The submission is supported by positive phase 3 data, which shows quick reversal of dilation and favorable safety and tolerability.
On December 6, Ocuphire Pharma announced that they have submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for phentolamine ophthalmic solution 0.75% (Nyxol) for the reversal of mydriasis (RM). The reversal is produced by an adrenergic agonist (phenylephrine), parasympatholytic agents (tropicamide), or a combination of the two.
The comprehensive MIRA clinical program investigated phentolamine ophthalmic solution 0.75% for RM. MIRA-2 and MIRA-3 phase 3 pivotal trials met both primary and key secondary endpoints, and the data are included in the NDA submission due to the statistically significant superiority of phentolamine compared to placebo. Across the clinical program, phentolamine showed favorable safety and tolerability profiles.
“The NDA submission for Nyxol is an important step toward our goal of providing a reversal option for the millions of standard eye exams and procedures that involve dilation,” Mina Sooch, MBA, Founder and CEO of Ocuphire Pharma, said in a press release. “Achieving this milestone is a testament to the commitment of the clinical trial investigators, their staff and trial participants as well as the Ocuphire team and its network of development partners who have worked diligently to advance Nyxol towards a potential approval in RM.”
Phentolamine ophthalmic solution 0.75% rapidly returns dilated eyes to baseline pupil diameter as soon as 60 and 90 minutes from dilation.
The MIRA clinical program included the MIRA-1 phase 2b trial, MIRA-2 and MIRA-3 phase 3 pivotal trials, and the MIRA-4 phase 3 pediatric trial. The program involved over 600 subjects collectively. The MIRA-4 pediatric trial data support label expansion to include patients age 3 and older.
Ocuphire is a clinical-stage ophthalmic biopharmaceutical company that is dedicated to the development and commercialization of therapies and treatments for refractive and retinal eye disorders. The company recently entered a global license agreement with FamyGen Life Sciences for the development of phentolamine ophthalmic solution 0.75% across 3 indications. Ocuphire received a $35 million upfront payment per the agreement.