FDA Approves Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia

FDA Approves Velsipity for Moderate-to-Severe Ulcerative Colitis in Adults
October 17, 2023
FDA Approves Maxigesic ® IV to be Marketed in the U.S. as Combogesic ® IV (acetaminophen and ibuprofen) for the Management of Pain
October 18, 2023
FDA Approves Velsipity for Moderate-to-Severe Ulcerative Colitis in Adults
October 17, 2023
FDA Approves Maxigesic ® IV to be Marketed in the U.S. as Combogesic ® IV (acetaminophen and ibuprofen) for the Management of Pain
October 18, 2023

October 18, 2023 -- Orasis Pharmaceuticals, , today announced that the U.S. Food and Drug Administration (FDA) has approved QlosiTM (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. Qlosi is expected to be commercially available in the U.S. 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 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 without impacting distance or night vision. Qlosi is a preservative-free formulation of pilocarpine, an established eye care therapeutic, designed to achieve an optimal balance between efficacy, safety, and comfort.

Read more…