Qlosi FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 18, 2023.
FDA Approved: Yes (First approved October 17, 2023)
Brand name: Qlosi
Generic name: pilocarpine hydrochloride
Dosage form: Ophthalmic Solution
Previous Name: CSF-1
Company: Orasis Pharmaceuticals
Treatment for: Presbyopia
Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4%, is a low dose formulation of the approved cholinergic agonist pilocarpine indicated for the treatment of presbyopia in adults.
- Presbyopia is the loss of ability to focus on near objects as a result of the natural aging process. It is caused when the lens of the eye can't change shape to focus light correctly on the retina.
- Qlosi works 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.
- FDA approval was based on the results of the Phase 3 NEAR-1 and NEAR-2 clinical trials 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. 1.3% of patients reported moderate treatment-related adverse events and all other reported adverse events were mild.
- Pilocarpine hydrochloride is approved in multiple ophthalmic formulations and has been used in the treatment of chronic open-angle glaucoma and acute angle-closure glaucoma for decades. Pilocarpine hydrochloride was first approved under the brand name Vuity for the treatment of presbyopia in 2021.
- Qlosi is administered by instilling one drop into each eye. This can be repeated a second time after 2 to 3 hours for an effect up to 8 hours. Qlosi can be administered on a daily basis, or as needed, up to twice each day.
- Warnings and precautions associated with Qlosi include blurred vision and risk of retinal detachment.
- Common adverse reactions include instillation site pain and headaches.
Development timeline for Qlosi
Further information
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