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Roclatan demonstrates positive safety results at 12 months in phase 3 trial
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Aerie Pharmaceuticals released successful 12-month safety results for the Mercury 1 phase 3 registration trial for Roclatan, a once-daily eye drop to lower IOP.
The 12-month safety and efficacy trial, which included a 90-day efficacy endpoint, showed consistent safety results for Roclatan, a combination of Rhopressa (netarsudil ophthalmic solution 0.02%) and latanoprost, with no new adverse events after the initial 90-day efficacy period of the trial, according to a company press release.
“The safety data for the 12 months was consistent with previous Roclatan 3-month safety results. We didn’t see anything that was drug related or systemic adverse events. Very consistent with everything we’ve seen before,” Vicente Anido Jr., PhD, chairman and CEO of Aerie, said in a company conference call.
In addition, patients’ IOP was measured at 8 a.m., 10 a.m. and 4 p.m. at months 6, 9 and 12. Roclatan lowered IOP in a range from 1 mm Hg to 3 mm Hg, exceeding both latanoprost and Rhopressa individually.
“From the efficacy point of view, Roclatan was incredibly effective. It was very stable and consistent all the way through, starting with the primary endpoint of 90 days, or month 3, and we maintained that at a superiority over latanoprost and Rhopressa, which again is what we had to do in this trial. We also maintained the 1 mm Hg to 3 mm Hg benefit of Roclatan over each of the individual components, and we did so all the way through month 12,” Anido said in the call.
Mean diurnal IOP was reduced to 16 mm Hg or lower in 60% of patients in the study, according to the release.
The safety and efficacy data gathered from the study will be used in the company’s expected new drug application submission to the FDA in the first half of 2018.