Orasis gains FDA approval for presbyopia eye drops, following in AbbVie’s footsteps

18 Oct 2023
endpts.com
Phase 3Drug ApprovalNDA
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. The OK for Qlosi comes a few days ahead of the FDA decision deadline, which is Sunday. The eye drops, which can be dosed up to twice daily, will become available in the first half of next year, Orasis said. AbbVie snagged the first FDA clearance for blurry vision eye drops in 2021, with Vuity, but the Chicago-area Big Pharma took a $770 million pre-tax impairment charge last fall when it decided to pull back on its big sales and marketing spend . The pharma giant then axed a second-generation presbyopia asset, Endpoints News reported earlier this year. Meanwhile, other companies have candidates in Phase III, including Viatris-partnered Ocuphire Pharma, Lenz Therapeutics and Visus Therapeutics , which plans to file an NDA in the second half of 2024, pending results from another trial slated to read out later this year.
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