FDA Grants Approval to Orasis Pharmaceuticals for QLOSI™ in the Management of Presbyopia

Orasis Pharmaceuticals, a burgeoning player in the ophthalmic pharmaceutical sector with a goal of revolutionizing vision enhancement, proudly announced the U.S. Food and Drug Administration (FDA) approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. QLOSI is expected to hit the U.S. commercial market in the first half of 2024.

Orasis Pharmaceuticals, expressed his satisfaction, saying, "The FDA's approval of QLOSI is a significant achievement for Orasis as we work towards our mission of offering a versatile treatment option for the millions of Americans dealing with presbyopia, which causes near vision to become blurry. This accomplishment owes its gratitude to the dedication of the Orasis team, our strategic partners, clinical investigators, and the invaluable participation of patients in our clinical trials."

QLOSI, pronounced as "CLOH-see," is a prescription eye drop suitable for daily or as-needed use, up to twice a day. Importantly, QLOSI demonstrated its efficacy within just 20 minutes after administration and maintained its effects for up to 8 hours, as demonstrated on day 15, enhancing near vision without negatively affecting distance or night vision. This innovative product is a preservative-free formulation of pilocarpine, a well-established therapeutic for eye care, meticulously designed to strike the ideal balance between effectiveness, safety, and comfort.

Paul Karpecki, O.D., FAAO, Director of Cornea and External Disease at the Kentucky Eye Institute and Associate Professor at the University of Pikeville, Kentucky College of Optometry, emphasized the need for flexible treatment options for patients grappling with age-related, blurry near vision due to presbyopia. He stated, "QLOSI's clinical trials have shown that it offers an optimal blend of effectiveness, safety, and tolerability. The FDA's approval is a significant step forward in providing a new treatment choice for patients who seek respite from reading glasses or contact lenses."

The FDA's approval of QLOSI is grounded in the results obtained from the Phase 3 NEAR-1 and NEAR-2 clinical trials, which collectively involved over 600 patients. These trials evaluated the effectiveness and safety of QLOSI, with both trials successfully meeting their primary and key secondary endpoints on Day 8. Notably, they achieved statistically significant improvements of 3 lines or more in distance-corrected near visual acuity (DCNVA) without any decline of 1 line or more in distance visual acuity. The most common treatment-related side effects, namely headaches and instillation site pain, were experienced by only 6.8% and 5.8% of participants, respectively. A mere 1.3% of QLOSI users reported moderate treatment-related side effects, with all other adverse events being mild.

Sheri Rowen, M.D., FACS, FWCRS, PCEO, Medical Director at NVision Eye Centers in Newport Beach, CA, shared her insights, saying, "Healthcare providers are eager to enhance the outcomes for their presbyopia patients, who often struggle with the limitations of current treatment options. Patients will be thrilled to have the option to tailor their usage of low-dose pilocarpine to suit their individual visual needs. The results of QLOSI, with its statistically significant effectiveness and tolerability shown in two pivotal clinical trials using such a minimal effective dose, underscore the pivotal role of innovation in redefining the approach to treating these patients."

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