Qlosi
Generic: PILOCARPINE HYDROCHLORIDE
Basic Information
Manufacturer
Orasis Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
4ee2a840-1203-473a-aa42-316a3ddf2fbe
Indications & Usage
1 INDICATIONS AND USAGE QLOSI is indicated for the treatment of presbyopia in adults.
QLOSI is a cholinergic agonist indicated for the treatment of presbyopia in adults.
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QLOSI is a cholinergic agonist indicated for the treatment of presbyopia in adults.
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Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (5% to 8%) are instillation site pain and headaches.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Orasis Pharmaceuticals Inc.
at 1-866-ORASIS1 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
QLOSI was evaluated in 309 patients with presbyopia in two randomized, double-masked, vehicle-controlled studies (NEAR-1 and NEAR-2) of 15 days duration.
The most commonly reported treatment-related adverse events in 5-8% of patients were instillation site pain, and headache.
Ocular adverse reaction reported in 2-5% of patients was blurred vision.
The majority of the adverse events were mild, transient and self-resolving.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Orasis Pharmaceuticals Inc.
at 1-866-ORASIS1 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
QLOSI was evaluated in 309 patients with presbyopia in two randomized, double-masked, vehicle-controlled studies (NEAR-1 and NEAR-2) of 15 days duration.
The most commonly reported treatment-related adverse events in 5-8% of patients were instillation site pain, and headache.
Ocular adverse reaction reported in 2-5% of patients was blurred vision.
The majority of the adverse events were mild, transient and self-resolving.