FDA Approves Orasis Pharmaceuticals' Presbyopia Eye Drop Qlosi

Orasis Pharmaceuticals announced that the FDA has approved Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. Qlosi is expected to be commercially available in the US in the first half of 2024.

Qlosi is a prescription eye drop that can be used daily, or as needed, up to twice per day. Qlosi demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision. Qlosi is a preservative-free formulation of pilocarpine designed to achieve an optimal balance between efficacy, safety, and comfort. The drop is designed to improve near visual acuity by pupil modulation, resulting in a "pinhole effect" and an increase in the depth of field, thus increasing the ability to focus on near objects.

"We designed Qlosi with the patient in mind. We knew that we need to deliver a product with an optimal balance across efficacy, safety, and comfort," Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals, said in an interview with EyewireTV. "And one key area to get to that was to find the minimal effective dose, which we did throughout our rigorous phase 2 program. And our final dose is actually less than one-third of the concentration of the other prescription product indicated for presbyopia."

Orasis President and Chief Operating Officer Paul Smith told EyewireTV that Qlosi will be a cash pay product. He said the company will share the specific cost of the product and commercial terms as the company gets closer to launch.

To view the entire interview with Mr. Kedar and Mr. Smith, click here. 

The FDA approval is based on results from the phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of Qlosi. Both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of 1-line or more in distance visual acuity. The most common treatment-related adverse events of headache and instillation site pain occurred in 6.8% and 5.8% of participants, respectively. Of all Qlosi participants, 1.3% reported moderate treatment-related adverse events. All other adverse events were mild.

"With over 128 million presbyops in the US alone. If only 5%, for example, choose to participate, that market is still three times larger than the prescription dry eye market in the US, which we know generates massive interest and it represents a huge unmet need," Mr. Smith told EyewireTV. "So presbyopia is already a multiple of that. Now, when looking at who are the right patients to engage, we've seen, again, both clinically and from a market research perspective, that 40 to 55-year-old range really tend to be those who are most compelled to take action and seek a break from their readers."

For full prescribing information, visit www.Qlosi.com.