FDA Approves Pilocarpine Hydrochloride Ophthalmic Solution to Treat Presbyopia

Pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi, Orasis Pharmaceuticals) has been granted FDA approval for the treatment of presbyopia in adult individuals.

Presbyopia is the loss of ability to focus on nearby objects and is caused by the natural aging process. A press release from Orasis noted that 128 million individuals in the US are impacted by the condition. Presbyopia is reported to occur in individuals after the age of 40, resulting in blurred daily vision. The condition cannot be prevented or reversed, and other available treatment options could be invasive.

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Pilocarpine hydrochloride ophthalmic solution is a prescription, preservative-free, low-dose eye drop. The formula has met efficacy, safety, and comfort outcomes.

The drop should be administrated daily or twice daily as needed and provides relief within 20 minutes. The effects were reported to last up to 8 hours and improve near vision for individuals by day 15 of treatment without impacting distance or night vision. The role of pilocarpine is to improve the near visual acuity by pupil modulation, leading to an increased ability to focus on nearby objects.

"The FDA approval of Qlosi marks a tremendous milestone for Orasis as we continue our mission to provide a flexible treatment option for the millions of people in the US living with presbyopia, or blurry near vision," Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals said, in a press release. "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."

The approval was based on results from the phase 3 NEAR-1 and NEAR-2 clinical trials. The press release noted that researchers included 600 individuals and assessed the efficacy and safety of pilocarpine hydrochloride ophthalmic solution. The primary and secondary endpoints were met.

The researchers noted that the most common treatment-related adverse events from the trial included headache and site pain in 6.8% and 5.8% of individuals, respectively. Other events were mild.

Sheri Rowen, MD, FACS, FWCRS, PCEO, Medical Director at NVision Eye Centers, said in a press release that the promising results and approval created excitement among providers looking to support their patients with presbyopia.

"Patients will be delighted to have the option to customize their use of low-dose pilocarpine for their personal visual needs. Based on the statistically significant efficacy and tolerability demonstrated in the 2 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," said Rowen, in a press release.

Reference

Orasis Pharmaceuticals Announces FDA Approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia. Cision. News release. October 18, 2023. Accessed October 18, 2023. https://www.prnewswire.com/news-releases/orasis-pharmaceuticals-announces-fda-approval-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4-for-the-treatment-of-presbyopia-301959581.html?tc=eml_cleartime.