Randomized, Parallel Arm, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically Induced Mydriasis in Healthy Pediatric Subjects
Latest Information Update: 03 Oct 2023
At a glance
- Drugs Phentolamine (Primary)
- Indications Mydriasis
- Focus Adverse reactions; Registrational
- Acronyms MIRA-4
- Sponsors Ocularis Pharma; Ocuphire Pharma
- 27 Sep 2023 According to an Ocuphire Pharma media release, the U.S. Food and Drug Administration (FDA) has approved RYZUMVI (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents
- 02 May 2023 According to an Ocuphire Pharma media release, results from this trial will be presented at the American Society of Cataract and refractive Surgery (ASCRS) 2023 and will be featured in the Marketplace Company Showcase at Eyecelerator ASCRS 2023 on May 4.
- 13 Feb 2023 According to an Ocuphire Pharma media release, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically-induced mydriasis (RM). The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.