Aerie Climbs After FDA Briefing Concurs With Efficacy Claims

Source: FierceBiotech

Wednesday, October 11, 2017 | Glaucoma , Aerie Pharmaceuticals


Aerie Pharmaceuticals has received good news going into its FDA advisory committee meeting. The FDA agreed with the efficacy conclusion Aerie reached to support its bid for approval of glaucoma and ocular hypertension hopeful Rhopressa, according to a report in FierceBiotech.

A panel of experts convened by the FDA will take a deep dive into the data and opine on its merits on Friday. The meeting could still throw Aerie a curveball and dent the chances of approval for Rhopressa, which suffered setbacks in the clinic on its way to the FDA filing. But for now investors are celebrating clearing the first hurdle without suffering critical blows. 

In a briefing document put together to support the experts’ discussion, the FDA said it concurs with Aerie’s “overall efficacy conclusion that netarsudil 0.02% once-daily is efficacious for the reduction of elevated intraocular pressure (IOP).”

Read the full article.


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