Back to top

Image: Bigstock

Aerie Reports Positive Data on Ophthalmic Drug Rhopressa

Read MoreHide Full Article

Aerie Pharmaceuticals, Inc. reported encouraging six-month top-line safety and efficacy results from the phase III trial, ROCKET 4, on lead product candidate Rhopressa.

We note that Aerie is evaluating Rhopressa, a novel once-daily eye drop for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

The trial is being conducted to provide six-month safety data adequate for regulatory filing in Europe. The safety data observed over the six months were consistent with observations in previous three-month and 12-month phase III clinical trials.

The two-arm six month trial enrolled approximately 700 patients. The 90-day efficacy readout evaluating once-daily Rhopressa for non-inferiority to twice-daily timolol showed successful achievement of the 90-day primary efficacy endpoint. This data was released in Oct 2016. The most common adverse event was hyperemia, or eye redness which was reported in approximately 48% of patients, 75% of which was mild.

The data from the trial also showed that Rhopressa’s performance at months four, five and six remained within the non-inferiority range compared to timolol at each of the IOP measurement time points, including 8 a.m., 10 a.m., and 4 p.m. at baseline IOPs ranging from above 20 mmHg (millimeters of mercury) to below 25 mmHg, and also from above 20 mmHg to below 27 mmHg.

The data will be submitted to regulatory bodies in Europe in the second half of 2018.

We remind investors that the data from the trial was not necessary for the NDA submission in the U.S, but was included when the NDA was submitted in Feb 2017 as supportive data. 

We note that Aerie outperformed the Zacks classified Medical Drugs industry in the last six months. In fact, the stock gained 14.1% during this period, compared with a loss of 2.8 % for the industry.

Apart from Rhopressa, Aerie is evaluating Roclatan, a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer’s (PFE - Free Report) Xalatan. The company expects top line 90-day efficacy and safety data from the second phase III clinical trial, Mercury 2, for Roclatan 0.02%/0.005%, in second-quarter 2017. Data from Mercury 1 is expected in third-quarter 2017. If Mercury 1 and Mercury 2 are successful, the NDA for Roclatan is expected to be filed in late 2017 or early 2018. The company also expects to commence a trial, Mercury 3, in Europe to support filings there. The trial will be a non-inferiority trial comparing Roclatan to prescribed fixed dose combination that is Ganfort (a combination of the bimatoprost along with timolol), marketed by Allergan in Europe.

However, competition is stiff in the glaucoma market. Last month, Valeant Pharmaceutical’s New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024% was given a PDUFA date of Aug 24 by the FDA. Latanoprostene bunod is an IOP lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

Zacks Rank & Key Pick

Aerie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Best & Worst of Zacks

Today you are invited to download the full, up-to-the-minute list of 220 Zacks Rank #1 "Strong Buys" free of charge. From 1988 through 2015 this list has averaged a stellar gain of +25% per year. Plus, you may download 220 Zacks Rank #5 "Strong Sells." Even though this list holds many stocks that seem to be solid, it has historically performed 6X worse than the market. See these critical buys and sells free >>


See More Zacks Research for These Tickers


Normally $25 each - click below to receive one report FREE:


Pfizer Inc. (PFE) - free report >>