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Roclatan meets primary efficacy endpoint in phase 3 study
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Roclatan, a once-daily fixed-dose combination drug for lowering IOP, has achieved its primary efficacy endpoint in the Mercury 2 phase 3 study, Aerie Pharmaceuticals announced in a press release.
The 90-day trial compared Roclatan — a combination of Rhopressa (netarsudil ophthalmic solution 0.02%) and latanoprost — with monotherapy of each of its components. IOP was measured three times daily at 2 weeks, 6 weeks and 90 days. Roclatan reduced IOP between 1.5 mm Hg and 2.4 mm Hg more than latanoprost alone and between 2.2 mm Hg and 3.3 mm Hg more than Rhopressa alone, the release said.
Mean diurnal IOP was reduced to 16 mm Hg or lower in 56% of patients.
“With this positive Mercury 2 data, we now have two successful pivotal trials for Roclatan. The topline efficacy results demonstrated in Mercury 2 are consistent with Mercury 1, confirming the potential for Roclatan to become the most efficacious IOP-lowering therapy to enter the market, if approved,” Vicente Anido Jr., PhD, Aerie chairman and CEO, said in the release.
The company plans to submit a new drug application to the FDA in the first half of 2018 if safety results from the Mercury 1 trial are successful, he said.