Aerie Pharmaceuticals Reports Positive Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 Topline Efficacy Results
IRVINE, Calif.--(BUSINESS WIRE) May 24, 2017 -- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), 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, today reported the successful primary efficacy results of the Company's 90-day Phase 3 "Mercury 2" registration trial for its fixed-dose combination product candidate, Roclatan™. The results of Mercury 2 were consistent with the successful 90-day efficacy results from the Mercury 1 trial, a 12-month Phase 3 registration trial for Roclatan™, which reported topline efficacy findings in September 2016. Mercury 2 achieved its primary efficacy endpoint of demonstrating statistical superiority over each of its components, including Aerie product candidate Rhopressa™ (netarsudil ophthalmic solution) 0.02%, and market-leading prostaglandin analogue (PGA) latanoprost, all of which were dosed once daily in the evening. The IOP-lowering effect of Roclatan™ was 1 to 3 mmHg (millimeters of mercury) greater than monotherapy with either latanoprost or Rhopressa™ throughout the duration of the study. The study evaluated patients with maximum baseline intraocular pressures (IOPs) ranging from above 20 to below 36 mmHg. Management will host a conference call with accompanying slides to discuss these results at 5:00 p.m. Eastern Time (ET) today. The accompanying slides are available at Aerie's website, aeriepharma.com.
Roclatan™ Phase 3 Highlights for Mercury 2
- Roclatan™ dosed once daily achieved the primary efficacy endpoint of demonstrating statistical superiority over both latanoprost and Rhopressa™ at the primary endpoint range of baseline IOPs from above 20 to below 36 mmHg for each of the nine measured time points.
- IOPs were measured at 8 a.m., 10 a.m., and 4 p.m. at week 2, week 6, and day 90. Roclatan™ IOP lowering exceeded that of latanoprost in a range of 1.5 to 2.4 mmHg for an average of 1.8 mmHg, and exceeded Rhopressa™ IOP lowering in a range of 2.2 to 3.3 mmHg for an average of 2.7 mmHg. Efficacy levels were consistent across the 90-day period for all arms in the study.
- Roclatan™ reduced mean diurnal IOPs to 16 mmHg or lower in 56 percent of patients, a significantly higher percentage than observed in the two comparator arms.
- Discontinuation rates for the 90-day period for Roclatan™ and Rhopressa™ were approximately 10 percent for each product candidate, representing the lowest discontinuation rates experienced across all Phase 3 trials of Roclatan™ and Rhopressa™.
- The most common Roclatan™ adverse event was hyperemia, or eye redness, which was reported in nearly 55 percent of patients, was sporadic, and was scored as mild for the large majority of these patients, generally consistent with previous trials. There were no drug-related serious or systemic adverse events for any of the treatment groups.
Dr. Anido continued, "In addition to the excellent efficacy observed in Mercury 2 for both Roclatan™ and Rhopressa™, we were also delighted to see relatively low discontinuation rates for the 90-day Mercury 2 trial of 9.8 percent and 10.6 percent for Roclatan™ and Rhopressa™, respectively."
Richard A. Lewis, M.D., Aerie's Chief Medical Officer, added, "Roclatan™ is distinguished by its ability to lower intraocular pressure to levels previously unseen with current glaucoma therapies, including market-leading latanoprost. This product holds the promise of potentially becoming the first prostaglandin fixed-dose combination available in the United States. The safety profile of Roclatan™ observed in Mercury 2 once again points to a safe and tolerable product."
Roclatan™ is a once-daily eye drop that combines Rhopressa™, as described below, with latanoprost, a widely prescribed PGA. Based on the Company's preclinical studies and clinical trials to date, Aerie believes that Roclatan™, if approved, would be the first glaucoma product to lower IOP through all known mechanisms: (i) increasing fluid outflow through the trabecular meshwork, the eye's primary drain, (ii) increasing fluid outflow through the uveoscleral pathway, the eye's secondary drain, (iii) reducing fluid production in the eye, and (iv) reducing episcleral venous pressure (EVP). By covering the full spectrum of known IOP-lowering mechanisms, Roclatan™ has the potential to provide a greater IOP-lowering effect than any currently approved glaucoma product.
The first Phase 3 registration trial for Roclatan™, named Mercury 1, is a 12-month safety trial, which had a successful 90-day efficacy readout in September 2016. The 12-month safety data from this trial are expected in the third quarter of 2017. The second Phase 3 registration trial, named Mercury 2, is a 90-day efficacy trial, which just completed and is the subject of this press release. The topline 90-day efficacy readouts for both Mercury 1 and Mercury 2 demonstrated that Roclatan™ was statistically superior to each of its components, thus achieving their primary clinical endpoints. Aerie expects to submit a Roclatan™ NDA to the U.S. Food and Drug Administration (FDA) in the first half of 2018. A third Phase 3 registration trial, named Mercury 3, is expected to commence in Europe in mid-2017. Mercury 3 is not necessary for approval in the U.S., but rather to facilitate regulatory approval and commercialization in Europe.
Rhopressa™ (netarsudil ophthalmic solution) 0.02%, is a novel eye drop that the Company believes, if approved, would become the only once-daily product available that, based on Aerie's preclinical and clinical studies to date, specifically targets the trabecular meshwork, the eye's primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Preclinical and clinical studies have also demonstrated that Rhopressa™ lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, based on Aerie's preclinical studies, Rhopressa™ may provide an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, the active ingredient in Rhopressa™, netarsudil, has been shown in Aerie studies to inhibit both Rho kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have also shown that Rhopressa™ may have disease-modifying properties, including an anti-fibrotic effect of netarsudil on trabecular meshwork cells and the potential to increase perfusion of the trabecular meshwork.
The results of two Phase 3 registration trials (Rocket 2 and Rocket 1) for Rhopressa™ were included in the NDA submission to the FDA in February 2017. There were two additional Phase 3 registration trials for Rhopressa™, named Rocket 3 and Rocket 4. Rocket 3 was a small 12-month safety-only study in Canada that was not necessary for the NDA submission and for which enrollment has been discontinued. Rocket 4, which was successfully completed in April 2017, was designed to provide adequate six-month safety data for regulatory filing purposes in Europe, and was also not necessary for the NDA submission. The 90-day efficacy results from Rocket 4 and Mercury 1, the initial Phase 3 registration trial for Aerie product candidate Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, were also included in the Rhopressa™ NDA submission as supportive. The FDA has set the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA's review of the Rhopressa™ NDA for February 28, 2018.
About Aerie Pharmaceuticals, Inc.
Aerie 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's two current product candidates are once-daily intraocular pressure lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA for Rhopressa™ (netarsudil ophthalmic solution) 0.02% was submitted to the FDA in February 2017, and, in May 2017, the FDA set the PDUFA goal date for the completion of the FDA's review of the Rhopressa™ NDA for February 28, 2018. Aerie's second product candidate, Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of Rhopressa™ and widely prescribed PGA latanoprost, achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1, which is still ongoing, and Mercury 2. A Roclatan™ NDA submission is expected to take place in the first half of 2018. Aerie is also focused on the development of additional product candidates and technologies in ophthalmology.
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "exploring," "pursuing" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current and potential future product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to request, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, our product candidates, including the expected timing of, and timing of regulatory and/or other review of, filings for our product candidates; our expectations regarding the commercialization and manufacturing of our product candidates; the potential advantages of our product candidates; our plans to pursue development of additional product candidates and technologies in ophthalmology, including development of our product candidates for additional indications and other therapeutic opportunities; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma; our ability to protect our proprietary technology and enforce our intellectual property rights; and our expectations regarding strategic operations, including our ability to in-license or acquire additional ophthalmic products or product candidates or technologies. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, industry change and other factors beyond our control, and depend on regulatory approvals and economic and other environmental circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading "Risk Factors" in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). In particular, the topline Mercury 2 data presented herein is preliminary and based solely on information available to us as of the date of this press release and additional information about the results may be disclosed at any time. The receipt of the PDUFA goal date notification does not constitute FDA approval of the Rhopressa™ NDA, and there can be no assurance that the FDA will complete its review by the PDUFA goal date, that the FDA will not require changes or additional data, whether as a result of recommendations, if any, made by any FDA advisory committee or otherwise, that must be made or received before it will approve the NDA, if ever, or that the FDA will approve the NDA. In addition, the preclinical research discussed in this press release is preliminary and the outcome of such preclinical studies may not be predictive of the outcome of later clinical trials. Any future clinical trial results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the preclinical research findings discussed in this press release. Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Source: Aerie Pharmaceuticals, Inc.
Posted: May 2017
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