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OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Multiple Signs and Symptoms of Dry Eye Disease including Ocular Pain Relief in its First-in-Human Phase 2 Trial of OK-101 | ||||||||
By: GlobeNewswire - 22 Mar 2024 | Back to overview list |
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LONDON and NEW YORK, March 22, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announced today additional key findings from analyses of the clinical data set from the 240 patient Phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with DED. These new findings include:
These results complement the statistically significant effects reported earlier on sign and symptoms endpoints, enabling definitive Phase 3 development of OK-101; using FDA recognized endpoints per the Dry Eye: Developing Drugs for Treatment Guidance for Industry. The Company previously reported statistically significant improvements in total conjunctival staining (a sign endpoint), as measured by the Ora Calibra© Staining Scale as early as Day 29 (p = 0.034) and burning/stinging and blurred vision (symptom endpoints) measured by a visual analogue scale (VAS) as early as Day 15 for burning/stinging (p=0.03), and at Day 29 (p = 0.01) for blurred vision. This Phase 2 trial was conducted by our CRO partner Ora Inc. In this press release, the Company is reporting additional OK-101 data, including conjunctival staining measured at Day 85 (p=0.056) demonstrating durability in this sign endpoint. In addition, there were significant improvements in burning/stinging (p = 0.01, 0.006, 0.003 and 0.01 at Days 15, 29, 57 and 85, respectively) and in blurred vision (p = 0.09, 0.01, 0.03 and 0.06 at Days 15, 29, 57 and 85, respectively) which demonstrated sustained improvements throughout the trial. Additional data analyses also showed statistically significant improvement in ocular pain measured by VAS that was durable throughout the trial with p values = 0.03, 0.04 and 0.01 at Days 29, 57 and 85, respectively. Furthermore, OK-101 improved TFBUT as early as Day 15 and the improvement lasted throughout the trial with p values = 0.01, 0.05, 0.02, and 0.03 at Days 15, 29, 57 and 85, respectively. Notably, it has been difficult to demonstrate statistical significance for the measurement of increase in TFBUT in clinical trials of DED treatments, due mainly to patient-to-patient variability. The positive results observed in this trial carry particular significance as OK-101’s proposed MOA involves the normalization of goblet cell density as well as generating a healthier conjunctiva, a reduction of ocular pain and decreased inflammatory activity. An increase in goblet cell density should be expected to lead to an increase in mucin production, playing a key role in the physiology of the corneal tear film. Importantly, data obtained from daily symptom diaries maintained by patients during the trial, commonly referred to as patient-reported outcome data, confirmed several of the DED symptoms also measured in the clinic, exhibiting significant improvements as early as Day 1 through Day 15 for pain, burning/stinging, eye dryness and itching, with p values of 0.01, 0.06, 0.005 and 0.009, respectively. This observation of statistically significant improvements in multiple DED symptoms as measured both from clinic visits and as reported by patients at home is striking. Lastly, OK-101 was extremely well tolerated with a drop comfort score of 2.3 after 2 minutes post-instillation which is comparable to those of artificial tear results as measured by the Ora Calibra© Drop Comfort Scale1 of 0–10, with a value of 0 being most comfortable and 10 being least comfortable. Notably, OK-101 exhibited placebo-like tolerability with a very low adverse event profile and no drug-related serious adverse events. The number of treatment emergent adverse events (TEAEs) were observed to be similar to that of the placebo-treated group. And no severe drug related ocular TEAEs were seen. Possible drug-related TEAEs were observed in one patient in the OK-101 0.05% treatment group (n=81) and 3 patients in the placebo-treated group (n=79), again highlighting the favorable safety profile of OK-101. “The positive impact of OK-101, in its capacity to rapidly and durably improve tear film break up time, is particularly relevant for so many dry eye patients who have reduced blink rate associated with extensive screen time, reading and driving,” said Jay Pepose, M.D., Ph.D., Founder and Medical Director of Pepose Vision Institute and Professor of Clinical Ophthalmology at Washington University School of Medicine in St. Louis. “This improvement in tear film stability correlates well with the improvement of multiple dry-eye associated symptoms, such as blurred vision. A rapid tear film break-up time is observed in all forms of dry eye disease, including aqueous deficiency, evaporative and mixed.” “Our enthusiasm for the highly differentiated benefits of OK-101 in treating dry eye patients continues to build,” said Dr. Gary S. Jacob, CEO of OKYO. “OK-101 is the first investigational DED therapeutic, to our knowledge, to demonstrate statistically significant and durable improvements in both tear-film breakup time, and ocular pain. What is exciting to us is the totality of the data that we are seeing, including the improvement in conjunctival integrity, positive increase in tear-film breakup time, and improvements in the symptom endpoints of burning and stinging and blurry vision, all supporting the proposed MOA that we uncovered in preclinical animal models. Finally, OK-101 also appears to act quickly, displaying rapid reduction of ocular DED symptoms. These clinical benefits combined with OK-101’s exceptional tolerability profile make OK-101 a novel and promising therapeutic agent with the potential for a market leading position in DED.” The company will be hosting a Key Opinion Leader event featuring Jay Pepose, MD, PhD, and Anat Galor, MD, MSPH, who will discuss these significant findings in depth. 1 Torkildsen et al. Clinical Ophthalmology 2017:11 1883–1889 OK-101 Phase 2 Trial in DED Patients About OK-101 About OKYO About Ora, Inc. Forward-Looking Statements Enquiries:
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