Orasis Pharmaceuticals has officially launched the prescription-based QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of adult presbyopia in the United States.
This news comes nearly 6 months after the company secured $78 million in Series D financing to support the eye drop’s introduction to the U.S. commercial market—and 1.5 years after its FDA approval.
How exciting! Let’s start with a rundown on QLOSI.
What it is: A cholinergic receptor agonist with a preservative-free formulation of low-dose (0.4%) pilocarpine.
How it works: Dubbed the EyeQ Formulation, the solution maintains an optimal pupil size of 2 to 3 mm for enhanced visual acuity (VA) by creating a “pinhole effect.”
- What this does: Increases the depth of focus (and the ability to focus on near objects) while also minimizing the risk for diffraction.
So what makes the EyeQ Formulation unique?
Take a look at a few of its properties:
- A near-neutral pH solution to increase its bioavailability (for maximum effectiveness)
- Dual lubricating agents for ocular comfort
Gotcha. And its dosing schedule?
Flexibility is the key word for this, according to Orasis.
According to prescribing information (PI): One drop of QLOSI should be administered topically in each eye for improved near vision—with its efficacy lasting anywhere from 20 minutes to 8 hours following application.
Important to note: This 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.
- And if using more than one topical ophthalmic medication, the PI advises that each must be administered at least 5 minutes apart.
What potential safety concerns and precautions should be kept in mind?
Among the warnings listed in its PI:
- Blurred vision
- Plus: temporary dim or dark vision
- Retinal detachment risk (rare occurrence)
- Iritis (patients are advised against drop use when present, as adhesions may form)
- Contact lens wear
- Lenses must be removed prior to instilling drops and reinserted at a minimum of 10 minutes post-dosing
- Eye injury or contamination
- To prevent: Avoid touching the top of QLOSI’s single patient-use vial to the eye or any other surface
Moving on to adverse reactions and contraindications.
Just one contraindication is noted: hypersensitivity.
As for adverse reactions, the most common treatment-related occurrences were instillation site pain and headaches—which developed in 5.8% to 6.8% of patients in clinical trials, respectively, and were reported to be “mild, transient, and self-resolving.”
- Looking specifically at ocular adverse reactions, 2% to 5% of patients reported blurred vision.
Speaking of clinical trials—how did QLOSI perform?
In two phase 3 studies (NEAR-1 and -2) conducted among 600+ presbyopia patients: Both met their primary and secondary endpoints by Day 8, achieving a statistically significant 3-line+ gain in distance-corrected near VA and no loss of 1-line+ in distance VA.
- Check out further insights on these—including feedback from Orasis CEO Elad Kedar.
And the overarching significance of this drop?
A major win: QLOSI is the second eye drop ever approved by the FDA indicated for the treatment of presbyopia among adults—and, as marketed: “the only FDA-approved eye drop with the lowest effective concentration of pilocarpine.”
- Its target patients: Patients with early-to-moderate presbyopia as well as those with mild myopia or emmetropia.
Nice! So where is this available for purchase?
In general: The drop can be purchased out-of-pocket or through Flexible Spending Account (FSA) or Health Savings Account (HSA) funds without insurance approval.
- Prescriptions of single-use vials can be issued through two pharmacy partners (with free home delivery in two to five days):
- BlinkRx
- Medvantx
For ECPs: Eyecare professionals can click here to learn about how to get started prescribing QLOSI to their qualifying patients (and see here for potential pricing options).
Patients receiving their first prescription will be provided with a QLOSI Clear Starter Kit that includes guidance on using the eye drop for the first 7 days and in the long term.