=240 | Active, not recruiting | Sponsor: Okyo Pharma Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

OKYO Pharma Announces Randomized Segment Now Underway in Phase 2 Clinical Trial of Topical Ocular OK-101 for Dry Eye Disease (GlobeNewswire) - "Top-line data from trial anticipated in Q4, 2023....OKYO Pharma Limited...is pleased to announce that patients are now being dosed in the randomized portion of the phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat DED, following the two-week placebo run-in period intended to minimize the placebo effect."

P2 data • Trial status • Dry Eye Disease • Ophthalmology

The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Okyo Pharma Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

OK-101, a Novel Chemerin Receptor Agonist, Decreased Clinical Signs and Symptoms and Improved Immune Tolerance in Dry Eye Mouse Model (ASCRS-ASOA 2023) - "Purpose Chemerin receptor (ChemR23 or CMKLR1), a member of the GPCR family, is expressed on select immune and epithelial/endothelial cells and modulates inflammation.The Purpose of this study was to evaluate the ability of OK-101, an agonist of Chemerin receptor, to decrease inflammatory responses in a mouse model of dry eye disease (DED).MethodsFemale C57Bl/6J mice were administered with subcutaneous injections of scopolamine and housed in chambers with low humidity and constant airflow creating desiccating stress (DS) to induce acute DED.One group was treated with OK-101 (10 l/eye of 0.04% peptide in PBS) and the second with the vehicle alone (both eyes) every 8 hours (3 times per day) throughout the course of the study.Corneal fluorescein staining (CFS) was evaluated at day 10.Activated antigen-presenting cells (MHC-II+) and T regulatory cells (Tregs) were determined in the draining lymph nodes using flow cytometry.Pain was objectively evaluated by measuring the..."

Preclinical • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology • Pain • PTPRC

OK-101, a Novel Chemerin Receptor Agonist, Improves Neuropathic Corneal Pain in Ciliary Nerve Ligation Mouse Model (ASCRS-ASOA 2023) - "Purpose Chemerin receptor (ChemR23), a member of the GPCR family expressed on select immune, epithelial, dorsal root ganglion cells and spinal cord modulates nociception.The Purpose of this study was to evaluate the ability of OK-101, an agonist of Chemerin receptor, in improving neuropathic corneal pain (NCP) in ciliary nerve ligation mouse model.MethodsNCP was induced by ligation of the ciliary nerve and confirmed by stimulation with 5M hyperosmolar saline (HS) and eye wiping response (counts/30 sec) on day 3.The integrity of the corneal epithelium was confirmed by corneal fluorescein staining (CFS).OK-101 was applied topically either 6 or 3 times/day.Balanced salt solution (BSS) served as vehicle.Gabapentin (100mg/kg i.p.) given on days 4, 7, 10 and 14-days post-surgery served as positive control.Treatment duration was for 11 days, and efficacy was measured by 5M HS and eye wiping.Safety measures included blink reflex due to mechanical stimulation by Cochet-Bonnet..."

Preclinical • Immunology • Pain

The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Okyo Pharma Ltd

New P2 trial • Dry Eye Disease • Ophthalmology