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Roclatan achieves primary efficacy endpoint in phase 3 Mercury 1 trial
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Roclatan, a fixed-dose prostaglandin combination eye drop, reduced IOP more than each of its individual components at all time points measured, thus meeting its 90-day primary efficacy endpoint in the Mercury 1 trial, Aerie Pharmaceuticals announced.
As part of the 12-month phase 3 trial, Roclatan (netarsudil 0.02%, latanoprost ophthalmic solution 0.005%) was dosed daily, and IOP reduction was compared with daily dosing of each of its components in patients with maximum baseline IOP between 20 mm Hg and 36 mm Hg. Roclatan reduced IOP between 1.3 mm Hg and 2.5 mm Hg more than latanoprost and between 1.8 mm Hg and 3 mm Hg more than Rhopressa (netarsudil), according to a company press release.
Mean diurnal IOP was reduced to 16 mm Hg or less in 61% of patients, a greater percentage than in patients receiving either of the individual components, according to the release.
“The safety profile of Roclatan observed thus far in Mercury 1 points to a safe and tolerable product,” Richard A. Lewis, MD, chief medical officer of Aerie, said in the release.
The most common adverse event was hyperemia, which was reported in about 50% of patients.