Aerie Pharmaceuticals Inc (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today reported the successful results of its second Phase 3 trial for Rhopressa™, 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 trial achieved its primary efficacy endpoint demonstrating non-inferiority of Rhopressa™ compared to timolol, the most widely used comparator. Management will host a conference call and provide accompanying slides to discuss these results at 5:00 p.m. ET today.
Rhopressa™ Phase 3 Highlights for Rocket 2
- Rhopressa™, dosed both once-daily and twice-daily, achieved its primary efficacy endpoint demonstrating non-inferiority compared to twice-daily timolol. The primary efficacy endpoint evaluated subjects with pre-study baseline IOPs of above 20 to below 25 mmHg (millimeters of mercury).
- The Rocket 2 efficacy results for Rhopressa™ demonstrated a consistent level of IOP lowering across all baseline IOPs and throughout the 90-day efficacy period.
- The most common Rhopressa™ adverse event was hyperemia, or eye redness, which was reported as increased in 35 percent of patients and was scored as mild for 83 percent of patients in the Rhopressa™ once-daily arm of the trial. The adverse event profile for the Rhopressa™ once-daily arm was consistent with the results of Rocket 1.
- With these successful Rocket 2 results, and the successful performance of Rhopressa™ in Rocket 1 at baseline IOPs below 25 mmHg, Aerie expects to file its NDA for Rhopressa™ in mid-2016.
As expected, Rhopressa™ dosed twice-daily generated a higher incidence of adverse events and was slightly more efficacious than Rhopressa™ dosed once-daily.
“We are very impressed by these Rhopressa™ Phase 3 results from the Rocket 2 study. This product has demonstrated great promise with its novel mechanisms of action, including its ability to target the diseased tissue responsible for elevated IOP in glaucoma. The clear success demonstrated in this clinical trial, combined with the preclinical research to date on the disease-modification potential of Rhopressa™, represent key building blocks in driving Aerie toward becoming a major ophthalmic pharmaceutical company,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “We look forward to our Rocket 2 safety results expected at the end of 2015 or early 2016. Based on our previous discussions with the FDA, we expect to file our Rhopressa™ NDA in mid-2016.”
Richard A. Lewis, M.D., Aerie’s newly appointed Chief Medical Officer who is a glaucoma specialist in Sacramento, California, past President of the American Society of Cataract and Refractive Surgeons (ASCRS) and past President of the American Glaucoma Society (AGS), added, “Clinicians have been waiting for an IOP-lowering product that targets the diseased tissue. None of the treatments currently in the market have this unique function. The Rhopressa™ efficacy data we see in these Rocket 2 results point to a potential breakthrough for our glaucoma patients.”
Rhopressa™ is a novel triple-action eye drop that we believe, if approved, would become the only once-daily product available that specifically targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Preclinical results have demonstrated that Rhopressa™ also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, Rhopressa™ provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, Rhopressa™ is known to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have shown that Rhopressa™ may have disease-modifying properties, including an anti-fibrotic effect on the trabecular meshwork and the potential to increase perfusion of the trabecular meshwork. Preclinical research is also currently underway to evaluate the potential neuroprotective benefits of Rhopressa™.
There are four Phase 3 registration trials for Rhopressa™. “Rocket 2,” the efficacy results of which are reported in this press release, is a 12-month safety trial with a 90-day interim efficacy readout. Safety data for the 12-month period of the Rocket 2 trial is expected late 2015 or early 2016. “Rocket 1,” the results of which were initially reported in April 2015, was a 90-day efficacy trial that did not achieve its primary endpoint, but did achieve its pre-specified secondary endpoint. “Rocket 3” is a 12-month safety-only study in Canada which is currently in progress. A fourth Phase 3 trial, named “Rocket 4,” is expected to commence in late September 2015. Based on the successful results of Rocket 2, Aerie expects to submit a New Drug Application filing for Rhopressa™ in mid-2016. (Original Source)
In reaction to the news, Aerie Pharmaceuticals shares are up 39% in after-hours trading. AERI has a 1-year high of $35.89 and a 1-year low of $8.84. The stock’s 50-day moving average is $16.66 and its 200-day moving average is $19.74.
On the ratings front, Aerie Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on August 6, Brean Murray Carret analyst Difei Yang maintained a Buy rating on AERI, with a price target of $33, which represents a potential upside of 82.5% from where the stock is currently trading. Separately, on August 5, Cantor Fitzgerald’s Caroline Corner reiterated a Buy rating on the stock and has a price target of $30.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Difei Yang and Caroline Corner have a total average return of 10.6% and -15.2% respectively. Yang has a success rate of 51.6% and is ranked #431 out of 3759 analysts, while Corner has a success rate of 33.3% and is ranked #3618.
Aerie Pharmaceuticals Inc is a clinical-stage pharmaceutical company engaged in the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye.