piperidines and Glaucoma--Open-Angle

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.. Double-masked, randomized, and vehicle-controlled study.. 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 week in 50 patients with minimum IOP of 24 mm Hg at 8 AM, with a main outcome measure of mean diurnal IOP at day 8 compared to baseline (ClinicalTrials.govNCT02743780).. There was no difference in favor of MGV354 for IOP lowering; change from baseline to day 8 in mean diurnal IOP was -0.6 mm Hg for MGV354-treated patients and -1.1 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.. Overall, MGV354 0.1% demonstrated no statistically significant effect compared to vehicle in lowering IOP based on the study's main outcome measure. MGV354 produced ocular hyperemia consistent with its pharmacology.

Topics: Administration, Ophthalmic; Adolescent; Adult; Aged; Double-Blind Method; Enzyme Activators; Female; Glaucoma, Open-Angle; Guanylate Cyclase; Humans; Intraocular Pressure; Male; Maximum Tolerated Dose; Middle Aged; No-Observed-Adverse-Effect Level; Ocular Hypertension; Ophthalmic Solutions; Piperidines; Pyrazoles; Pyridines; Tonometry, Ocular; Treatment Outcome; Visual Acuity; Young Adult

Topics: Animals; Antihypertensive Agents; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Piperidines; Pyrazoles; Pyridines; Rabbits