FDA Approves Pilocarpine Hydrochloride Ophthalmic Solution 0.4% for Presbyopia

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Results from the phase 3 NEAR-1 and NEAR-2 clinical trials show consistent efficacy and tolerability of the preservative-free, low-dose eye drop in patients with presbyopia.

The US Food and Drug Administration (FDA) has approved pilocarpine hydrochloride ophthalmic solution 0.4% (QLOSI™) for the treatment of presbyopia, or blurry age-related near vision, in adult patients.1

Announced by Orasis Pharmaceuticals on October 18, the FDA approval of the preservative-free, low-dose eye drop was based on strong efficacy, safety, and tolerability reported in the pivotal phase 3, NEAR-1, and NEAR-2 clinical trials. The drop demonstrated efficacy in clinical trials 20 minutes after administration and could up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision in patients with presbyopia.

“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, OD, director of cornea and external disease, Kentucky Eye Institute.1 “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 eye drop is a preservative-free formulation of low-dose pilocarpine and a multi-faceted vehicle designed to achieve an optimal balance between efficacy, safety, and comfort, according to Orasis. It can be used daily, or as needed, up to twice a day. Near visual acuity is improved by pupil modulation, leading to a pinhole effect and an increase in depth of field.

The NEAR-1 and NEAR-2 trials included ≥600 patients, which evaluated the efficacy and safety of pilocarpine hydrochloride ophthalmic solution 0.4%. Both trials met their primary and key secondary endpoints on Day 8. Those treated with the ophthalmic solution achieved statistically significant ≥3-line gain in distance-corrected near visual acuity (DCNVA) and no loss of ≥1-line in distance visual acuity.

Safety outcomes showed the most common treatment-related adverse events of headache and instillation pain occurred in 6.8% and 5.8% of participants, respectively. In all treated with the ophthalmic solution, only 1.3% reported moderate treatment-related adverse events, with all other adverse events considered mild.

“Providers are eager to improve outcomes for their presbyopia patients, who often struggle with the inflexibility of current treatment options,” said Sheri Rowen, MD, medical director, NVision Eye Centers. “Based on the statistically significant efficacy and tolerability demonstrated in the two pivotal clinical trials with such a minimum effective dose, QLOSI's results reinforce the important role of formulation in reimagining a new approach to treating these patients.”

According to the release, pilocarpine hydrochloride ophthalmic solution 0.4% is expected to be commercially available in the US in the first half of 2024.1

Previously, in November 2021, the FDA approved AbbVie’s pilocarpine HCI ophthalmic solution 1.25% (VUITY), marking the first approved eye drop for the treatment of presbyopia.2 Data from the phase 3 GEMINI 1 & GEMINI 2 clinical trials showed the solution worked as early as 15 minutes and lasted for ≤6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision in patients with presbyopia.

"Each presbyopia patient has different visual demands, yet all are impacted in the ability to perform day-to-day functions," said Richard Lindstrom, MD, founder and attending surgeon emeritus, Minnesota Eye Consultants, in a statement.1 "It's very exciting to see a novel, new treatment category emerging for this challenging patient population which will give eye care professionals more options throughout the presbyopic journey."


  1. Orasis Pharmaceuticals announces FDA approval of QLOSITM (Pilocarpine Hydrochloride Ophthalmic Solution) 0.4% for the treatment of Presbyopia. Orasis. October 18, 2023. Accessed October 18, 2023.
  2. Iapoce C. FDA approves Pilocarpine HCI ophthalmic solution 1.25% for treatment of Presbyopia. HCP Live. November 1, 2021. Accessed October 18, 2023.