People experiencing aging-related farsightedness now have an additional topical treatment option as the FDA has expanded the approval of phentolamine ophthalmic solution 0.75% (Ryzumvi) to include presbyopia.
Mechanism of Action
This eye drop formulation is designed to enhance near vision while preserving distance vision. It reduces pupillary dilation through a sympatholytic mechanism that does not engage the ciliary muscle.
Previous Approvals
Phentolamine ophthalmic solution initially received FDA approval for treating mydriasis (abnormal or persistent pupil dilation) caused by adrenergic agonists or parasympatholytic agents, applicable in both adults and children aged 3 years or older.
Clinical Support
The basis for the expanded approval for treating presbyopia stems from the phase III VEGA-2 and VEGA-3 clinical trials. VEGA-2 assessed phentolamine eye drops in conjunction with topical pilocarpine versus placebo, while VEGA-3 exclusively evaluated phentolamine eye drops against placebo. Both studies met their primary endpoints.
Trial Details
Reported this summer, VEGA-3 included 569 adults aged 40-64 years with binocular photopic distance-corrected near visual acuity (DCNVA) of 20/50 or worse. Participants were randomly assigned to receive the 0.75% phentolamine eye drops or placebo, applied nightly. The primary endpoint assessed the percentage of patients achieving ≥3 lines of DCNVA with <5-letter loss in best-corrected distance visual acuity (BCDVA) on day 8, evaluated 12 hours post-dose.
The results indicated that 27% of patients receiving phentolamine eye drops met this primary endpoint, compared to 12% of the placebo group (P<0.0001). Notably, the difference in the primary endpoint reached statistical significance within the first hour after dosing (21% vs 6%, P<0.001).
Adverse Effects
Most adverse events were mild and transient, with the most common being conjunctival hyperemia (26%), site irritation (15%), eye irritation (5.6%), dysgeusia (5.9%), and headache (2.6%).
Usage Recommendations
Phentolamine ophthalmic solution 0.75% is not advised for individuals with active ocular inflammation. To prevent eye injury or contamination, avoid direct contact of the vial tip with the eye. Contact lens wearers should remove their lenses before applying the drops and wait at least 10 minutes before reinserting them.
Other Recent Approvals
In recent years, the FDA has approved several other eye drop treatments for presbyopia, including pilocarpine hydrochloride 1.25% (Vuity) in 2021, pilocarpine hydrochloride 0.4% (Qlosi) in 2023, aceclidine 1.44% (Vizz) expected in 2025, and carbachol/brimonidine tartrate (Yuvezzi) earlier this year.
Disclaimer: This content is for informational purposes only and is not intended as medical advice. Please consult a healthcare professional for diagnosis and treatment options.
Fuente: https://www.medpagetoday.com/ophthalmology/generalophthalmology/123467
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