Aerie's Netarsudil Headed For Broad Indication With Only Subpopulation Efficacy
US FDA's Dermatologic and Ophthalmologic Drugs Advisory Committee votes in favor of efficacy of proposed glaucoma treatment, but several say only in patients with baseline intraocular pressure less than 25 mmHg.
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The agency's Dec. 21 approval of Giapreza became novel drug No. 46 of 2017, topping the 2015 mark of 45.
The first of Aerie's two glaucoma candidates, Rhopressa, was approved in the US and a submission for combination product Roclatan is expected next year. Rhopressa may have muted uptake in 2018, however, since it won't launch until the second quarter and half of its market is covered by Medicare Part D.
Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.