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Aerie's glaucoma drug gets strong preliminary FDA opinion

Published on 12/10/17 at 10:29am

In a preliminary review of the drug, the FDA has judged that Aerie Pharmaceutical’s experimental glaucoma treatment Rhopressa (netarsudil) effectively reduces intraocular pressure when administered once a day. The drug is currently being assessed in the indication of open-angle glaucoma or ocular tension.

The positive review comes just two days before a meeting to decide whether the drug should be approved in the US market. Agency reviewers did however question the effectiveness of a twice-daily regimen of the rho kinase inhibitor in patients with the highest degree of eye pressure.

The news from the FDA proved a huge boon for Aerie, as its shares leapt 19% on the announcement.

Rhopressa was previously tested in the Rocket 1 study in 2015, where it failed to lower intraocular eye pressure compared to existing treatment timolol. In the Rocket 2 trial, where baseline intraocular pressure was restricted compared to the first study, both once-daily and twice-daily regimens proved effective.

Caused by damage to the optic nerve including increased eye pressure, glaucoma affects 2.7 million people in the US and is the second-leading cause of blindness worldwide. The number of those affected in the US is expected to grow to four million by 2030.

Matt Fellows

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