Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Aerie Pharmaceuticals (NASDAQ:AERI), a clinical-stage biopharmaceutical company focused on developing therapies to treat glaucoma and other diseases of the eye, galloped higher by much as 41% after reporting the results from its phase 2b trial utilizing once-daily roclatan as a treatment for glaucoma.
So what: According to Aerie's press release, roclatan, which is a combination of investigational triple-action compound rhopressa and latanoprost, a prostaglandin analogue best known by its brand-name Xalatan, met all of its clinical endpoints in its phase 2b study. Roclatan hit its primary endpoint, reducing mean diurnal intraocular pressures (IOP) from 25.1 millimeters of mercury (mmHg) at baseline on day 29 to 16.5 mmHg, a 34% reduction. Per the release, roclatan's diurnal IOP reduction was approximately 2 mmHg better than latanoprost by itself. Not only was roclatan more effective thatn latanoprost at day 29, but at each measurement interval throughout the trial it held an efficacy benefit over latanoprost. Overall, the therapy was well-tolerated with adverse events predominantly reported as mild along the 297 trial patients.
Aerie anticipates moving forward with phase 3 studies of roclatan with a new drug application filing expected about two years from now. It intends to manage sales in the U.S. (if approved) with its own sales staff but may choose to license out roclatan in overseas markets.
Now what: This is great news considering that latanoprost (Xalatan) is the most commonly prescribed glaucoma medication. If roclatan is already beating latanoprost at each step along the way we're looking at potentially better quality of life for patients and a possible blockbuster in the making. Of course, keep in mind that Aerie is still close to three years away from an approval based on its study and new drug application filing timeline, so investors have to understand that catalyst's like this are often few and far between. It might be tempting to chase Aerie higher on news similar to what we received today, but it's often not a wise move. I would absolutely suggest adding Aerie to your watchlist, but would stick to the sidelines until we have a sizable pullback before considering this as a long-term investment.
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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