OKYO Pharma Limited announced 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: a statistically significant and durable reduction in ocular pain. statistically significant improvement in Tear Film Break-Up Time (TFBUT) throughout the study - a clinically important endpoint.

multiple symptomatic improvements as observed by both data obtained from patient clinic visits as well as data from patient daily symptom diaries. 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. 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.

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.