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Rhopressa fails to meet primary efficacy endpoint of non-inferiority to timolol

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Despite failing to meet its primary endpoint of non-inferiority to timolol, the glaucoma medication Rhopressa compared well with timolol on most key metrics, according to Vincente Anido Jr., PhD, chairman and CEO of Aerie Pharmaceuticals.

Anido delivered 90-day efficacy results of the initial phase 3 Rocket 1 clinical trial during a company-sponsored conference call.

“The Rocket 1 phase 3 trial did not achieve the non-inferiority to timolol that we were expecting,” Anido said. “The original phase 2B trial for Rhopressa did well, and then we did the Rhopressa arm in the Roclatan trials and it did even better. Then here it just didn’t do quite what we expected it to do. So, obviously we were very disappointed with that.”

Rocket 1 included 370 glaucoma patients; 182 patients received Rhopressa once daily and 188 received timolol twice daily.

The primary endpoint was mean IOP at 2 weeks, 6 weeks and 90 days.

Secondary endpoints included an analysis of patients with a baseline IOP above and below 24 mm Hg, mean change from baseline IOP and safety.

Rhopressa failed to show non-inferiority to timolol in a per-protocol analysis of patients with baseline IOP below 27 mm Hg, although these patients had lower IOP than those given timolol at most time points up to 6 weeks, Anido said. Furthermore, Rhopressa showed non-inferiority compared to timolol in patients with baseline IOP below 26 mm Hg, he said.

“In some cases we were actually a little bit better than timolol and in other cases we were worse than timolol,” he said. ”The inferiority that we saw was really driven by a very small subset of Rhopressa patients losing some efficacy over time, about 20% of the patients in the population that we looked at, which is below 27 mm Hg.”

Results showed no drug-related adverse events, Anido said.

Results of the Rocket 2 study, a similar study with a different dosing protocol, are expected to be released in the third quarter 2015. A third trial looking at safety is being conducted in Canada.

Pending study results, Aerie expects to file a new drug application with the FDA by the end of 2016, according to an Aerie press release. – by Matt Hasson