Qlosi, Orasis Pharmaceuticals’ preservative-free 0.4% pilocarpine formulation, has received US Food and Drug Administration (FDA) approval for the treatment of presbyopia in adults.
The company’s phase 3 Near-1 and Near-2 clinical trials, involving more than 600 patients, showed Qlosi demonstrated efficacy 20 minutes after administration, achieving statistically significant three-line or more gain in distance-corrected near visual acuity and no loss of one line or more in distance visual acuity. A prescription-only eye drop, Qlosi can be used up to twice per day, and lasts up to eight hours to improve near vision without impacting distance or night vision, said Orasis.
Associate Professor Paul Karpecki, director of cornea and external disease at the Kentucky Eye Institute, said Qlosi’s clinical trials demonstrated the optimal balance of efficacy, safety and tolerability. “The FDA approval marks an exciting next step in being able to provide a new treatment for patients looking for a break from reading glasses or contact lenses.”
The drop is expected to be commercially available in the US in the first half of 2024.
