OKYO Pharma Limited OKYO announced additional key findings from analyses of the clinical data set from the 240-patient Phase 2 trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (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
These results complement the statistically significant effects reported earlier on sign and symptoms endpoints, enabling definitive Phase 3 development of OK-101.
The company previously reported statistically significant improvements in total conjunctival staining (a sign endpoint) as early as Day 29 and burning/stinging and blurred vision (symptom endpoints) measured by a visual analog scale (VAS) as early as Day 15 for burning/stinging (p=0.03), and at Day 29 (p = 0.01) for blurred vision.
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 that was durable throughout the trial.
Furthermore, OK-101 improved TFBUT as early as Day 15 and lasted throughout the trial.
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) was 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 three patients in the placebo-treated group (n=79).
Price Action: OKYO shares are down 10.01% at $1.58 on the last check Friday.
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