Viatris has received approval from the US Food and Drug Administration (FDA) to expand the indication for RYZUMVI (phentolamine ophthalmic solution 0.75%) to include the treatment of presbyopia in adults.
RYZUMVI was previously approved in the United States for treating pharmacologically induced mydriasis, or pupil dilation caused by certain medications. The company describes it as the only commercially available FDA-approved product for this use.
With the expanded indication, RYZUMVI 0.75% is now approved for treating presbyopia in adults, as well as pharmacologically induced mydriasis caused by adrenergic agonists, such as phenylephrine, or parasympatholytic agents, such as tropicamide, in adults and paediatric patients aged three years and older.
Presbyopia is an age-related decline in the eye’s ability to focus on nearby objects. The condition typically becomes noticeable in the early to mid-40s and can cause blurred near vision and eye strain, affecting daily activities and productivity. When uncorrected, it is a significant contributor to vision-related disability.
Viatris said it is exploring the possibility of partnering with another company in the United States to commercialise RYZUMVI for presbyopia.
Opus Genetics and Viatris, through an affiliated entity, are parties to a global licensing agreement covering the development of phentolamine ophthalmic solution 0.75%. The agreement grants Viatris exclusive rights to commercialise the product in the United States.
Viatris to Acquire Pacira BioSciences for $1.65 Billion
Earlier this month, Viatris entered into a definitive agreement to acquire Pacira BioSciences for $36.50 per share in cash, representing an aggregate equity value of approximately $1.65 billion.
Pacira’s portfolio includes two established, high-margin, patent-protected products marketed in the United States: EXPAREL (bupivacaine liposome injectable suspension) for acute postsurgical pain and ZILRETTA (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis knee pain.
Viatris plans to leverage its intellectual property expertise and track record of extending product lifecycles and sustaining sales following the entry of competition to maximise the long-term value of Pacira’s portfolio. The company also expects to expand the products’ reach into select markets through its global infrastructure.
“The pending acquisition of Pacira BioSciences is an important step in advancing our strategy to build our innovative medicines business,” said Scott A. Smith, CEO, Viatris.
Smith said the addition of EXPAREL and ZILRETTA positions the company as a leader in non-opioid pain management therapies.
The transaction is expected to close by the end of 2026. Upon completion, Pacira will become a wholly owned subsidiary of Viatris.
Headquartered in the United States, Viatris has global centres in Pittsburgh, Shanghai and Hyderabad, India.
