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Acucela, Otsuka announce phase 3 trial for novel dry eye treatment
Otsuka Pharmaceutical and Acucela are initiating a phase 3 clinical trial of a treatment candidate for dry eye syndrome, according to a press release.
The study will evaluate rebamipide ophthalmic suspension, a novel compound intended to increase the level of mucin in the tear film. The drug is marketed for dry eye in Japan as Mucosta ophthalmic suspension UD 2%, the release said.
The multicenter, randomized, placebo-controlled, double-masked, parallel-group study is expected to enroll about 560 participants and be completed by the end of 2013.
Acucela has two additional product candidates under clinical development in the United States: Otsuka ACU-4429, an oral therapy to slow progression of dry age-related macular degeneration, and OPA-6566, an adenosine A2a receptor antagonist to lower IOP in patients with open-angle glaucoma or ocular hypertension.