FDA approves Qlosi eye drop for treatment of presbyopia
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Key takeaways:
- The FDA approved Qlosi for the treatment of presbyopia.
- The eye drop is expected to be available in the U.S. in the first half of 2024.
The FDA approved Qlosi, a low-dose, preservative-free eye drop for the treatment of presbyopia in adults, according to a press release from Orasis Pharmaceuticals.
“We are delighted that Qlosi is now FDA approved,” Elad Kedar, CEO of Orasis, told Healio. “Identifying the minimum effective dose was critical for us as we sought to bring a presbyopic solution which truly balances efficacy, safety and comfort — designed with the patient in mind.”
Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4%, formerly known as CSF-1, was evaluated in the phase 3 NEAR-1 and NEAR-2 clinical trials, which investigated the safety and efficacy of the ophthalmic solution, involving more than 600 patients. Qlosi achieved a statistically significant three line or more gain in distance corrected near visual acuity, and the trials achieved their primary and key secondary endpoints by day 8.
Adverse events were mild overall, with the most common treatment-related adverse events being headache (6.8%) and instillation site pain (5.8%); 1.3% of participants reported moderate treatment-related adverse events.
Qlosi, which can be used daily or up to twice a day as needed, demonstrated efficacy 20 minutes after administration and can last up to 8 hours as measured on day 15 to improve near vision, the release said.
“Now that Qlosi is FDA approved, our plan it to start scaling the organization for a launch in the first half of 2024,” Paul Smith, president and chief operating officer of Orasis, told Healio. “We are eager to grow this category by providing a novel, new option for those seeking to reduce dependence on readers.”
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