New clinical research evaluating Orasis Pharmaceuticals’ QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% is supporting safety findings on the eye drop’s treatment of adult presbyopia.
The data was presented during the Hawaiian Eye and Retina 2026 meeting in Big Island, Hawaii, this week.
And to coincide with this data readout, Glance President Jaclyn Garlich, OD, FAAO, spoke with Mark T. Dunbar, OD, FAAO, director of Optometric Services at the Bascom Palmer Eye Institute.
New data? How exciting … but first, some background on this drop.
Granted FDA approval in October 2023, QLOSI launched to the U.S. commercial market in April 2025 as a prescription-based, preservative-free (PF), low-dose pilocarpine solution with flexible dosing (but more on that in a moment).
Most importantly, though: The eye drop is known for its unique EyeQ Formulation, which enables the solution to maintain an optimal pupil size of 2 to 3 mm for enhanced visual acuity (VA) by creating a “pinhole effect.”
And what does that effect do for a patient’s vision?
This increases the depth of focus (and their ability to focus on near objects) while also minimizing the risk for diffraction.
- See here for more details on this near-neutral pH solution, which is formulated with both hyaluronic acid (HA) and hydroxypropylmethylcellulose (HPCM) for ocular comfort.
Now circle back to that flexible dosing you mentioned.
We’ll first take a look at QLOSI’s prescribing information (PI), which indicates that one drop of QLOSI should be administered topically in each eye for improved near vision.
- Its efficacy: An onset within 20 minutes and may be expected to last up to 8 hours following the second application.
Where that "flexibility" comes into play: The drop instillation can be repeated 2 to 3 hours after the first drops for an extended effect and used on a daily or as-needed basis—but only up to twice a day.
- Compare this to higher-dose pilocarpine 1.25%—the first FDA-approved presbyopia drop—and its up-to-9-hour efficacy with twice-daily dosing.
Noted. So, which patients are ideal for this?
Primarily those with early-to-moderate presbyopia—largely around the ages of 46 to 64 as well as mild myopia ( -4.50 D to +2.00 D), emmetropia, pseudophakic (post-cataract surgery), and even post-refractive surgery patients.
As for who isn’t ideal for these drops: Those who have had peripheral retinal pathology, lattice degeneration, and highly myopic patients—“I would be reluctant to use any miotic on them,” Dr. Dunbar noted.
Expand on this—and hone in on its prescription status.
Dr. Dunbar added that, as a prescription-only drop, QLOSI’s U.S. commercial availability is limited to those patients who have undergone an eye exam from an ECP.
“Orasis has really directed the drop to its specialty pharmacy, BlinkRx, so a patient has to attest that they’ve had a comprehensive eye exam,” he said.
Why this matters: This exclusive status is intended to ensure the drop’s overall safety in being dosed among its target patients—as well as to lower the potential risk for any adverse events (such as retinal detachments … but more on that below).
Alrighty, now to its clinical data.
QLOSI has already undergone clinical evaluation in two phase 3 trials (NEAR-1 and NEAR-2) involving over 600 presbyopia patients.
See here for a rundown of those results (with clinical insights from Orasis executives) and the single-digit adverse events associated with use.
Among the key takeaways from these trials:
- No reports of retinal detachments (RDs)
- Why focus on this: Research has linked RD development to topical miotic use, particularly with higher doses.
- No elevated or disproportionate incidence of RD
And based on the first 10 months (since April 2025) of QLOSI’s commercial availability:
- No reports of RD cases
- No serious adverse events reported to the FDA
That RD component is critical, isn’t it?
Indeed, it is. So much so that it led investigators to question whether the concentration of pilocarpine really makes a difference, in the long run.
Alrighty, now let’s talk about this new clinical study.
Conducted at Bascom Palmer Eye Institute in Miami, Florida, the prospective, head-to-head, single-center trial had one primary goal: To analyze QLOSI’s effect on three key responses among presbyopia patients:
- Ciliary muscle response (thickness; CMT)
- Pupil diameter
- Lens thickness (LT)
Talk more about the overall objective.
Investigators sought to determine whether the drug concentration (particularly pilocarpine 0.4% versus 2%) impacted ciliary muscle contraction (CMT)—and would therefore induce a potential increased retinal risk (RDs, specifically).
How: By analyzing the CMT (via OCT) with each treatment.
Tell me about the participants involved in this.
A total of 10 presbyopia patients (aged 46 to 63; mean age, 51.5) were enrolled, with spherical equivalents ranging from –2.50 D to +2.00 D.
- The exclusion criteria: Prior ocular surgery or comorbidities.
And how was the study set up?
Participants were topically administered each of three formulations on successive visits, approximately one week apart:
- Balanced salt solution (BSS, control)
- Pilocarpine 0.4% (QLOSI)
- Pilocarpine 2%
The evaluation: Thousands of images were captured using two anterior segment optical coherence tomography (OCT) devices at two time points (baseline and 1 hour post-instillation) under accommodative stimuli of 0 D and 2.5 D.
Next: the resulting data.
Following this analysis, pilocarpine 0.4% (QLOSI) was found to:
- Significantly reduce pupil diameter when compared to the control (BSS, p < 0.05)
- Produce no significant changes in LT or ciliary muscle movement(CMT) relative to the control
Translation: QLOSI and BSS resulted in relatively evenly matched CMT at both near and far distances.
And how did this compare to pilocarpine 2%?
Interestingly, the higher pilocarpine concentration resulted in:
- A statistically significant change in CMT at near not observed in the QLOSI or control groups
- A residual lens accommodative effect also not observed for the other two dose groups
- A dose-dependent effect on pupil diameter
So, in a nutshell?
Dr. Dunbar offers a look at these findings—with a particular emphasis on what this means for the potential risk of RD development among users.
Can we get some numbers?
We’ll take a look at all three dose groups’ CMT effects versus treatment for both near and far vision.
How about for the pupil diameter treatment effect?
And regarding lens thickness treatment effect?
Our last batch of data:
So with all of this in mind, what was concluded?
To sum it all up: Florence Cabot, MD, assistant professor of Clinical Ophthalmology at Bascom Palmer and an investigator of the study, noted QLOSI’s performance as "comparable” from BSS (the control)—while pilocarpine 2% (the high-concentration miotic) showed ciliary muscle movement.
- As such: “These findings are very encouraging, supporting that pilocarpine 0.4% behaves in a concentration-dependent manner compared to a high-concentration miotic,” she added “The results reinforce that formulation truly matters and low-concentration options may be particularly meaningful for patients considering a presbyopia therapy.”
Take note: Dr. Cabot presented the study’s findings during Hawaiian Eye and Retina meeting on Friday, Jan. 23.
And lastly: How can ECPs and patients access QLOSI?
For ECPs: Click here for details on how to get started prescribing QLOSI.
And for eligible patients: The prescription-based drop can be purchased out-of-pocket or via funds in a Flexible Spending Account (FSA) or Health Savings Account (HSA) without insurance approval.
- BlinkRx, Orasis’s specialty pharmacy partner, offers the drop in single-use vials
See here for pricing options