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Aerie initiates first phase 3 registration trial of Roclatan
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Dosing is underway for the first patients enrolled in Mercury 1, the first phase 3 registration trial of Roclatan, Aerie Pharmaceuticals announced in a press release.
Roclatan is a once-daily, quadruple-action eye drop being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension, the release said.
The company anticipates enrolling 690 patients in the three-arm 1-year safety study with a 90-day efficacy readout.
The clinical endpoint of Mercury 1 will compare Roclatan for superiority over each of its two components, Rhopressa and latanoprost.
“Having just reported the successful phase 3 efficacy results for our single-agent product candidate Rhopressa, we believe Roclatan, which combines Rhopressa with the market leading [prostaglandin analogue] in a fixed-dose combination, has significant IOP-lowering potential,” Vicente Anido Jr., PhD, CEO and chairman of Aerie, said in the release.
The company anticipates reporting 90-day efficacy results of the Mercury 1 study in 1 year. Two more Roclatan phase 3 trials are expected to begin in 2016, one in the U.S. and one in Europe.