Orasis Pharmaceuticals has secured approval in the US for its age-related blurry vision eye drops, marking the second time the FDA has greenlit a presbyopia treatment.
In 2021, AbbVie secured the first FDA approval for an eye drop for presbyopia, but in 2022 the drugmaker reduced sales and marketing on the product, branded as Vuity. Now, a second-gen attempt at treating the age-related farsightedness condition is going into the trash bin.
Enforcement Report - Week of June 7, 2023
FDA Confirms Paragraph IV Patent Litigation for Pilocarpine Hydrochloride Ophthalmic Solution
SHANGHAI, July 4, 2022 /PRNewswire/ -- Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, today announced that the first patient has been enrolled in a Phase III clinical study evaluating ARVN003, a proprietary pilocarpine formulation leveraging its micro dosing platform Optejet®, as a treatment to temporarily improve vision in adults with presbyopia in China.
NORTH CHICAGO, Ill., April 5, 2022 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia met its primary efficacy endpoint, improving near vision without compromising distance vision at Hour 9 (3 hours after the second drop) on Day 14. Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, VUITY is the first and only eye drop to treat age-related blurry near vision in adults.
NORTH CHICAGO, Ill., Dec. 9, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that VUITY™ (pilocarpine HCl ophthalmic solution) 1.25%, the first and only eye drop approved by the U.S. Food and Drug Administration (FDA) to treat presbyopia, is now available by prescription in pharmacies nationwide. Presbyopia, or age-related blurry near vision, can be diagnosed through a basic eye exam by an eye doctor (optometrist or ophthalmologist) and is a common and progressive eye condition that affects 128 million Americans, or nearly half of the U.S. adult population.
FDA clears AbbVie’s Vuity as first eye drop for presbyopia
AbbVie’s age-related blurry vision drug for aging adults was given the OK by the FDA Friday, making it the first eye drop to treat an eye condition that affects 128 million Americans.nFormerly AGN-190584, the drug has proven a bright spot in Allergan’s pipeline since AbbVie bought it out for $63 billion, which has seen more setbacks than wins.
NORTH CHICAGO, Ill., Oct. 29, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced the U.S. Food and Drug Administration (FDA) approval of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population.