FDA approves low-dose pilocarpine hydrochloride 0.4% as a treatment for presbyopia

The FDA announced the approval of pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi; Orasis Pharmaceuticals) to treat presbyopia.

The FDA announced the approval of pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi; Orasis Pharmaceuticals) to treat presbyopia.

Orasis Pharmaceuitcals' Elad Kedar, CEO, and Paul Smith, president and COO, sat down with Optometry Times®' assistant managing editor Emily Kaiser to give a high-level overview of the latest approval.

Presbyopia is 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 US.

This drug is the company’s focus, ie, the development of a unique eye drop to improve near vision for people with presbyopia.

In February 2023, the US Food and Drug Administration (FDA) accepted for review the company’s New Drug Application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%).

Elad Kedar, CEO of Orasis Pharmaceuticals

Paul Smith, president and COO of Orasis Pharmaceuticals

Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals, commented on the company’s endeavor, “We are encouraged by the acceptance of our NDA filing as we progress towards our mission of reshaping vision possibilities for the millions of people in the US living with presbyopia, or blurry near-vision.”

The NDA was based on the safety and efficacy data from the phase 3 NEAR-1 and NEAR-2 clinical trials in which more than 600 patients participated. The 2 studies showed that the primary and key secondary endpoints were met on day 8 of treatment with Qlosi.

The investigators found that pilocarpine HCI 0.4% achieved significant 3-line or more gains in the distance-corrected near visual acuity (DCNVA), and there was no loss of 1-line or more in the distance visual acuity.

Qlosi works by improving the near visual acuity via pupil modulation, the company explained. This results in a “pinhole effect” and an increase in the depth of field, which increases the patient’s ability to focus on near objects.

These results were achieved with a minimal effective dose of pilocarpine hydrochloride at 0.4%, which is less than a third of the concentration of the commercially available treatment. With a proprietary vehicle, Qlosi is formulated preservative-free and provides for dosing flexibility with a comfort and safety profile that does not compromise distance or night vision.

The most common treatment-related adverse events reported were headache and instillation site pain; these occurred in 6.8% and 5.8% of participants, respectively. Of all the study patients, only 2.6% reported moderate treatment-related adverse events. All other adverse events were considered 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.

References

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/