Aerie Pharmaceuticals Reports Positive Topline Efficacy Results of Rocket 4 Phase 3 Trial of RhopressaTM (netarsudil ophthalmic solution) 0.02%
- Study Successfully Achieves Primary Efficacy Endpoint -
- Company Separately Announces Withdrawal of RhopressaTM
NDA, with the Expectation of Refiling in
Conference Call and Webcast Today,
Rocket 4 enrolled a total of approximately 700 patients and is a two-arm six-month trial, which includes a 90-day efficacy readout evaluating once-daily RhopressaTM for non-inferiority to twice-daily timolol. The range for the primary endpoint includes patients with baseline IOPs from above 20 mmHg (millimeters of mercury) to below 25 mmHg.
The study achieved its primary efficacy endpoint demonstrating non-inferiority of once-daily RhopressaTM compared to twice-daily timolol.
Separately, Aerie announced that it has withdrawn the RhopressaTM
NDA (new drug application) that was submitted to the
Management will host a conference call and provide accompanying slides
to discuss the clinical results and the RhopressaTM NDA at
RhopressaTM Phase 3 Highlights for Rocket 4
- RhopressaTM dosed once-daily achieved its primary efficacy endpoint demonstrating non-inferiority compared to twice-daily timolol for patients with baseline IOPs ranging from above 20 to below 25 mmHg.
- RhopressaTM also demonstrated non-inferiority compared to timolol at the pre-specified secondary endpoint range of above 20 mmHg to below 27 mmHg, and also at a range of above 20 mmHg to below 28 mmHg.
- The Rocket 4 efficacy results for RhopressaTM demonstrated a consistent level of IOP lowering across all baseline IOPs in the trial, and throughout the 90-day efficacy period.
- The most common RhopressaTM adverse event was hyperemia, or eye redness, which was reported in approximately 40 percent of patients, 85 percent of which was scored as mild. Other adverse events, which have also been observed in previous RhopressaTM clinical trials, were reported in 5 percent to 12 percent of patients. There were no drug-related systemic or serious adverse events.
"These successful Rocket 4 topline efficacy results once again confirm
that RhopressaTM is a highly efficacious and well-tolerated
drug. In fact, RhopressaTM performed better at the higher
baseline ranges in Rocket 4 than in both Rocket 1 and Rocket 2. This is
in addition to RhopressaTM having demonstrated
non-inferiority to latanoprost for baseline IOP ranges of above 20 mmHg
to below 25 mmHg in the recent readout from the Mercury 1 clinical
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, based on Aerie's preclinical studies, specifically targets the trabecular meshwork, the eye's primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Preclinical studies have also demonstrated that RhopressaTM lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, based on Aerie's preclinical studies, RhopressaTM provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, RhopressaTM has been shown in Aerie studies to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have also 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 results of two Phase 3 registration trials (Rocket 2 and Rocket 1)
for RhopressaTM were included in a NDA filing submitted to
Conference Call / Web Cast Information
Aerie management will host a live conference call and webcast at
The live webcast and a replay may be accessed by visiting Aerie's
website at http://investors.aeriepharma.com.
In addition, key data slides from the RhopressaTM Rocket 4
study will be discussed on the conference call and are posted to Aerie's
website. Please connect to Aerie'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
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 lead product candidates are once-daiIy IOP-lowering
therapies with novel mechanisms of action to treat patients with
glaucoma or ocular hypertension. The NDA filing for RhopressaTM
(netarsudil ophthalmic solution) 0.02% was originally submitted in the
third quarter of 2016 and is expected to be resubmitted in
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