October 19, 2023
PONTE VEDRA, Fla. — Orasis Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. Qlosi is expected to be commercially available in the U.S. in the first half of 2024.
“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 Chief Executive Officer Elad Kedar. “I am grateful to the Orasis team, our strategic partners, clinical investigators, and patients who participated in our clinical trials, all of whom made this achievement possible.”
Qlosi is a prescription eye drop that can be used daily, or as needed, up to twice per day. Qlosi demonstrated efficacy 20 minutes after administration and can last up to eight hours, as measured on day 15, to improve near vision without impacting distance or night vision. Qlosi is a preservative-free formulation of pilocarpine, an established eye care therapeutic, designed to achieve an optimal balance between efficacy, safety, and comfort.
The FDA approval is based on results from the Phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of Qlosi. Both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of 1-line or more in distance visual acuity. The most common treatment-related adverse events of headache and instillation site pain occurred in only 6.8% and 5.8% of participants, respectively. Of all Qlosi participants, only 1.3% reported moderate treatment-related adverse events. All other adverse events were mild.
For more information about Qlosi and full prescribing information, visit www.Qlosi.com.
