Aerie Pharmaceuticals Inc (NASDAQ: AERI) stock surged over 16.7% on October 11th, 2017. FDA has posted a preliminary review on the company’s website on Wednesday, which states that AERI’s Rhopressa, used for the treatment for glaucoma, is effective in lowering eye pressure. The FDA has posted the documents ahead of an advisory committee meeting on Friday, October 13, 2017.
Moreover, 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 are general in nature, especially compared to other meetings held by the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) and do not appear to do deep into the specific issues surrounding Rhopressa.
Additionally, as per the Cantor analyst Elemer Piros, that based on the lack of surprises in the FDA’s briefing document and inclusion of a draft package insert, he believes that 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. Further, the questions for the meeting include a discussion on the initial draft labeling. The analyst is encouraged by going into the advisory committee meeting and by Rhopressa’s potential to become the first novel drug for glaucoma in 20 years. Piros has reiterated an Overweight rating on Aerie shares, with a price target of $62, which represents a slight downside potential from current levels.
Aerie Pharmaceuticals stock has risen 58.8% in the last one year (source: Google Finance).