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.