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 12-month interim safety results of Rocket 2, Aerie’s second Phase 3 registration trial for RhopressaTM (netarsudil ophthalmic solution) 0.02%, a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The Company previously reported that Rocket 2 had achieved its primary 90-day efficacy endpoint of demonstrating non-inferiority of IOP lowering for RhopressaTM QD compared to timolol BID. The Rocket 2 trial is a pivotal trial expected to be part of Aerie’s NDA filing for RhopressaTM, which we expect to submit to the FDA in the third quarter of 2016. Management will host a conference call and provide accompanying slides to discuss these results at 5:00 p.m. ET today.
RhopressaTM QD Safety and Efficacy Highlights for Rocket 2
- The first 118 patients on RhopressaTM QD for the 12-month period demonstrated safety results consistent with those observed for the 90 day efficacy period. There were no new adverse events that developed over the 12-month period, and there were no drug-related serious adverse events.
- As expected, the most common adverse event was conjunctival hyperemia, or eye redness. Increased hyperemia over baseline was observed by biomicroscopy at a rate of 30 percent, of which 76 percent was considered mild. Hyperemia was sporadic; 70 percent of patients with prior conjunctival hyperemia had no hyperemia at month 12.
- The other adverse events observed during the twelve-month trial are consistent with those observed during the initial 90-day efficacy period. They included conjunctival hemorrhages, corneal deposits, and blurry vision, ranging from 5 percent to 23 percent of the 118 patients.
- Rocket 2 included IOP measurements at 8 am only at months six, nine and 12, in addition to the diurnal measurements taken during the initial 90-day efficacy period. For the first 118 patients who reached the 12-month mark, RhopressaTM QD demonstrated a consistent level of IOP lowering at 8 am from day 90 through month 12, with a nominal variance of only 0.1 mmHg between day 90 and month 12.
“We are very pleased to see that RhopressaTM QD continues to demonstrate a positive safety profile and, very importantly, consistent IOP lowering throughout the 12-month period. Our NDA filing remains on track for the third quarter of 2016,” saidVicente Anido, Jr., Ph.D., Chief Executive Officer and Chairman at Aerie.
Dr. Anido continued, “In addition to proceeding with our RhopressaTM NDA filing, we also look forward to our first Phase 3 90-day efficacy readout for RoclatanTM, also expected in the third quarter of 2016. On a separate note, we are reporting that our preliminary cash burn for full-year 2015 is consistent with our earlier guidance of approximately $60 million, and our year-end 2015 cash, marketable securities and investments amounted to approximately $150 million. We remain well-financed for 2016.”
Richard A. Lewis, M.D., Aerie’s Chief Medical Officer, and glaucoma specialist, stated, “We expect that clinicians will be highly satisfied with the long-term safety and efficacy results demonstrated in our clinical trials. They have waited for a generation for a product with the novel qualities of RhopressaTM.”
RhopressaTM (netarsudil ophthalmic solution) 0.02% is a novel 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 RhopressaTM also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, RhopressaTM provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, RhopressaTM is known to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have shown that RhopressaTM 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 RhopressaTM. The representations above regarding the RhopressaTM mechanisms of action are the result of Aerie’s preclinical studies and clinical trials.
There are two Phase 3 registration trials (Rocket 2 and Rocket 1) for RhopressaTM required for NDA filing. Rocket 2 will be the pivotal trial and Rocket 1 will be supportive for the NDA filing that we expect to submit to the FDA in the third quarter of 2016. Rocket 2, the interim safety results of which are reported in this press release, is a 12-month trial which previously achieved its 90-day primary efficacy endpoint. For Rocket 2, the 90-day efficacy period included IOP measurements at week two, week six and day 90 at 8 am, 10 am and 4 pm. Thereafter, safety observations and IOP measurements were conducted at 8 am only at the end of months six, nine and twelve. 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 but not needed for NDA filing. A fourth Phase 3 trial, Rocket 4, commenced in late September 2015, and is designed to provide adequate six-month safety data to meet regulatory filing requirements inEurope, and is also not required for the NDA filing in the U.S. (Original Source)
Shares of Aerie Pharmaceuticals jumped nearly 16% 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 $18.12 and its 200-day moving average is $20.39.
On the ratings front, Aerie has been the subject of a number of recent research reports. In a report issued on January 7, Brean Murray Carret analyst Difei Yang reiterated a Buy rating on AERI, with a price target of $48, which implies an upside of 238.5% from current levels. Separately, on December 1, Cantor Fitzgerald’s Caroline Corner reiterated a Buy rating on the stock and has a price target of $40.
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 -22.0% and -26.5% respectively. Yang has a success rate of 17.5% and is ranked #3589 out of 3610 analysts, while Corner has a success rate of 25.6% and is ranked #3537.
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.