Viatris, a global healthcare company, has announced that the US Food and Drug Administration (FDA) has approved Ryzumvi (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults. Ryzumvi is currently approved in the United States for the treatment of pharmacologically-induced mydriasis and is the only commercially available FDA-approved product for that use. This approval expands the product’s indications to include presbyopia
Viatris is exploring the potential for a partner in the United States to commercialize Ryzumvi for the treatment of presbyopia.
Opus Genetics and Viatris (through an affiliated entity) are parties to a global licensing agreement which provides for the development of phentolamine ophthalmic solution 0.75% and grants exclusive rights to Viatris to commercialize the product in the United States.
Presbyopia is the gradual loss of near focusing ability due to aging, that typically becomes noticeable in the early to mid-40s. It is a nearly universal condition that, when uncorrected, contributes significantly to vision-related disability. Presbyopia leads to symptoms like eye strain and blurred near vision, impacting daily tasks and productivity.
Usage
Ryzumvi (phentolamine ophthalmic solution) 0.75% is indicated for – Treatment of presbyopia in adults; and Treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide) in adults and pediatric patients 3 years of age and older
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
Presbyopia
The most common ocular adverse reactions reported in > 5% of subjects were conjunctival hyperemia (21%) and instillation site irritation (16%).
The most common ocular adverse reactions reported in > 5% of subjects were instillation site discomfort including pain, stinging, and burning (16%) and conjunctival hyperemia (12%). The only non-ocular adverse reaction reported in > 5% of subjects was dysgeusia (6%). The majority of the adverse reactions were mild, transient and self-resolving.
Viatris is a global healthcare company with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. It is headquartered in the US, with global centers in Pittsburgh, Shanghai and Hyderabad, India.
