Aerie Pharmaceuticals Reports Positive Rocket 4 Six-Month Topline Safety and Efficacy Results for RhopressaTM (netarsudil ophthalmic solution) 0.02%
Conference Call and Webcast Today,
Rocket 4 enrollment totaled approximately 700 patients and was a two-arm
six-month trial, which included a 90-day efficacy readout evaluating
once-daily RhopressaTM for non-inferiority to twice-daily
timolol. The 90-day efficacy readout, which took place in
Management will host a conference call and provide accompanying slides
to discuss these results at
RhopressaTM Phase 3 Six-Month Topline Highlights for Rocket 4
The objective of the RhopressaTM Rocket 4 clinical trial is
to provide six-month safety data adequate for regulatory filing in
Europeand is not required for U.S. FDAapproval. The European regulatory filing for RhopressaTM is currently expected to take place in the second half of 2018.
- Safety data observed over the six months were consistent with observations in previous RhopressaTM three-month and twelve-month Phase 3 clinical trials.
- The most common RhopressaTM adverse event was hyperemia, or eye redness, which was reported in approximately 48 percent of patients, 75 percent of which was mild. Other adverse events, which have also been observed in previous RhopressaTM clinical trials, were reported in 5 percent to 25 percent of patients, consistent with the 12-month safety data from Rocket 2. There were no drug-related systemic or serious adverse events.
RhopressaTM performance at months four, five and six
remained within the non-inferiority range compared to timolol at each
of the intraocular pressure (IOP) measurement time points, including
8 a.m., 10 a.m., and 4 p.m.at baseline IOPs ranging from above 20 mmHg (millimeters of mercury) to below 25 mmHg, and also from above 20 mmHg to below 27 mmHg.
- The Rocket 4 six-month efficacy results for RhopressaTM demonstrated a consistent level of IOP lowering across all baseline IOPs in the trial, and consistent IOP lowering throughout the six-month period.
"These successful six-month Rocket 4 safety and efficacy results
reconfirm, as observed in our previous clinical trials, that RhopressaTM
is an efficacious and well-tolerated drug. Rocket 4 represents the final
Phase 3 clinical trial for RhopressaTM, and we now possess
clinical data on RhopressaTM for well over 2,000 patients,"
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 and clinical studies, specifically targets the trabecular meshwork, the eye's primary fluid drain and the diseased tissue responsible for elevated intraocular pressure (IOP) in glaucoma. Preclinical and clinical 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 may provide an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, the active ingredient in RhopressaTM, netarsudil, 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 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 RhopressaTM were included in the NDA submission to the
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 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 (
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 intraocular
pressure-lowering therapies with novel mechanisms of action to treat
patients with glaucoma or ocular hypertension. The NDA for RhopressaTM
(netarsudil ophthalmic solution) 0.02% was submitted to the
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