Aerie Pharmaceuticals reported the successful 6-month topline safety and efficacy results of its Rocket 4 phase 3 clinical trial for product candidate Rhopressa, a novel once-daily eye drop being tested for its ability to IOP in patients with glaucoma or ocular hypertension.
The Rocket 4 trial was designed to provide 6-month safety data adequate for European regulatory filing purposes. Rocket 4 was not necessary for US new drug application (NDA) filing purposes, although data from the 90-day efficacy component of the trial was included in the February 2017 Rhopressa NDA submission as supportive, according to Aerie.
Rocket 4 enrollment totaled approximately 700 patients and was a two-arm, 6-month trial, which included a 90-day efficacy readout evaluating once-daily Rhopressa for noninferiority to twice-daily timolol. The 90-day efficacy readout, which took place in October 2016, demonstrated successful achievement of the 90-day primary efficacy endpoint. This final readout from Rocket 4 includes 6-month safety data and diurnal efficacy measurements at months 4, 5, and 6, which do not constitute a primary efficacy endpoint.
Rhopressa Phase 3 6-Month Topline Highlights for Rocket 4
• The objective of the Rhopressa Rocket 4 clinical trial is to provide 6-month safety data adequate for regulatory filing in Europe and is not required for U.S. FDA approval.The European regulatory filing for Rhopressa is currently expected to take place in the second half of 2018.
• Safety data observed over the 6 months were consistent with observations in previous Rhopressa 3-month and 12-month phase 3 clinical trials.
• The most common Rhopressa 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 Rhopressa 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.
• Rhopressa performance at months 4, 5, and 6 remained within the noninferiority range compared to timolol at each of the IOP measurement time points, including 8 am, 10 am, and 4 pm 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 6-month efficacy results for Rhopressa demonstrated a consistent level of IOP lowering across all baseline IOPs in the trial, and consistent IOP lowering throughout the 6-month period.
“These successful 6-month Rocket 4 safety and efficacy results reconfirm, as observed in our previous clinical trials, that Rhopressa is an efficacious and well-tolerated drug. Rocket 4 represents the final Phase 3 clinical trial for Rhopressa, and we now possess clinical data on Rhopressa for well over 2,000 patients,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release.
“We look forward to our upcoming 90-day efficacy readout later this quarter from Mercury 2, the second phase 3 registration trial for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%. Mercury 2 is structured consistently with Mercury 1, but is of 90-day duration. The 12-month safety data from Mercury 1 are expected in the third quarter of this year," Dr. Anido said.