Ocuphire Pharma begins patient enrolment for Nyxol phase 3 trial
Ocuphire Pharma said that it has enrolled the first subjects in the MIRA-3 phase 3 clinical trial of Nyxol Eye Drops in the reversal of pharmacologically-induced mydriasis.
According to the US-based clinical-stage ophthalmic biopharma company, with half a dozen sites are enrolling patients within days of activation and 10 more sites likely to begin screening shortly, top-line results from the mydriasis clinical trial are anticipated to be released early next year.
Mina Sooch — President and CEO of Ocuphire Pharma said: “The safety and efficacy of Nyxol for reversal of mydriasis have been demonstrated in our prior MIRA-1 Phase 2b and MIRA-2 Phase 3 clinical trials.
“Both of these trials successfully met their primary and multiple secondary endpoints with statistical significance. We know that over half of patients take 6 hours or longer, sometimes 24 hours, to return to their normal pre-dilated pupil size.
“Our prior data on Nyxol showed that 50% of patients returned to baseline by 90 minutes and 80% by 3 hours.”
A positive outcome in MIRA-3 comparable to the results achieved in MIRA-2 will position us to submit an NDA for Nyxol for reversal of mydriasis in late 2022. Successful completion of MIRA-3, as well as our planned smaller pediatric safety study, will bring the total number of patients treated with Nyxol to over 500, out of over 900 study subjects.”
Nyxol is designed as a preservative-free, ophthalmic formulation of phentolamine mesylate. Its objective is to decrease the size of the pupil by inhibiting or relaxing the iris dilator muscle.
The MIRA-3 phase 3 trial aims to enroll nearly 330 subjects of 12 years and older.
Following the screening, eligible patients are randomly grouped 2:1 to one of the treatment arms of Nyxol or placebo, respectively. The mydriasis patients will get one of three approved mydriatic agents nearly an hour before receiving study treatment drops, said Ocuphire Pharma.
The primary efficacy endpoint of the MIRA-3 phase 3 clinical trial is the percentage of the patients’ study eyes restoring to ≤ 0.2 mm from baseline photopic pupil diameter at 90 minutes.
The late stage’s secondary endpoints will be pupil diameter recorded at various time points from 30 minutes to 24 hours, accommodation, and a patient questionnaire, and new assessments of glare disability, pupillary response to light, and glare tolerability.