Viatris, Inc. has received FDA approval for RYZUMVI (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults.
This marks the second indication the eye drop has received regulatory approval for in the United States.
So! Where shall we begin?
With the drop itself: RYZUMVI (pronounced Reh-soom-VEE) is an antimicrobial, preservative-free, topical eye drop formulation.
- Its active ingredient: phentolamine, which is key in its mechanism of action (MOA) as a reversible, nonselective alpha-1 and alpha-2 adrenergic agonist with antimicrobial properties.
How it works: When topically administered, the solution reduces pupil size (diameter) by blocking the alpha-1 receptors found on the radial iris dilator muscles (activated by the alpha-1 adrenergic receptors)—without affecting the ciliary muscle.
And you mentioned this is the second indication for the drop, correct?
Indeed. RYZUMVI initially entered the U.S. regulatory and commercial market in 2023 and 2024, respectively, as the first and only treatment for reversal of mydriasis (RM).
Also take note: The drop was originally developed by Ocuphire Pharma, Inc. (which Viatris acquired in 2023) and is the subject of a global licensing agreement between Opus Genetics and Viatris.
Gotcha. So, let’s talk presbyopia dosing.
RYZUMVI is packaged in a single-dose vial containing phentolamine 0.75.%.
Per its prescribing information (PI), one drop should be instilled in each eye once daily at night among adult presbyopes.
- See here for how this compares to its RM dosing.
Can contact lenses be worn when dosing?
No. The PI advises contact lens wearers to remove their lenses prior to drop instillation and only reinsert after waiting 10 minutes post-administration.
Now for a quick review of the supporting data for this approval.
The drop’s supplemental new drug application (sNDA) included positive efficacy data from two randomized, double-masked, placebo-controlled, multicenter phase 3 trials:
- VEGA-2 (NCT05646719)
- VEGA-3 (NCT06542497)
Importantly: Both studies have met their primary and secondary endpoints.
Give me specifics.
As we reported last year, topline data found that RYZUMVI led to:
- A statistically significant (27.2%) number of patients achieving a ≥15-letter improvement in binocular distance-corrected near visual acuity (DCNVA)
- 20.6% of patients achieving a ≥15-letter Early Treatment Diabetic Retinopathy Scale (ETDRS; ≥3-line) gain in DCNVA at 1-hour post-dose on Day 1
Any adverse events reported?
Based on our prior reporting: There were no treatment-related serious adverse events (AEs) as well as no evidence of tachyphylaxis across the studies’ 6-week periods.
The most common treatment-emergent AEs (≥5%): conjunctival hyperemia (21%) and instillation site irritation (16%).
Next up: contraindications and warnings/precautions.
No contraindications for patients to keep in mind. As for warnings/precautions, the PI notes uveitis as a cause for concern.
Specifically: “RYZUMVI is not recommended when active ocular inflammation (e.g., iritis) is present because adhesions (synechiae) may form between the iris and the lens.”
And as with any other topical drop, “care should be taken to avoid touching the vial tip to the eye or any other surface,” so as to avoid the potential for eye injury or contamination.
Duly noted. So what’s next?
Commercial launch planning.
While RYZUMI is already commercially available in the U.S. for RM, Viatris is currently on the hunt for a U.S. partner to support RYZUMVI’s presbyopia indication.
As such: No timeframe was provided for when U.S. adult presbyopes may be able to access this prescription-based drop.
Stay tuned!