FDA Approves Qlosi (0.4% Pilocarpine Ophthalmic Solution) for Presbyopia — Onset in 20 Minutes, Lasting Up to 8 Hours

▎WuXi

Edited by the Kant Content Team

Orasis Pharmaceuticals today announced that the U.S. FDA has approved Qlosi (0.4% Pilocarpine HCl Ophthalmic Solution) for the treatment of presbyopia in adults.Qlosi is a preservative-free eye drop for the treatment of presbyopia, demonstrating good efficacy, safety, and tolerability in two pivotal Phase 3 clinical trials.

Presbyopia affects nearly 2 billion people worldwide. Most patients can only choose to wear reading glasses, which is inconvenient for them. In October 2021, Vuity (pilocarpine 1.25% ophthalmic solution) from Allergan, a subsidiary of AbbVie, was approved by the U.S. FDA, becoming the first eye drop treatment approved for presbyopia.

Qlosi is a preservative-free formulation of pilocarpine, a well-established medication for ocular care. Its primary mechanism of action is pupil constriction, which enhances depth of field and improves near and intermediate vision.Qlosi can be used daily or as needed, up to twice a day.

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The FDA approval in the United States was based on the results of the Phase 3 clinical trials NEAR-1 and NEAR-2, which involved more than 600 patients.Both trials met their primary and key secondary endpoints on Day 8, significantly increasing the proportion of patients who gained three additional lines on the eye chart.Within one hour after receiving the first dose, 40% of patients read three additional lines, and this proportion reached 50% after receiving the second dose (p

Moreover,Qlosi significantly improved the proportion of patients who could read three additional lines on the eye chart on Day 1 and Day 15 of treatment. Subjects experienced vision improvement as early as 20 minutes after receiving the treatment, with effects lasting up to 8 hours.Meanwhile, the subjects did not lose one or more lines of distance vision. The most common treatment-related adverse events were headache and infusion site pain, occurring in only 6.8% and 5.8% of subjects, respectively. Among all Qlosi subjects, only 1.3% reported moderate treatment-related adverse events. All other adverse events were mild.

[1] Orasis Pharmaceuticals Announces FDA Approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia. Retrieved October 18, 2023, from https://www.prnewswire.com/news-releases/orasis-pharmaceuticals-announces-fda-approval-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4-for-the-treatment-of-presbyopia-301959581.html