Netarsudil, if approved, would become “the only once-daily product available that, based on Aerie’s preclinical and clinical studies, specifically targets the trabecular meshwork,” the company has stated in press releases. “Preclinical and clinical studies have also demonstrated that [netarsudil] lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, based on Aerie’s preclinical studies, [the product] may provide an additional mechanism that reduces fluid production in the eye and therefore lowers IOP.”
Aerie had said it will initiate phase I and II studies in Japan by year-end, and the FDA has now assigned a PDUFA date of Feb. 28, 2018 to rule on netarsudil for glaucoma and ocular hypertension.
Netarsudil also is being investigated in combination with latanoprost in the Mercury clinical studies.
1. Sit AJ, Kazemi A, McLaren JW, Kopczynski C, Heah TG, Novack GD. The effects of netarsudil ophthalmic solution on aqueous humor dynamics in humans. Poster presented at: ARVO 2017: Baltimore, MD: May 7, 2017. Abstract AO173.
2. Goel M, Picciani RG, Lee RK, Bhattacharya SK. Aqueous humor dynamics: A review. Open Ophthalmol J. 2010;4:52-59.