RYZUMVI (phentolamine mesylate)

Phentolamine systemic exposure was evaluated in a Phase 3 trial (MIRA-3) following topical ocular administration of a total of 3 drops, each of 0.03 mL, of phentolamine ophthalmic solution 0.75%. The peak concentration levels are achieved between 15 minutes and 1 hour after dosing with the median value of 0.45 ng/mL.

The efficacy of Ryzumvi for the reversal of mydriasis was demonstrated in two, randomized, double-masked, vehicle-controlled trials; MIRA-2 (NCT#04620213) and MIRA-3 (NCT#05134974). A total of 553 subjects, aged 12 to 80 years, who had mydriasis induced by instillation of phenylephrine or tropicamide or a combination of hydroxyamphetamine hydrobromide and tropicamide (Paremyd ® ) were randomized. Subjects with light and dark irides were included in both trials. Two drops (study eye) or one drop (fellow eye) of Ryzumvi or placebo (vehicle) were administered one hour after instillation of the my...

The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates...

None. None. ( 4 )

Uveitis: Ryzumvi is not recommended to be used in patients with active ocular inflammation. ( 5.1 ) 5.1 Uveitis Ryzumvi is not recommended when active ocular inflammation (e.g., iritis) is present because adhesions (synechiae) may form between the iris and the lens. 5.2 Potential for Eye Injury or Contamination To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface. 5.3 Use with Contact Lenses Contact lens we...