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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FDA Bests Annual Novel Drug Approval Record With Four Oks In One Week
The agency's Dec. 21 approval of Giapreza became novel drug No. 46 of 2017, topping the 2015 mark of 45.
Aerie's Rhopressa Approved Early For Glaucoma, 2018 Launch Planned
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.
A Big Week For FDA’s Top Eye Drug Reviewer
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.