The FDA has approved Vizz (Lenz Therapeutics), a 1.44% ophthalmic solution of the cholinergic agonist aceclidine, for treatment of presbyopia in adults. Aceclidine has been available in the EU for years for treatment of open-angle glaucoma.
PRESBYOPIA — Presbyopia is a common age-related condition characterized by gradual loss of clear near vision. It is thought to be caused by loss of lens elasticity and weakening of ciliary muscles.
STANDARD TREATMENT — Corrective lenses (glasses and contact lenses) are the first-line treatment for...
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RELEASE
The oral glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Rybelsus – Novo Nordisk), which was approved by the FDA in 2019 for treatment of type 2 diabetes in adults, has now also been approved to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who are at high risk for these events.1 The injectable GLP-1 receptor agonists semaglutide (Ozempic), dulaglutide (Trulicity), and liraglutide (Victoza) are also approved for cardiovascular risk reduction in patients with type 2 diabetes (see Table 1).2
CLINICAL STUDIES — FDA approval of oral semaglutide for the new indication was based on the results of a double-blind trial (SOUL) in 9650 patients ≥50 years old with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or both. Patients were randomized to receive oral …