Deep Dive with QLOSI

Описание: Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, launched in April 2025, is a preservative-free, once- or twice-daily,
corrective eye drop for presbyopia—offering adults an additional option to help manage age-related blurry near vision.
Presbyopia affects more than 128 million people in the U.S. alone,1,2 and is traditionally managed with reading glasses or invasive
procedures like surgery. People living with this condition have long lacked a solution that aligns with how patients want to live:
independently, confidently and on their own terms.
Qlosi is uniquely formulated with our proprietary EyeQ™ Formulation, designed to achieve the balance between efficacy and
tolerability. At a near-neutral pH, Qlosi enhances bioavailability while minimizing side effects while helping to make it effective at a
minimum dose. The preservative-free formulation is delivered in single-use vials and includes lubricants (HA and HPMC) to support
ocular comfort. The thoughtful design allows patients to use Qlosi as it fits to their schedule, one drop per eye for specific activities or
up to twice daily for extended effect, lasting up to eight hours. It’s the first and only FDA-approved eye drop using the lowest effective
concentration of pilocarpine, offering a new option for adults seeking clear near vision.
Qlosi works through pupil modulation, creating a “pinhole effect” that increases depth of field. Achieving the right pupil size is essential
for improving near vision without compromising mean distance vision. Qlosi consistently maintained pupil size within the optimal range
across all study days, with the effect observed as early as 20 minutes post-dose. On Day 1, the mean pupil diameter in presbyopia
patients was 3.4 mm at 30 minutes post-dose (compared to 3.5 mm with vehicle). A pupil size of 2-3 mm – or roughly 30% reduction
from natural pupil size has been shown to provide the best balance of improved near vision acuity and preserved distance vision and
image quality under various lighting conditions.
The FDA’s approval of Qlosi was based on the results of the Phase 3 NEAR-1 and NEAR-2 clinical trials, which evaluated the efficacy,
safety and tolerability of Qlosi in more than 600 adult patients. 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 and no loss of 1-line or more in distance
visual acuity. In addition to demonstrating efficacy, the trials also confirmed a favorable safety profile, with the majority of adverse
events reported as mild and resolved quickly, with the most common including eye discomfort and headache (5% to 8% of users).
These outcomes validated the safety and efficacy of Qlosi and laid the groundwork for its successful market introduction.
Qlosi introduces a flexible, patient-friendly option to take a break from readers. It empowers patients to manage their vision on their
own terms and gives eye care professionals an option to offer patients that fit into their lives without compromising daily routines or
vision. This shift from passive correction to active management represents a fundamental evolution in how presbyopia is treated.