Not actual patients

Rapid eye dilation reversal is now possible1*

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The only available FDA-approved eye drop to rapidly reverse dilation, generally by 90 minutes.1

RYZUMVI™ was evaluated across 2 randomized, vehicle-controlled, double-masked studies 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 (study eye) or 1 drop (fellow eye) of either RYZUMVI or placebo one hour after instillation of the mydriatic agent.1

*The onset of action after administration of RYZUMVI generally occurs in 30 minutes, with the maximal effect seen in 60 to 90 minutes, and the effect lasting at least 24 hours.1

Percentage of subjects
returning to ≤0.2 mm of
baseline pupil diameter1

RYZUMVI™ (phentolamine ophthalmic solution) MIRA-2 efficacy dataRYZUMVI™ (phentolamine ophthalmic solution) MIRA-3 efficacy dataRYZUMVI™ (phentolamine ophthalmic solution) MIRA-2 efficacy dataRYZUMVI™ (phentolamine ophthalmic solution) MIRA-3 efficacy data
11.536

Even at 6 hours, more than 50% of those given a placebo had not had their pupils return to baseline.1

RYZUMVI reversed pupil dilation regardless of whether phenylephrine, tropicamide, or Paremyd® was used.1‑3

  • Phenylephrine Hydrochloride Ophthalmic Solution 2.5%
  • Tropicamide
    Ophthalmic Solution 1%
  • Paremyd® (hydroxyamphetamine hydrobromide and tropicamide) Ophthalmic Solution 1%/0.25%

RYZUMVI was well‑tolerated in clinical studies1‑3

The safety and tolerability of RYZUMVI were studied and evaluated in 642 patients enrolled in the MIRA trials. There are no known contraindications for RYZUMVI.1

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.

Most common adverse reactions1‑3:

  • Instillation site
    discomfort:
  • Conjunctival
    hyperemia:
    No moderate or severe conjunctival hyperemia cases were reported in RYZUMVI clinical trials.
  • Dysgeusia:

Most (>94%) side effects were mild, including eye discomfort and redness. No serious side effects related to RYZUMVI were reported in clinical trials.2,3

There are no retinal-specific warnings or contraindications with RYZUMVI, and no retinal detachment cases were reported in RYZUMVI clinical trials. Warning: RYZUMVI is not recommended when active ocular inflammation (e.g. iritis) is present because adhesions (synechiae) may form between the iris and the lens.1‑3

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%).

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.

Click here for full Prescribing Information.

References: 1. RYZUMVI (phentolamine ophthalmic solution). Prescribing Information. Ocuphire. 2. Viatris. Data on file. OPI-NYXRM-301 (MIRA-2) Clinical Study Report. October 25, 2021. 3. Viatris. Data on file. OPI-NYXRM-302 (MIRA-3) Clinical Study Report. August 10, 2022.