Research & Development
Aerie Pharmaceuticals Completes Enrollment of its first Phase 3 Clinical Trial of Netarsudil Ophthalmic Solution in Japan
18 June 2021 - - US-based ophthalmic pharmaceutical company Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) has completed patient enrollment for its first Phase 3 clinical trial of netarsudil ophthalmic solution in Japan, comparing netarsudil ophthalmic solution 0.02%, administered once a day in the evening, to ripasudil hydrochloride hydrate ophthalmic solution 0.4%, marketed as Glanatec in Japan, administered twice a day, in the morning and evening, the company said.

The first patient to enter this randomized, single-masked, multi-center, parallel-group Phase 3 study was dosed in early December 2020.

A total of 245 patients were successfully randomized across the netarsudil and ripasudil treatment arms.

The netarsudil arm includes a netarsudil drop in the evening and netarsudil ophthalmic solution vehicle administered in the morning to preserve the masking of the trial.

The ripasudil arm is administered twice a day, once in the morning and once in the evening, consistent with the product labeling in Japan.

Aerie and Santen Pharmaceutical Co., Ltd. announced an exclusive collaboration and license agreement for Rhopressa and Rocklatan in Japan and several other Asian countries in October 2020.

As part of this agreement, Santen is responsible for all development and commercialization costs and activities related to the products in the territories covered by the agreement; however, Aerie and Santen have collaborated for this first Phase 3 study for Rhopressa in Japan, which they are co-funding.

The study was designed in accordance with the requirements of Japan's Pharmaceuticals and Medical Devices Agency to support a potential regulatory submission of netarsudil ophthalmic solution in Japan.

The objective of the study, a superiority study, is to evaluate the ocular hypotensive efficacy and safety of netarsudil once daily compared to ripasudil twice daily, over a four-week period in patients with primary open-angle glaucoma or ocular hypertension.

Netarsudil is marketed as Rhopressa in the United States where it is approved for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases.

Aerie's first product, Rhopressa (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by the US Food and Drug Administration for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018.

In clinical trials of Rhopressa, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.

Aerie's second product for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa and the widely-prescribed PGA (prostaglandin analog) latanoprost, was launched in the United States in May 2019.

In clinical trials of Rocklatan, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.

Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema.
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