Orasis Pharmaceuticals’ prescription pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi) for presbyopia available in the US

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Orasis Pharmaceuticals announced that its novel corrective eye drop for the treatment of presbyopia in adults (Qlosi; pilocarpine hydrochloride ophthalmic solution 0.4%) is available to prescribe in the US.¹

The topical ophthalmic solution is preservative-free, packaged in single-use vials, and includes dual lubricants—hyaluronic acid and hydroxypropyl methylcellulose—for patient comfort.¹ Patients can enjoy the flexibility of using a single drop per eye for improved near vision for a specific occasion or activity, or up to 2 drops daily for an extended effect lasting up to 8 hours. Prescriptions can be filled through BlinkRx or Medvantx, with free home delivery.

The product’s proprietary EyeQ Formulation is designed to maximize efficacy while minimizing side effects. This is achieved by balancing the lowest approved concentration of pilocarpine at a near-neutral pH for optimal bioavailability.¹

“We are proud to deliver [pilocarpine hydrochloride ophthalmic solution 0.4%], a solution that ushers in a new era in near vision correction and aims to empower patients,” said Elad Kedar, chief executive officer of Orasis Pharmaceuticals. “Our goal has always been to improve near vision for the millions of people struggling with presbyopia, give them a break from readers, and provide eye care professionals with an additional option to optimize care for their patients.”

“When it comes to pharmacologic agents for refractive correction treatments for presbyopia, formulation matters,” noted Richard L. Lindstrom, MD, founder and attending surgeon of Minnesota Eye Consultants and adjunct professor emeritus at the University of Minnesota Department of Ophthalmology, speaking to Ophthalmology Times.

“As we’ve seen with other ophthalmic treatments, even small adjustments in formulation can have a significant impact on efficacy, safety, and tolerability. Products like Qlosi, with its EyeQ Formulation, which minimizes pilocarpine concentrations and closely matches the pH of natural tears, offers a compelling and patient-friendly treatment option,” Lindstrom added.

The FDA approval of the treatment in October 2023 was based on the results from two pivotal Phase 3 clinical trials, NEAR-1 and NEAR-2 (NCT04599933​ and NCT04599972), which evaluated its efficacy, safety, and tolerability in more than 600 adult patients with presbyopia. Both trials met their primary and key secondary end points on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity and no loss of 1-line or more in distance visual acuity. Patients with presbyopia achieved their best results when taking the eye drop consecutively over 2 weeks. All adverse events reported were in the single digits, with headache (6.8%) and instillation site pain (5.8%) being the most commonly reported treatment-related adverse events.^2,3,4

The website www.QlosiECP.com provides resources for both patients and eye care providers, including guidance on usage and details about the Qlosi Clear Start Kit, which is included with the first prescription for each patient.

References

1. Orasis Pharmaceuticals announces novel corrective eyedrop for presbyopia, Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4%, now available to prescribe in the U.S. News release. Orasis Pharmaceuticals. April 7, 2025. Accessed April 7, 2025. https://www.orasis-pharma.com/orasis-pharmaceuticals-strengthens-leadership-team-with-key-hires-to-support-the-launch-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4/

2. Orasis Pharmaceuticals announces FDA approval of Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia. News release. Orasis Pharmaceuticals. October 18, 2023. Accessed April 7, 2025. https://www.orasis-pharma.com/orasis-pharmaceuticals-announces-fda-approval-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4-for-the-treatment-of-presbyopia/

3. Holland E, Karpecki P, Fingeret M, et al. Efficacy and safety of CSF-1 (0.4% pilocarpine hydrochloride) in presbyopia: pooled results of the NEAR Phase 3 randomized, clinical trials. Clin Ther. 2024;46(2):104-113. doi:10.1016/j.clinthera.2023.12.005

4. Qlosi. Prescribing information. Orasis Pharmaceuticals; 2023. Accessed April 7, 2025. https://www.qlosi.com/hubfs/QLOSI%20NDA%20PI_Mar2024_QLO.00021.pdf