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Study Finds Rhopressa Noninferior to Timolol for Glaucoma Treatment

Aerie Pharmaceuticals eyedrop achieves primary clinical endpoint in Rocket 2 study

Rhopressa, an eyedrop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, met its primary efficacy endpoint in a phase III trial by demonstrating its noninferiority compared with timolol.

Rhopressa, dosed both once daily and twice daily, was noninferior to twice-daily timolol, Aerie Pharmaceuticals reported. Timolol is the most widely used comparator. The primary efficacy endpoint evaluated subjects with prestudy baseline IOPs of above 20 to below 25 mm Hg.

The Rocket 2 trial’s efficacy results for Rhopressa demonstrated a consistent level of IOP lowering across all baseline IOPs and throughout the 90-day efficacy period.

The most common Rhopressa adverse event was hyperemia (eye redness), which was reported as increased in 35% of patients and was scored as mild for 83% of patients in the Rhopressa once-daily arm of the trial. The adverse event profile for the Rhopressa once-daily arm was consistent with the results of Rocket 1.

There are four phase III registration trials for Rhopressa. Rocket 2 is a 12-month safety trial with a 90-day interim efficacy readout. Safety data for the 12-month period of the Rocket 2 trial is expected in late 2015 or early 2016. Rocket 1, the results of which were initially reported in April 2015, was a 90-day efficacy trial that did not achieve its primary endpoint but did achieve a prespecified secondary endpoint. Rocket 3, a 12-month safety-only study in Canada, is in progress. Rocket 4 is expected to start in late September 2015.

Rhopressa, if approved, would become the only once-daily product that specifically targets the trabecular meshwork, the eye's primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Preclinical results have demonstrated that Rhopressa also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, Rhopressa provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, Rhopressa is known to inhibit both rho kinase and norepinephrine transporter. Recent preclinical studies have shown that Rhopressa may have disease-modifying properties, including an antifibrotic effect on the trabecular meshwork and the potential to increase perfusion of the trabecular meshwork. Preclinical research is also under way to evaluate the potential neuroprotective benefits of Rhopressa.

Aerie expects to file its new drug application for Rhopressa in mid-2016.

Source: Aerie Pharmaceuticals; September 16, 2015.

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