FDA approves pilocarpine hydrochloride ophthalmic solution for treatment of presbyopia


Orasis Pharmaceuticals announces approval of Qlosi, a preservative-free, low-dose eye drop for presbyopia, which consistently demonstrated efficacy, safety, and tolerability in two pivotal Phase 3 trials.

(Image Credit: AdobeStock/Argus)

(Image Credit: AdobeStock/Argus)

Orasis Pharmaceuticals announced the FDA has approved pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi) for the treatment of presbyopia in adults.

The company announced it expects to have pilocarpine hydrochloride ophthalmic solution commercially available in the U.S. in the first half of 2024 for the treatment of presbyopia, the loss of ability to focus on near objects as a result of the natural aging process and affects more than 120 million people in the United States, usually after the age of 40

Elad Kedar, CEO of Orasis, noted the FDA approval of Qlosi marks a milestone for Orasis as the company continues its mission to provide a flexible treatment option for the millions of people in the United States living with presbyopia.

“I am grateful to the Orasis team, our strategic partners, clinical investigators, and patients who participated in our clinical trials, all of whom made this achievement possible,” Kedar said.

Kedar explained the Qlosi is a prescription eye drop that can be used daily, or as needed, up to twice per day. The solution demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision. Pilocarpine hydrochloride ophthalmic solution is a preservative-free formulation of pilocarpine, an established eye care therapeutic, designed to achieve an optimal balance between efficacy, safety, and comfort.

Kedar explained that pilocarpine hydrochloride ophthalmic solution 0.4% works on the iris sphincter muscle.

“It basically contracts that constricting the pupil creating what is called increasing depth of focus,” he said. “And this is what is correcting in your vision,” he said. “It can be repeated for a second time, after 2 or 3 hours, basically, to extend duration out to 8 hours.”

That flexibility is key to patients, according to Kedar.

“We know that different patients have varying needs for their near vision,” he said. “And that flexibility allows them to basically adapt utilization to their own needs and to their own varying needs every day.”

Paul Smith, president and chief operating officer at Orasis Pharmaceuticals, noted in an interview with Ophthalmology Times that presbyopia, for most people, tends to begin or at least its symptoms begin to appear around age 40, and it progresses over time.

“When you look at the 45 to 55-year-old presbyopes, that's where we see the highest level of interest and potentially the highest utility,” he said. “Now as far as patients, using a product that is a lot mentioned provides a mechanism for pupil modulation or pupil constriction. There are other indications beyond presbyopia, that could indeed benefit younger patients. As it relates to the current indication, we expect this to be used by patients at least 40 years old or older.”

Smith added the company is pleased to receive the approval, and the solution can “provide patients and eye care professionals, who are looking to reduce dependence on readers, a new option within this growing category.”

“This milestone is just the beginning as we start scaling the organization to support the launch of Qlosi in 1H 2024,” he added.

Peter McDonnell, director of the Wilmer Eye Institute at The Johns Hopkins University School of Medicine in Baltimore, Maryland, and co-chief medical editor of Ophthalmology Times, noted the drop is similar to pilocarpine HCI ophthalmic solution 1.25% (Vuity; Allergan), which was approved by the FDA in 2021.

“This new drop has a lower concentration of the active agent (pilocarpine) than does Vuity,” McDonnell said. “I think we will need to see how the two drops compare in head-to-head trials before we will understand what the differences may be in terms of efficacy and adverse events.”

Moreover, McDonnell said there will be plenty to learn with more than one option for presbyopia management with topical therapy.

Sheri Rowen, MD, FACS, FWCRS, PCEO, medical director NVision Eye Centers, Newport Beach, California, pointed out providers are eager to improve outcomes for their presbyopia patients, who often struggle with the inflexibility of current treatment options.

“Patients will be delighted to have the option to customize their use of low-dose pilocarpine for their personal visual needs,” Rowen said. “Based on the statistically significant efficacy and tolerability demonstrated in the two pivotal clinical trials with such a minimum effective dose, Qlosi’s results reinforce the important role of formulation in reimagining a new approach to treating these patients.”

The company noted the FDA approval is based on results from the Phase 3 NEAR-1 (NCT04599933) and NEAR-2 (NCT04599972) clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of pilocarpine hydrochloride ophthalmic solution. 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. The most common treatment-related adverse events of headache and instillation site pain occurred in only 6.8% and 5.8% of participants, respectively. Of all QLOSI participants, only 1.3% reported moderate treatment-related adverse events. All other adverse events were mild.

Richard Lindstrom, MD, founder and attending surgeon emeritus, Minnesota Eye Consultants, highlighted the importance the solution offers for presbyopia patients.

“Each presbyopia patient has different visual demands, yet all are impacted in the ability to perform day-to-day functions,” Lindstrom said in a statement. “It’s very exciting to see a novel, new treatment category emerging for this challenging patient population which will give eye care professionals more options throughout the presbyopic journey.”

Gina Wesley OD, MS, FAAO, Owner of Complete Eye Care of Medina, highlighted the impact the solution can have on patients in optometric offices.

“Optometrists, who deliver the majority of eye care exams, will play a critical role in the continued diagnosis and treatment plan for presbyopes,” Wesley said in a statement. “For new and existing patients that are looking for options beyond readers and contact lenses, I’m looking forward to being able to provide Qlosi as an additional option for patients to manage their presbyopia.”

Paul Karpecki, OD, FAAO, director, Cornea and External Disease, Kentucky Eye Institute, and associate professor, University of Pikeville, Kentucky College of Optometry, said the treatment can offer options to help patients manage their presbyopia in ways that work for them with fewer tradeoffs.

“In clinical trials, Qlosi demonstrated the optimal balance of efficacy, safety, and tolerability, and the FDA approval marks an exciting next step in being able to provide a new treatment for patients looking for a break from reading glasses or contact lenses,” he concluded.

  1. Orasis Pharmaceuticals announces FDA approval of Qlosi (Pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia. Orasis Pharmaceuticals. Press Release. Released October 18, 2023. Accessed October 18, 2023. https://www.orasis-pharma.com/orasis-pharmaceuticals-announces-fda-approval-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4-for-the-treatment-of-presbyopia/
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