FDA panel recommends Aerie's glaucoma drug Rhopressa for approval

Aerie Pharmaceuticals said Friday that an FDA advisory committee voted unanimously that clinical data show Rhopressa (netarsudil) reduces elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The panel also voted 9-1 that the experimental Rho kinase inhibitor's efficacy outweighs its safety risks. The backing follows a recent FDA staff report, which had concluded that Rhopressa effectively reduces eye pressure. 

Advisory panel member Young Kwon suggested Rhopressa represents "a major advance in glaucoma therapy." Meanwhile, Aerie CEO Vicente Anido remarked "we are delighted with the outcome of the FDA's advisory committee," adding that "we believe there are significant unmet needs in the treatment of patients with open-angle glaucoma or ocular hypertension, and we are very excited about the prospects for Rhopressa." The agency is expected to issue a final decision regarding whether to approve the drug by February 28, 2018. 

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Aerie noted that its marketing application included data from the Phase III Rocket 1 and Rocket 2 trials. In the Rocket 1 study, Rhopressa had failed to demonstrate non-inferiority of IOP lowering when dosed once daily, versus twice-daily timolol. However, in the Rocket 2 trial, which was modified to include patients with a more restricted baseline IOP range than in Rocket 1, both once-daily and twice-daily Rhopressa met the main goal of non-inferiority compared to twice-daily timolol. 

For related analysis, see ViewPoints: Aerie's ready to ROCKET on some friendlier-than-expected FDA documents.

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