Aerie Pharmaceuticals (AERI), which is specialized in glaucoma treatments reported successful results of its second Phase 3 trial for Rhopressa™ — a novel once-daily, triple-action eye drops for glaucoma.
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: Dosed once-daily and twice-daily, Rhopressa™, 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).
Rhopressa™ Rocket 2 results demonstrate a consistent level of IOP lowering across all baseline IOPs and throughout the 90-day efficacy period.
Rhopressa™ adverse event: The most common was eye redness, which was reported as increased in 35 percent of patients. However, this hyperemia was 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.
The successful Rocket 2 results added to the successful results 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 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). He had something to add, stating, “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 mesh-work, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma.
Preclinical results demonstrated that Rhopressa™ also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects.
Moreover, Rhopressa™ provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP.
Biochemically, Rhopressa™ inhibits 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 mesh-work and the potential to increase perfusion of the trabecular mesh-work.
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.
“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.
“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.
Conference Call / Web Cast Information
Aerie management will host a live conference call and webcast at 5:00 p.m. Eastern Time today to discuss the Rhopressa™ Phase 3 efficacy results from Rocket 2.
The live webcast and a replay may be accessed by visiting Aerie’s website at http://investors.aeriepharma.com.
Key data slides from the Rhopressa™ Rocket 2 study will be discussed on the conference call and are posted to the website. Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 1-888-734-0328 (U.S.) or 1-678-894-3054 (international) to listen to the live conference call. The conference ID number for the live call is 42505859.
Please dial in approximately 10 minutes prior to the call. Telephone replay will be available approximately two hours after the call. To access the replay, please call 1-855-859-2056 (U.S.) or 1-404-537-3406 (international). The conference ID number for the replay is 42505859. The telephone replay will be available until September 22, 2015.
Aerie Pharmaceuticals is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye.
Aerie reported today the successful results of the Phase 3 registration trial in the United States named Rocket 2, where the primary efficacy endpoint was to demonstrate non-inferiority of IOP lowering for Rhopressa™ compared to timolol. Aerie recently completed its first Phase 3 registration trial, named Rocket 1, the three-month efficacy results of which were initially reported in April 2015, and expects to commence a fourth Phase 3 registration trial, named Rocket 4, in late September 2015.
Aerie also completed in 2014 a Phase 2b clinical trial in which Roclatan™ met the primary efficacy endpoint, demonstrating the statistical superiority of Roclatan™ to each of its components, and plans to commence the first Phase 3 registration trial for Roclatan™, named Mercury 1, in late September 2015.
Aerie also recently announced research collaborations with GrayBug, Inc. and Ramot at Tel Aviv University as it further builds it pipeline for future growth.
On Wednesday, February 11, 2015, we wrote an article under News & Comments about Aerie. Here is what we wrote:
Prohost Word, February 11, 2015
We are optimistic about AERIE’s drugs for glaucoma and we believe that the firm has done a great job developing the two products Rhopressa™ and Roclatan, which if approved (we believe they will be approved) the firm’s equally important task, i.e., to market these drugs by itself in the U.S. will begin. Indeed that’s what the firm intends to do in the United States, while bringing other marketers for other countries, including Japan and the European Union.
AERIE is trading on the NASDAQ under the symbol AERI. The stock is trading around$28 with a positive momentum that boosted it starting October-November 2013, taking it up slowly, but surely, from around $11 around year-end 2013 to its current price.
We are expecting efficacy results for Rocket 2 clinical results in mid 2015 and of Rocket 1 in the middle of second-quarter 2015. Filing for approval is expected in 2016. This is a good scientific study, regarding a successful development of far-reaching treatments for glaucoma.
We are optimistic, yet, we will be more comfortable learning more about the firm’s plans for the drugs’ marketing in the U.S. by itself. We decided to buy the minimum amount of stock at the current price prior to the clinical trial results. We will accumulate on weaknesses going forward towards the results, then the filing for approval and then the approval.
Aerie, we believe, is a candidate for acquisition by one of the big firms specialized in eye diseases, especially glaucoma.
Since February 11, market games, fluctuations and volatilities, yo-yoed the stock, bringing it down as if the end of the world has come to this firm.
We still believe that Aerie will have this promising glaucoma product on the market at the end of 2016.
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