Pilocarpine hydrochloride 0.4% eye drops solution (Qlosi, Orasis Pharmaceuticals) has been approved by the FDA for the treatment of presbyopia in adults.

Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping visual abilities. Recently, the US Food and Drug Administration (FDA) approved QLOSI™ (ophthalmic drug pilocarpine hydrochloride solution) 0.4% for the treatment of presbyopia in adults. QLOSI is expected to be on the market in the US in the first half of 2024.

QLOSI are prescription eye drops that can be used daily or as needed, up to twice daily. QLOSI demonstrated efficacy after 20 minutes of dosing and can last up to 8 hours, measured on day 15, to improve near vision without affecting distance or night vision. QLOSI is a preservative-free formulation of pilocarpine, a proven eye care treatment, designed to achieve the optimal balance between effectiveness, safety, and user comfort.

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."

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 here.

Reference
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?tc=eml_cleartime.