@article {1328904,
	title = {A Randomized, Controlled Phase I/II Study to Evaluate the Safety and Efficacy of MGV354 for Ocular Hypertension or Glaucoma},
	journal = {Am J Ophthalmol},
	volume = {192},
	year = {2018},
	month = {2018 Aug},
	pages = {113-123},
	abstract = {PURPOSE: To assess the clinical safety, tolerability, and efficacy of topically administered MGV354, a soluble guanylate cyclase (sGC) activator, in patients with ocular hypertension (OH) or glaucoma. DESIGN: Double-masked, randomized, and vehicle-controlled study. METHODS: Parts 1 and 2 evaluated safety and tolerability to identify the maximum tolerated dose (MTD) of once-daily MGV354 in 32 healthy volunteers (Part 1) and 16 patients with OH or glaucoma (Part 2) at a single clinical site. Part 3 was a multisite trial that evaluated intraocular pressure (IOP)-lowering efficacy of the MTD administered nightly for 1\&nbsp;week in 50 patients with minimum IOP of 24\&nbsp;mm Hg at 8 AM, with a main outcome measure of mean diurnal IOP at day 8 compared to baseline (ClinicalTrials.govNCT02743780). RESULTS: There was no difference in favor of MGV354 for IOP lowering; change from baseline to day 8 in mean diurnal IOP was -0.6\&nbsp;mm Hg for MGV354-treated patients and -1.1\&nbsp;mm Hg for vehicle-treated patients in Part 3, with a confidence interval of -0.7 to 1.7. The most common adverse events reported after MGV354 administration were conjunctival and ocular hyperemia. CONCLUSIONS: Overall, MGV354 0.1\% demonstrated no statistically significant effect compared to vehicle in lowering IOP based on the study{\textquoteright}s main outcome measure. MGV354 produced ocular hyperemia consistent with its pharmacology.},
	issn = {1879-1891},
	doi = {10.1016/j.ajo.2018.05.015},
	author = {Stacy, Rebecca and Huttner, Kenneth and Watts, Jen and Peace, James and Wirta, David and Walters, Tom and Sall, Kenneth and Seaman, John and Ni, Xiao and Prasanna, Ganesh and Mogi, Muneto and Adams, Christopher and Yan, Jing-He and Wald, Michael and He, Yunsheng and Newton, Ronald and Kolega, Randall and Grosskreutz, Cynthia}
}
