FDA approves Qlosi eye drops for treatment of presbyopia

Key takeaways:

• The FDA has approved Qlosi for the treatment of presbyopia.
• The eye drops are expected to be available in the United States in the first half of 2024.

The FDA has 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 essential for us as we sought to provide a solution for presbyopes that truly balances effectiveness, 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 clinical trials NEAR-1 and NEAR-2, which studied the safety and effectiveness of the ophthalmic solution, involving more than 600 patients. Qlosi achieved a statistically significant gain of three or more lines in corrected near visual acuity distance, and the trials met their primary and secondary endpoints at day 8.

Elad Kedar

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 daily as needed, has been shown to be effective 20 minutes after administration and can last up to 8 hours, measured on day 15 to improve near vision, says the press release.

Paul Smith

“Now that Qlosi is FDA approved, we plan to begin scaling the organization for launch in the first half of 2024.” Paul Smith, president and chief operating officer of Orasis, told Healio. “We look forward to growing this category by providing a new option for those looking to reduce their reliance on readers.”

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