Preeya Gupta, MD, looks forward to the day she can give her patients the chance to take a break from the perpetual hunt for their reading glasses or the daily routine of cleaning and inserting contact lenses.
That day isn’t far off.
QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4%, a prescription treatment for presbyopia that received FDA approval in October 2023, is expected to become commercially available later this year.
“What’s really exciting about this product is there is a patient interest and a patient demand for presbyopia correction that’s not surgical or dependent on contact lenses or reading glasses,” says Dr. Gupta, managing director of Triangle Eye Consultants in Raleigh, N.C. “Eyedrops are of course the next natural kind of treatment delivery.”
HOW IT WORKS
Developed by Orasis Pharmaceuticals, QLOSI is a preservative-free eyedrop formulated at the lowest effective concentration that constricts the pupils to modulate depth of focus, enhancing near vision while maintaining distance acuity. According to the company, this mechanism presents a noninvasive, easy-to-administer alternative for patients seeking a break from their reading glasses.
In the two pivotal Phase 3 clinical trials that led to FDA approval, NEAR-1 and NEAR-2, QLOSI (pronounced KLOH-see) consistently demonstrated high efficacy, safety and tolerability. Involving more than 600 subjects between them, 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 (DCNVA), and no loss of 1-line or more in distance visual acuity, according to the company.
The most common treatment-related adverse events (AEs), headache and instillation site pain, occurred in only 6.8% and 5.8% of participants, respectively. Only 1.3% reported moderate treatment-related AEs. All other AEs were mild.
RELIEF FROM READERS
“Reading glasses have been the standard of care for literally hundreds of years. While they’re effective, research shows us that … for many patients, readers are the first signs of aging and they’re looking to rely less upon them,” says Paul Smith, COO and president of Orasis. “What we set out to do was to come up with a solution that really meets them where they are.”
QLOSI’s administration protocol involves instillation of one drop in each eye that can be used daily, or as needed, up to twice per day, and its effects last up to 8 hours without impacting distance or night vision, according to the company. Many patients will appreciate that flexibility, predicts Nate Lighthizer, OD, an optometrist and faculty member at Northeastern State University, the Oklahoma College of Optometry in Tahlequah, Okla.
“I could see a patient saying, ‘I’ll put a drop in at 8 in the morning and then maybe another drop at noon to get me through my entire day without having to remember my reading glasses or put in contact lenses.’ Or even just once in the evening to go out for dinner for a few hours. I think it’s going to be a nice option,” says Dr. Lighthizer, who was not involved in the clinical trials for the drug.
EFFICACY WITH LOW AE RATES
QLOSI is not the first prescription eyedrop treatment for presbyopia. Allergan’s VUITY (pilocarpine HCl ophthalmic solution) 1.25% was approved by the FDA for mild-to-moderate presbyopia in 2021.
“[QLOSI’s concentration of pilocarpine] is three times lower than what’s available for presbyopia today and five times lower than the concentration at which pilocarpine was most commonly used for management of glaucoma for decades,” Mr. Smith says. “It’s been known for some 50 years that the severity and frequency of AEs are closely associated with the concentration of the drug,” he notes.
QLOSI’s AE profile “is generally lower in terms of frequency but also in severity, where the overwhelming majority of all side effects were mild transient and self-resolving.”
“As clinicians, we’re always trying to deliver on efficacy and minimize side effects, and the 0.4% concentration does seem to have a much better tolerability,” agrees Dr. Gupta, who also was not involved in the clinical trials. “I do think that the reduced percentage will likely have less potential side effects and lower risk of retinal tears.”
PATIENT PROFILE
The NEAR-1 and NEAR-2 studies evaluated and found statistically significant response to QLOSI among all subjects between the ages of 45 and 64 years with otherwise healthy eyes, Mr. Smith says. However, he adds, the company’s market research found stronger motivation to use the drops in the early-to-moderate presbyope demographic, those in their late 40s and early 50s.
“The 45- to 55-year-old working professionals seem to really distinguish themselves among the broader market as those who want to be empowered to manage their vision on their terms,” he says. “We really think they’re going to be highly motivated to consider an alternative like QLOSI.”
Dr. Lighthizer agrees, citing himself as an example. “I’m 42 years old, and I have never worn contact lenses in my life. I’ve never had to wear glasses. And whenever it inevitably hits that I can’t see up close as well anymore, I’m just not dealing with glasses and contact lenses, nor do I want to. Those early to moderate presbyopes are going to be the low hanging fruit, your ideal candidates.” OM
Disclosures: Dr. Lighthizer is a consultant for Orasis Pharmaceuticals.
Dr. Gupta is a consultant for Orasis Pharmaceuticals and AbbVie.
