Viatris Inc. announced the U.S. commercial launch of 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 in the United States. RYZUMVI is now the only U.S. commercially available FDA-approved eye drop to reverse dilation.1
According to the American Academy of Ophthalmology and the American Optometric Association, clinical practice guidelines recommend dilation as a standard of care.2,3 Dilation allows eye care professionals to identify both common and serious eye health issues, including signs of systemic disease.2,3 The average time of dilation lasts three to eight hours, but can last up to 24 hours in some people.4,5 Prolonged dilation may lead to patients refusing dilation.6,7
Comprehensive dilated eye exams play a vital role in detecting potential vision-impairing ophthalmic conditions such as cataracts and potentially blinding diseases like glaucoma, diabetic retinopathy, and age-related macular degeneration.2,3 Additionally, comprehensive dilated eye exams can uncover evidence of systemic diseases like diabetes, rheumatoid arthritis, and hypertension.2,3
The U.S. Food and Drug Administration (FDA) approved RYZUMVI in September 2023. RYZUMVI was evaluated across 2 randomized, vehicle-controlled, double-masked MIRA-2 and MIRA-3 clinical trials in which patients (N=553) aged 12 to 80 years who had mydriasis induced by instillation of phenylephrine, tropicamide, or PAREMYD (hydroxyamphetamine hydrobromide and tropicamide) were administered 2 drops (in the study eye) or 1 drop (in the fellow eye) of either RYZUMVI or placebo one hour after instillation of the mydriatic agent.
The onset of action of RYZUMVI generally occurs in 30 minutes. In the MIRA-2 and MIRA-3 clinical trials, at 90 minutes after administration, 49% and 58% of patients administered 2 drops of RYZUMVI returned to ≤ 0.2 mm of baseline pupil diameter compared to 7% and 6% of patients administered placebo, respectively. In the MIRA-2 trials' placebo group, 34% of patients were still dilated (had not returned to ≤ 0.2 mm of baseline pupil diameter) at 24 hours. In the MIRA-3 trials' placebo group, 28% of patients were still dilated at 24 hours.1
RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis). 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. Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses.1
The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%).
For more information on RYZUMVI, visit https://www.ryzumvi.com/.
About Pharmacologically-Induced Mydriasis
An estimated 100 million eye dilations are conducted every year in the U.S. to examine the retina (back-of-the-eye) either for routine check-ups, disease monitoring or surgical procedures.8 Recovery from pharmacologically-induced mydriasis can take three to eight hours, and sometimes lasts 24 hours.4,5
About RYZUMVI™ (Phentolamine Ophthalmic Solution) 0.75%
Indication
RYZUMVI™ (phentolamine ophthalmic solution) 0.75% is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.
Important Safety Information
Warnings and Precautions
- Uveitis: RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis).
- 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.
- Use with Contact Lenses: Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses.
Adverse Reactions
The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%).
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