General Information

Qlosi (pilocarpine hydrochloride ophthalmic solution) is a cholinergic agonist.

Qlosi is specifically indicated for the treatment of presbyopia in adults.

Qlosi is supplied as a solution for ophthalmic administration. Instill one drop of Qlosi in 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.

Mechanism of Action

Qlosi (pilocarpine hydrochloride ophthalmic solution) is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. Qlosi contracts the iris sphincter muscle, constricting the pupil to enhance the depth of focus and improve near visual acuity while maintaining some pupillary response to light.

Side Effects

The most common adverse reactions associated with the use of Qlosi in clinical trials were instillation site pain and headaches.

Clinical Trial Results

The FDA approval of Qlosi was 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 Qlos. 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.