Spotlight on QLOSI™

This Spotlight Series article is editorially independent content.

Presbyopia, the age-related loss of near vision, typically presents after age 40 as the crystalline lens of the eye gradually stiffens and loses flexibility. Worldwide, nearly 2 billion people—and more than 128 million in the United States—are affected by presbyopia. Those with the condition often experience blurred near vision when performing everyday activities. Presbyopia cannot be prevented or reversed, and it tends to worsen gradually over time. Many existing treatment options can be either cumbersome or invasive, leaving a significant unmet need for improving quality of life for individuals with this condition.^1,2

Qlosi™: Unique EyeQ Formulation™

Qlosi (pilocarpine hydrochloride ophthalmic solution; Orasis Pharmaceuticals) 0.4% is a new cholinergic agonist indicated for the treatment of presbyopia in adults. Approved by the FDA in 2023, this novel, preservative-free, low-dose eye drop is now available to prescribe in the United States. It is the only FDA-approved eye drop formulated with the lowest effective concentration of pilocarpine to deliver optimal results.^1-3

Qlosi incorporates the company’s proprietary EyeQ Formulation, designed to maximize efficacy while minimizing side effects. This is achieved by using the lowest approved concentration of pilocarpine at a near-neutral pH for optimal bioavailability. The formulation maintains an ideal pupil size of 2 to 3 mm, improving visual acuity by creating a “pinhole effect.” Additionally, Qlosi includes dual lubricating agents (hyaluronic acid and hydroxypropyl methylcellulose) for ocular comfort.^3-5

Efficacy Data

Qlosi consistently demonstrated efficacy across phase 3 studies. NEAR-1 and NEAR-2 were multicenter, randomized, double-masked, vehicle-controlled, parallel group, phase 3 studies that enrolled 613 patients aged 45 to 64 years with presbyopia. Patients instilled 1 drop of Qlosi (n=309) or vehicle (n=304) into each eye once in the morning and a second dose 2 to 3 hours later each day for 2 weeks. Ophthalmic assessments were conducted at various time points on days 1, 8, and 15.^1,4

The primary efficacy end point was the achievement of a ≥3-line improvement from baseline in distance-corrected near visual acuity at 40 cm with no loss in corrected distance visual acuity ≥1-line at 4 meters on day 8 at 1 hour post-dose 1. Key secondary efficacy end points followed the same criteria on day 8 at 2 hours post-dose 1 and at 1 and 2 hours post-dose 2. Both studies met their primary and key secondary end points on day 8.¹

Patients in the Qlosi arm achieved the primary end point compared with patients in the vehicle arm (40.1% vs 19.1%, respectively; P<.0001). Key secondary end points also showed significant improvement at all tested times. FIGURE 1 shows the percentage of responders for each time point at day 15.^1,4

A separate analysis of the NEAR-1 and NEAR-2 studies showed that 8 of 10 patients treated with Qlosi experienced improved functional near vision (20/40 or better) on day 15 with binocular vision. After 2 doses of Qlosi, this improvement was maintained for up to 8 hours (see FIGURE 2).⁶

 Safety and Tolerability

Qlosi demonstrated a well-established safety and tolerability profile, with no serious adverse events reported. The most common treatment-related adverse events (TRAEs) were instillation site pain and headache (5%-8%). Ocular adverse reactions included blurred vision (2%-5%). Most adverse events were mild, transient, and self-resolving. Among patients experiencing ocular TRAEs, 96.1% were mild and 3.9% were moderate.^1,4

Dosing and Administration

The recommended dosage of Qlosi is 1 drop in each eye once daily, or as needed, up to twice daily. The second drop can be administered after 2 to 3 hours for an effect up to 8 hours. If more than 1 topical ophthalmic medication is being used, patients should administer the medicines at least 5 minutes apart.⁴

For more information, visit https://qlosiecp.com.

References

1. 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
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 November 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. 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 November 7, 2025. https://www.orasis-pharma.com/orasis-pharmaceuticals-announces-novel-corrective-eyedrop-presbyopia-qlosi/
4. Package insert. Orasis Pharmaceuticals; 2025.
5. EYEQ formulation. Qlosi. Accessed November 7, 2025. https://qlosiecp.com/formulation
6. Cunningham D. Comparison of monocular and binocular near vision improvement in the NEAR-1 and NEAR-2 phase 3 clinical trials: CSF-1 (0.4% pilocarpine HCl) for the treatment for presbyopia. Poster presented at: American Academy of Optometry 2023 annual meeting; November 11-14, 2023; New Orleans, LA.