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    Rocket 2 meets safety endpoints for netarsudil

    A 12-month initial safety analysis found similar outcomes to the 90-day efficacy period

    Take-home message: Netarsudil ophthalmic solution 0.02% q.d. maintained consistent IOP-lowering efficacy through 12 months for the Rocket 2 trial.

     

     

    Irvine, CA—Rocket 2—the second pivotal phase III registration trial for netarsudil ophthalmic solution 0.02% (Rhopressa), a novel once-daily eye drop being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension—demonstrated safety results consistent with those observed for the 90-day efficacy period, according to developer Aerie Pharmaceuticals.

    The study compared Rhopressa once a day with timolol twice a day, said Richard A. Lewis, MD, chief medical officer for Aerie.

    “It was designed as a non-inferiority study to showed equivalence in efficacy at each time point,” Dr. Lewis said. “We’re happy with how it performed.

    “In terms of other aspects, it seems to be exactly what we thought. Very similar to what we found in our phase II trials,” he said, adding full results after data lock are likely sometime in the late second quarter or early third quarter.

    Aerie has designed Rocket 2 as the pivotal trial for U.S. registration, with Rocket 1 as supportive data, Dr. Lewis said. (Aerie is also conducting two additional studies on Rhopressa—Rocket 3 and 4—neither of which is necessary for U.S. regulatory filing.)

    Rocket 2 details

    The Rocket 2 study enrolled 756 patients, randomly assigned to Rhopressa once a day, Rhopressa twice a day, or timolol twice a day, with a 3-month interim efficacy and a 1-year safety endpoint.

    The company’s primary efficacy endpoint for this study was the mean IOP at all time points through Day 90 (for maximum baseline IOP under 25 mm Hg). A total of 403 patients met entry criteria and were included in the Rocket 2 efficacy analysis.

    Patient disposition in Rocket 2 showed a high level of patient retention through 3 months, with 133/155 patients in the once a day arm (85%) and 154/163 in the timolol arm (94%) completing the initial efficacy portion. The leading cause for discontinuation in the once a day arm was an adverse event, while in the timolol arm it was protocol violations.

    There were 129 patients in the per-protocol once a day arm and 142 in the timolol arm with baseline IOPs under 25 mm Hg. Rocket 2 analyzed nine different time points, three each on Day 15, Day 43, and Day 90.

    The mean diurnal IOP in the once a day arm was 21.4 mm Hg, which decreased to 17.4 mm Hg at Day 90; these changes were seen as early as week 2.

    For the first 118 patients who reached the 12-month mark, Rhopressa once a day demonstrated a consistent level of IOP lowering at 8 am from day 90 through month 12, with a nominal variance of only 0.1 mmHg between day 90 and month 12, Aerie reported.

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