The US Food and Drug Administration (FDA) has approved Viatris’ Ryzumvi (phentolamine ophthalmic solution 0.75%) to treat presbyopia in adults.
In the US, Ryzumvi is already marketed as the sole authorised treatment for pharmacologically-induced mydriasis.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Under a global licensing agreement with Opus Genetics, Viatris holds exclusive rights to commercialise phentolamine ophthalmic solution 0.75% across the US.
Following the expanded clearance, the company is exploring opportunities to secure a commercial partner to distribute the solution for presbyopia nationwide.
Presbyopia involves the progressive loss of near-focusing capacity brought on by ageing. The condition typically emerges when individuals reach their early to mid-40s and affects nearly the entire adult population.
When left uncorrected, it contributes significantly to vision-related disability, causing symptoms such as blurred near vision and eye strain that impair everyday activities and productivity.
Safety guidance for the medication instructs contact lens wearers to take out their lenses prior to administering Ryzumvi and wait 10 minutes following the dose before reinserting them.
In clinical studies for presbyopia, the most frequent adverse ocular reactions reported in more than 5% of participants were conjunctival hyperaemia (21%) and instillation site irritation (16%).
Ryzumvi is also indicated to treat pharmacologically-induced mydriasis caused by adrenergic agonists such as phenylephrine or parasympatholytic agents like tropicamide in adults and paediatric patients aged three years and older.
In that indication, the most common reactions exceeding 5% were instillation site discomfort with burning, pain, and stinging (16%), conjunctival hyperaemia (12%), and dysgeusia (6%), with most events remaining self-resolving, mild, and transient.
Viatris maintains its corporate headquarters in the US, alongside global centres situated in Hyderabad, India; Pittsburgh, the US; and Shanghai.
In July 2024, Viatris announced the finalisation of a transaction to divest its over-the-counter (OTC) business, completing the last step in its previously declared $3.37bn divestitures.
