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Aerie reports $14.5 million net loss for quarter, advances Rhopressa study
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Notwithstanding a total adjusted net loss of $14.5 million in the first quarter of 2015 and failure of Rhopressa to meet its primary endpoint in clinical trial, Aerie Pharmaceuticals believes in the potential of its once-daily, triple-action, IOP-lowering eye drop.
In a company-sponsored conference call to report first quarter financial status and company intentions, chairman and CEO Vicente Anido Jr., PhD, discussed recently released results of the initial phase 3 Rocket 1 clinical trial for Rhopressa.
“In this study, Rocket 1, we have gained far more insight across the spectrum of attributes of this drug, and we believe the meaningful potential for both Rhopressa and Roclatan,” Anido said. Roclatan is a combination of the Rhopressa formulation with a prostaglandin.
Results of the Rocket 1 trial, reported during a conference call on April 23, showed that Rhopressa did not meet its primary endpoint of non-inferiority to timolol in patients with a baseline IOP below 27 mm Hg. Furthermore, Rhopressa showed non-inferiority compared with timolol in patients with baseline IOP below 26 mm Hg, Anido said.
The Rocket 1 trial included 370 glaucoma patients; 182 patients received Rhopressa once daily and 188 received timolol twice daily.
The recent analysis of Rocket 1 data showed that previous prostaglandin use enhanced the IOP-lowering effect of Rhopressa at 2 weeks and 6 weeks, Anido said.
“There appears to be a tremendous synergistic effect between our drug and prostaglandins. This is the first time where we’ve actually been able show that we have this unique synergistic effect with prostaglandins that is not present with timolol,” he said.
As the company moves forward with the Rocket 2 trial, company officials plan to meet with FDA officials to discuss changing the range for the primary endpoint to a baseline IOP of less than 24 mm Hg or less than 25 mm Hg, Anido said.
“Overall, as we look at Rocket 1 observations, we think that the right thing to do is focus on those patients who are either below 24 mm Hg or 25 mm Hg,” he said. “Clearly, we had some great efficacy results here, especially as they related to those patients who were on pre-study prostaglandins.”
Results of the Rocket 2 study, a similar study with a different dosing protocol, are expected to be released in the third quarter. Rocket 3, a trial looking at safety, is being conducted in Canada. Rocket 4, a phase 3 trial, is planned for launch in the third quarter, Anido said.
Operating expenses for the company totaled $19.6 million in the first quarter, about $10.7 million more than in the first quarter of 2014, partly attributable to ongoing development of Rhopressa and Roclatan, according to an Aerie press release. A phase 2 trial for Roclatan was completed in June 2014.
As of March 31, Aerie had cash, cash equivalents and investments totaling $179.3 million, and the company raised an additional $35 million in the first quarter, chief financial officer Richard Rubino said during the call.
Pending study results, Aerie expects to file a new drug application with the FDA by the end of 2016 for Rhopressa, Anido said. - by Matt Hasson
Perspective
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Jason Bacharach, MD
Rhopressa demonstrated unique characteristics in the recent Rocket 1 trial. This is potentially the first new class of agents to be available to practicing clinicians in more than 2 decades. As the first Rho-kinase molecule to be evaluated in a phase 3 pivotal trial, there was some disappointment in the overall treatment group not reaching statistical non-inferiority to timolol. But when the data are examined in detail, some exciting potential is demonstrated. For example, recent analysis demonstrated that previous prostaglandin use enhanced the IOP-lowering effect of Rhopressa at 2 weeks and 6 weeks. This supported a presentation at this year’s American Glaucoma Society meeting of phase 2 data of Roclatan’s effectiveness. Roclatan is a fixed combination of Rhopressa and latanoprost. It outperformed each of the individual components in IOP reduction. Both trials support synergy between Rhopressa and prostaglandins.
In addition, Rhopressa has demonstrated enhanced efficacy at lower baseline IOPs that is not typical of our current classes of medications. This may be very important clinically as a large portion of our patients present initially with IOPs at 24 mm Hg or below.
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