Novartis Rescula First-Line Indication Would Require Timolol Equivalence
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Companies seeking a first-line indication for glaucoma drugs need to show that their agents have IOP (intraocular pressure) reduction levels equivalent or superior to those of the beta-blocker timolol, FDA said in review documents for Novartis Ophthalmics’ (formerly Ciba Vision’s) Rescula (unoprostone 0.15%).