Positive safety results reported for Nyxol in pediatric patients
Click Here to Manage Email Alerts
Nyxol demonstrated positive results in a pediatric safety trial to reverse pharmacologically induced mydriasis, according to a press release from Ocuphire Pharma.
Safety and efficacy results in the subjects aged 3 to 11 years in the MIRA-4 trial were consistent with those seen in previous studies conducted in both teenagers and adults.
“These results add to our large body of clinical data demonstrating the safety and efficacy of Nyxol for [pharmacologically induced mydriasis] and may potentially support a broader label to include children as young as age 3 to older adults,” Ocuphire founder and CEO Mina Sooch, MBA, said in the release.
The MIRA-4 trial met the primary endpoint and demonstrated favorable safety and tolerability profiles. No adverse events were observed.
At 90 minutes after receiving Nyxol, 64% of subjects had returned to baseline pupil diameter compared with 25% of subjects on placebo. At 3 hours after dosing, those values were 82% and 33%, respectively, and at 24 hours, 91% and 51%, respectively.
“We remain on track for our planned [new drug application] submission to the FDA later this year, and if approved, Ocuphire will be well positioned for a launch in the second half of 2023 for Nyxol as the only commercially available treatment option indicated for reversing pharmacological eye dilation,” Sooch said in the release.
Collapse
Read more about
Click Here to Manage Email Alerts