Aerie Pharmaceuticals Inc (NASDAQ:AERI) shares are rising nearly 17% in Wednesday’s trading session, after positive FDA briefing documents for Aerie’s glaucoma drug Rhopressa were released. The FDA posted the documents ahead of an advisory committee meeting on Friday, October 13, 2017.
At the meeting, the panel will address three questions: 1) Do the clinical trials support the efficacy of netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension; 2) Does the efficacy of netarsudil ophthalmic solution, demonstrated in the clinical trials, outweigh the safety risks identified for the drug product; and 3) Discuss any suggestions you have concerning the proposed draft labeling of the product. These questions appear general in nature, especially compared to other meetings held by the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) and don’t appear to dive into specific issues surrounding Rhopressa.
Cantor analyst Elemer Piros opined, “Based on the lack of surprises in the FDA’s briefing document and inclusion of a draft package insert, we believe Rhopressa is poised for a favorable AdCom and ultimate regulatory decision. The package insert highlighted no surprises and comprehensively addressed the occurrence of hyperemia and revised criteria to treat patients with an IOP<25mmHg. In addition, questions for the meeting include a discussion on the initial draft labeling. We remain encouraged going into the advisory committee meeting and by Rhopressa’s potential to become the first novel drug for glaucoma in 20 years.”
Piros reiterates an Overweight rating on Aerie shares, with a price target of $62, which represents a slight downside potential from current levels. (To watch Piros’ track record, click here)
AERI has one of the best ratings in the biotech sector. TipRanks reveals that AERI has a Strong Buy analyst consensus rating with 8 back-to-back buy ratings in the last three months. Meanwhile the average analyst price target of $71.13 suggests the stock still has upside potential of just over 10% from the current share price for the next 12 months.