FDA Approves Orasis Pharmaceuticals' Eye Drop Qlosi for Presbyopia

FDA Approves Orasis Pharmaceuticals' Eye Drop Qlosi for Presbyopia

October 19, 2023

Orasis Pharmaceuticals announced the approval of Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% by the FDA for the treatment of presbyopia. The anticipated availability of Qlosi in the United States is slated for the first half of 2024.

Qlosi, a prescription eye drop, can be used on a daily basis or as needed, up to twice per day. It has demonstrated its efficacy within 20 minutes after administration and can maintain its effects for up to 8 hours, as observed on day 15. This enhancement in near vision does not compromise distance or night vision. Qlosi is a preservative-free formulation of pilocarpine carefully designed to strike the right balance between effectiveness, safety, and comfort. By modulating the pupil, it enhances near visual acuity, creating a "pinhole effect" and expanding the depth of field, thereby improving the ability to focus on nearby objects.

“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.”

The FDA's approval is grounded in the outcomes of the phase 3 NEAR-1 and NEAR-2 clinical trials, which engaged over 600 patients. These trials assessed the effectiveness and safety of Qlosi and both successfully met their primary and key secondary endpoints by Day 8. They achieved a statistically significant gain of 3 lines or more in distance-corrected near visual acuity (DCNVA) without any loss of 1 line or more in distance visual acuity. The most common treatment-related adverse events, namely headache and instillation site pain, occurred in 6.8% and 5.8% of participants, respectively. Among all Qlosi users, 1.3% reported moderate treatment-related adverse events, with all other adverse events being of a mild nature.

“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.”

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