The recent first global approval of netarsudil ophthalmic solution 0.02% has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

In December 2017 netarsudil (Rhopressa®), developed by Aerie Pharmaceuticals, received its first global approval in the US for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.[3] Interestingly, this approval was made two months in advance of the official scheduled Prescription Drug User Fee Act (PDUFA) goal date of 28th February 2018.[4]

Netarsudil is a Rho-associated protein kinase inhibitor, dispensed as a 0.02% solution to be given once daily as eye drops. It is believed to lower intraocular pressure by increasing aqueous humour outflow through the trabecular meshwork.[1]

Glaucoma is estimated to affect more than 3 million American citizens; most do not know they are affected. This is because there are very few symptoms to suggest the present of glaucoma, and yet it is the second leading cause of blindness globally.[5]

Richard A. Lewis, MD, chief medical officer, Aerie Pharmaceuticals, and practicing glaucoma specialist, commented that, “the clinical community has been waiting 21 years for a new category of eye drops to enhance medical therapy for their patients with glaucoma.” He went on to explain that netarsudil, a Rho-kinase inhibitor (AKA ROCK inhibitor) was “the first new FDA-approved class of drug…to treat elevated intraocular pressure since the mid-1990s.”[6]

This FDA approval was supported by data from the Rocket 1[7] and Rocket 2[8] trials: in each once- and twice daily netarsudil was compared with timolol.[9]


Image credit:  Daniil Avilov on Unsplash

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