Orasis Pharmaceuticals has received US Food and Drug Administration (FDA) approval for its QLOSI preservative-free low-dose eye drop for the treatment of presbyopia.
The QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% eye drops were reported to demonstrate efficacy, safety, and tolerability in two pivotal Phase 3 trials involving more than 600 adults.
The company said that the prescription eye drop can be used daily, or as needed, up to twice per day, demonstrating efficacy 20 minutes after administration and can last up to eight hours, without impacting distance or night vision.
'The FDA approval of QLOSI marks a tremendous milestone for Orasis as we continue our mission to provide a flexible treatment option for the millions of people in the U.S. living with presbyopia, or blurry near vision,' said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals.
QLOSI is expected to be commercially available in the U.S. in the first half of 2024.
