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Aerie completes enrollment in second phase 3 registration trial of Rhopressa
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Aerie Pharmaceuticals completed enrollment in a second phase 3 registration trial of Rhopressa, according to a press release.
Rocket 2 will measure efficacy over 3 months and safety over 1 year of Rhopressa, a once-daily eye drop that may lower IOP in patients with glaucoma or ocular hypertension. The primary efficacy endpoint is to show non-inferiority of IOP lowering for Rhopressa compared with timolol.
The phase 3 program also includes Rocket 1, a 90-day efficacy registration trial, and Rocket 3, a 1-year safety-only registration trial in Canada.
“Our Rhopressa phase 3 program maintains its strong momentum, with the Rocket 2 trial proceeding with full enrollment and on track for efficacy results in the third quarter of 2015. The Rocket 1 efficacy results are still expected mid-second quarter of this year,” Vicente Anido Jr., PhD, CEO and chairman of Aerie, said in the release.
Aerie expects to submit a new drug application filing by mid-2016, pending the results of the Rhopressa phase 3 program, the release said.