FDA Approves Pilocarpine Hydrochloride Ophthalmic Solution to Treat Presbyopia

Pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi, Orasis Pharmaceuticals) has received FDA approval for the treatment of presbyopia in adults.

Presbyopia is the loss of the ability to focus on nearby objects and is caused by the natural aging process. A press release from Orasis states that 128 million people in the United States are affected by this disease. Presbyopia is reported to occur after the age of 40, leading to blurred daily vision. The disease cannot be prevented or reversed, and other available treatment options could be invasive.

Pilocarpine hydrochloride ophthalmic solution is a low-dose, preservative-free, prescription eye drop. The formula achieved the results of effectiveness, safety and comfort.

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

“The FDA approval of Qlosi marks an important milestone for Orasis as we continue our mission to provide a flexible treatment option to the millions of people in the United States living with presbyopia or blurred near vision,” Elad Kedar , CEO of Orasis Pharmaceuticals. said, in a press release. “I am grateful to the Orasis team, our strategic partners, clinical researchers and patients who participated in our clinical trials, all of whom made this achievement possible.

The approval was based on results from the NEAR-1 and NEAR-2 phase 3 clinical trials. The press release states that researchers included 600 people and evaluated the effectiveness and safety of pilocarpine hydrochloride ophthalmic solution. Primary and secondary endpoints were met.

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

Sheri Rowen, MD, FACS, FWCRS, PCEO, medical director of NVision Eye Centers, said in a press release that the promising results and approval have generated excitement among providers seeking to support their patients with presbyopia.

“Patients will be pleased to have the ability to personalize their use of low-dose pilocarpine based on their personal vision needs. Based on the statistically significant efficacy and tolerability demonstrated in the 2 pivotal clinical trials with such a minimum effective dose, the QLOSI results reinforce the hypothesis important role of the formulation in reinventing a new approach to the treatment of these patients ” Rowen said in a press release.

Reference

Orasis Pharmaceuticals announces FDA approval of QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia. Cision. Press 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.