Viatris Inc. (Nasdaq: VTRS), a global healthcare company, announced today that the U.S. Food and Drug Administration (FDA) has cleared RYZUMVI (phentolamine ophthalmic solution 0.75%) for treating presbyopia in adults. RYZUMVI already holds U.S. approval for pharmacologically-induced mydriasis and remains the sole FDA-cleared product available commercially for that purpose. The new clearance broadens the product's approved uses to cover presbyopia.

Viatris is seeking a U.S. partner to bring RYZUMVI to market for presbyopia treatment.

About Opus Genetics and Viatris Collaboration Opus Genetics and Viatris Inc. (via an affiliated entity) operate under a global licensing pact covering development of phentolamine ophthalmic solution 0.75% and granting Viatris exclusive U.S. commercialization rights.

About Presbyopia Presbyopia involves the progressive decline in near-focus ability tied to aging and often appears in the early to mid-40s. This widespread condition, when left uncorrected, adds markedly to vision-related disability. It produces eye strain and blurred near vision that hinder everyday activities and work output.

INDICATIONS AND USAGE RYZUMVI (phentolamine ophthalmic solution) 0.75% is indicated for treatment of presbyopia in adults and for reversal of pharmacologically-induced mydriasis caused by adrenergic agonists (such as phenylephrine) or parasympatholytic agents (such as tropicamide) in adults and children aged 3 years and older.

Treatment of presbyopia in adults
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

IMPORTANT SAFETY INFORMATION

Warnings and Precautions Uveitis: RYZUMVI should not be used in patients with active ocular inflammation (e.g., iritis). Potential for Eye Injury or Contamination: Avoid touching the vial tip to the eye or any surface to prevent injury or contamination. Use with Contact Lenses: Lens wearers must remove lenses before applying RYZUMVI and wait 10 minutes after dosing before reinserting them.

Adverse Reactions Presbyopia: The most frequent ocular reactions seen in more than 5% of subjects were conjunctival hyperemia (21%) and instillation site irritation (16%). Pharmacologically-induced Mydriasis: The most common ocular reactions in more than 5% of subjects were instillation site discomfort including pain, stinging, and burning (16%) and conjunctival hyperemia (12%). The sole non-ocular reaction reported in more than 5% of subjects was dysgeusia (6%). Most reactions were mild, brief, and resolved on their own.

Please see complete Prescribing Information.

About Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet patient needs around the world by acting decisively with ingenuity and resolve. Whether developing new medicines, maintaining resilient supplies of needed therapies, or pursuing bold innovation, we deliver solutions that work at scale and last. We are purpose-built to make an impact with a broad portfolio spanning generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India.

Forward-Looking Statements This press release includes statements that constitute forward-looking statements. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements about the approval of RYZUMVI for the treatment of presbyopia in adults and Viatris exploring the potential for a partner in the United States to commercialize RYZUMVI for the treatment of presbyopia. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

SOURCE Viatris Inc.