Netarsudil/latanoprost fixed-dose combination for elevated intraocular pressure: Three-month data from a randomized phase 3 trial
American Journal of Ophthalmology Dec 06, 2019
Asrani S, Robin AL, Serle JB, et al. - Researchers performed this three-month primary endpoint analysis of a randomized, double-masked, phase 3 clinical trial, to compare a fixed-dose combination (FDC) of the Rho kinase inhibitor netarsudil and latanoprost vs monotherapy with netarsudil or latanoprost, in terms of ocular hypotensive efficacy and safety. Randomization of adults with open-angle glaucoma or ocular hypertension (unmedicated intraocular pressure [IOP] > 20 and < 36 mm Hg at 8:00 AM) was done to once-daily netarsudil/latanoprost FDC, netarsudil 0.02%, or latanoprost 0.005% for up to 12 months. At week 2, week 6, and month 3, mean IOP was assessed at 8:00 AM, 10:00 AM, and 4:00 PM (primary efficacy endpoint). Across all 9 time points through month 3, the observed IOP reductions brought about by once-daily netarsudil/latanoprost FDC were found to be statistically and clinically superior to netarsudil and latanoprost and this FDC treatment regimen had acceptable ocular safety.
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