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Viatris launches RYZUMVI in the United States

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5 min read

Viatris Inc. announced the U.S. commercial launch of RYZUMVI (phentolamine ophthalmic solution) 0.75%, indicated to treat pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholytic agents.

Wasn’t this product developed by Ocuphire Pharma?

Good memory!

Indeed it was… however, Viatris acquired both Oyster Point Pharma, Inc. and Famy Life Sciences back in January 2023—giving the company ownership of not just RYZUMVI (originally developed under the name Nyxol), but also Tyrvaya (the first and only FDA-approved nasal spray for dry eye disease [DED] treatment).

These acquisitions became part of the company’s newly-established Viatris Eye Care division.

Now let’s talk about this medication.

Approved by the FDA in September 2023, RYZUMVI (pronounced Reh-soom-VEE) is an antimicrobial, preservative-free, topical eye drop formulation.

Phentolamine, the solution’s active ingredient, is key in its mechanism of action (MOA) as a relatively non-selected alpha-1 and alpha-2 adrenergic agonist.

Note: Pupil dilation is largely controlled by the radial iris dilator muscles around the pupil, which are activated by the alpha-1 adrenergic receptors.

Tell me more about this MOA.

Phentolamine works to reversibly bind the alpha-1 adrenergic receptors located on the iris dilator muscle, potentially resulting in a reduction of the pupil diameter.

From there, it “directly antagonizes the mydriatic effect of an α-1 adrenergic agonist,” thus causing an indirect reversal of mydriasis (RM).

And its recommended dosage?

According to RYZUMVI’s prescribing information (PI), the following dosages are advised:

  • Adult and pediatric patients (age 12+)
    • One to two drops are to be instilled in each dilated eye following the completion of an ophthalmic exam or procedure to reverse mydriasis.
  • Pediatric patients (ages 3 to 11)
    • One drop is to be instilled in each dilated eye following completion of an ophthalmic exam or procedure to reverse mydriasis.

See here for the complete prescribing information.

How long does it take to work?

Per Viatris: “The onset of RYZUMVI generally occurs in 30 minutes.”

Any clinical data?

Its FDA approval was based on data from 600+ patients who participated in the MIRA clinical trial program:

Go on…

The eye drop demonstrated a favorable safety and tolerability profile for RM across all three MIRA trials, with the MIRA-4 study also finding that it performed favorably.

Give me some details.

For both MIRA-2 and MIRA-3, 90 minutes following eye drop 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,” Viatris reported.

What about in the placebo group?

For MIRA-2, 34% of participants in the placebo group were still dilated at 24 hours (meaning they had not returned to ≤ 0.2 mm of baseline pupil diameter).

And in the MIRA-3 placebo group, 28% of participants were still dilated at 24 hours.

Any notable adverse events?

A few… with the most common ocular adverse reactions (occurring in less than 5% of participants) include:

  • Instillation site discomfort (16%)
    • Pain
    • Stinging
    • Burning
  • Conjunctival hyperemia (12%)

Note: Dysgeusia (6%) was the only non-ocular adverse reaction.

How about warnings or precautions?

The PI warns against the use of RYZUMVI in patients with active ocular inflammation, as “adhesions may form between the iris and the lens.”

Other precautions include avoiding the potential for eye injury or contamination as well as contact lens use: “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.”

Gotcha. And the significance of this?

RYZUMVI is now the only commercially available treatment option in the United States indicated for RM.

Lastly… where can I find it?

Per the eye drop’s product website, RYZUMVI is now available through the following authorized distributors:

*Featured image courtesy of SIGMA Pharmaceuticals