US FDA Approves Vuity for Presbyopia in Adults

The US Food and Drug Administration has approved Vuity eye drops (phentolamine 0.75% solution) for the treatment of presbyopia in adults, according to an announcement by Opus Genetics. The drug was previously approved to treat drug-induced pupil dilation, and the new approval expands its scope of use. The approval was based on the Phase 3 VEGA-2 and VEGA-3 trials.

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• The US Food and Drug Administration has approved phentolamine 0.75% solution (Vuity) for the treatment of age-related presbyopia in adults, according to Opus Genetics.

  «announced that the United States Food and Drug Administration (FDA) has granted approval for phentolamine ophthalmic solution 0.75% for the treatment of age-related presbyopia in adults»

  visionmonday.com • Eyewire+
• The drug is currently approved to treat drug-induced pupil dilation in adults and children aged 3 years and older.

  «The medication is currently approved to treat pharmacologically induced mydriasis, or pupil dilation, in adults and children ages 3 years or older.»

  Medscape
• The approval was based on the Phase 3 VEGA-2 and VEGA-3 trials.

  «Phentolamine 0.75% (Ryzumvi) won FDA approval for presbyopia based on the phase 3 VEGA-2 and VEGA-3 trials.»

  The American Journal of Managed Care
• The approval came on a supplemental drug application, and it expands the product's scope of use.

  «This approval expands the indication for the product, which has been marketed in the U.S.»

  Eyewire+ • visionmonday.com

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