FDA reviewers back efficacy of Aerie Pharmaceuticals' glaucoma drug Rhopressa; shares rise

In documents released Wednesday ahead of an FDA advisory panel meeting on October 13, agency staff concluded that Aerie Pharmaceuticals' experimental therapy Rhopressa (netarsudil) effectively reduces eye pressure. The company is seeking approval of the Rho kinase inhibitor for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Shares in the drugmaker jumped as much as 19 percent on the news.

Specifically, the FDA reviewers agreed that Rhopressa was effective in lowing intraocular pressure when administered once a day, although they questioned the efficacy of the twice-daily regimen in patients with the highest pressure. In previously unveiled results, the drug failed to significantly lower intraocular pressure versus timolol in the Rocket 1 trial, while both once-daily and twice-daily doses of the treatment were effective in the Rocket 2 study, in which the baseline intraocular pressure range was restricted compared to Rocket 1.

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Meanwhile, Aerie is also developing the investigational glaucoma treatment Roclatan, which combines Rhopressa with latanoprost. The drugmaker plans to submit Roclatan for FDA approval later this year or early next year. Analysts have forecast combined sales of about $900 million by 2023 for Rhopressa and Roclatan.

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