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Aerie initiates second phase 3 registration trial of Roclatan

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Aerie Pharmaceuticals began dosing patients enrolled in the second phase 3 registration trial of Roclatan, according to a company press release.

Roclatan (0.02% netarsudil, 0.005% latanoprost ophthalmic solution) is a once-daily eye drop being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension.

The fixed-dose, once daily formulation is a combination of Aerie’s Rhopressa and latanoprost. The Mercury 2 study will enroll approximately 690 patients and will compare Roclatan against each of its two components.

"We currently expect to readout top-line 90-day efficacy data for the trial in the second quarter of 2017. Further, the Mercury 1 top-line 90-day efficacy readout continues to be on track for the third quarter of 2016. Should both Mercury registration trials be successful, we expect to file the NDA for Roclatan in the second half of 2017,” Vicente Anido, Jr., PhD, chairman and CEO of Aerie said in the release.

The company also anticipates commencing Mercury 3, a third phase 3 registration trial for Roclatan, to facilitate regulatory approval and commercialization in Europe.