ORASIS PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF QLOSI™ (PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION) 0.4% FOR THE TREATMENT OF PRESBYOPIA

QLOSI™ is a preservative-free, low-dose eye drop for presbyopia, which consistently demonstrated efficacy, safety, and tolerability in two pivotal Phase 3 trials

Ponte Vedra, FL, October 18, 2023 – Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today 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 Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. “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 (pronounced CLOH-see) 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 8 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.

“Patients experiencing age-related, blurry near vision are in need of flexible treatment options to manage their presbyopia in ways that work for them with fewer tradeoffs,” said Paul Karpecki, O.D., FAAO, Director, Cornea and External Disease, Kentucky Eye Institute, and Associate Professor, University of Pikeville, Kentucky College of Optometry. “In clinical trials, QLOSI demonstrated the optimal balance of efficacy, safety, and tolerability, and 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.”

You can read the remainder of the press release here in the news page the Orasis website.

Shared by Tyler Stowater, board member of Orasis Pharmaceuticals.