24.04.2015 01:21:42
|
Aerie Sinks As Eye Pressure Drug Fails Primary Endpoint
(RTTNews) - Aerie Pharmaceuticals Inc (AERI), a clinical-stage company focused on treatments for eye diseases, on Thursday said a latestage trial of its experimental eye pressure drug Rhopressa failed to meet its primary end point. Following the announcement Aerie shares sank 64 percent in after-hours trade on the Nasdaq.
Rhopressa is a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
The latestage trial compared once-daily Rhopressa with twice-daily timolol, an existing therapy. Results showed that Rhopressa did not meet its primary efficacy endpoint of demonstrating non-inferiority of IOP lowering for Rhopressa compared to timolol, based upon IOP measurements at the end of week 2, week 6 and day 90. The trial included 182 patients in the Rhopressa arm and 188 patients in the timolol arm.
Also, the trial showed a slight loss of efficacy in the week 6 and day 90 measurements. Across the Rhopressa study, 36 patients or about 20 percent showed signs of loss of efficacy.
The primary adverse event in the study was mild hyperemia, which was experienced by about 35 percent of the Rhopressa patients, the company said.
"We are obviously disappointed that we missed the primary endpoint for Rocket 1," said CEO Vicente Anido.
"We look forward to our Rocket 2 efficacy results expected in the third quarter and twelve month safety results expected by the end of 2015."
Anido said that Rocket 2 results are expected to inform the company's future strategies, including the potential need for an additional Rhopressa Phase 3 registration trial.
Pending successful results from the remaining Phase 3 registration trials and a potential additional Phase 3 registration trial for Rhopressa, the Company expects to submit a New Drug Application filing by the end of 2016.
The Irvine, California-based company said it is well prepared to commence the quadruple-action Roclatan Phase 3 trials later in 2015.
AERI closed Thursday at $35.39, up $0.97 or 2.82%, on a volume of 2.2 million shares on the Nasdaq. In after hours, the stock dropped $22.62 or 63.92% at $12.77.
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu Aerie Pharmaceuticals Incmehr Nachrichten
Keine Nachrichten verfügbar. |