Viatris and Ocuphire Pharma Receive the US FDA’s Approval of Ryzumvl (Phentolamine Ophthalmic Solution) for Pharmacologically-Induced Mydriasis
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- The approval was based on the MIRA clinical program incl. P-IIb (MIRA-1), P-III (MIRA-2 & 3) studies in 553 patients aged 12-80yrs. & P-III (MIRA-4) pediatric trial evaluating Ryzumvi. Patients will receive either 2 drops of Ryzumvi or PBO in the study eye & 1 drop in the fellow eye, 1 hr. post pharmacologically-induced mydriasis
- In both trials, the percentage of patients with study eyes returning to ≤0.2 mm from baseline pupil diameter was greater at all time points measured from 60min. through 24hrs. Findings also showed that the change from maximum pupil dilation in study eyes and fellow eyes was different b/w the groups
- The product is expected to be available in the US in H1’24. The P-III trial (MIRA-4) showed that Ryzumvi rapidly reversed mydriasis
Ref: PRNewswire | Image: Viatris
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
