Japanese approval for Senju’s Avarept

Japan’s Senju Pharmaceutical has announced that Avarept ophthalmic suspension 0.3% (motugivatrep), discovered and licensed by Mochida Pharmaceutical (TYO: 4534) and developed by Senju as an eye drop treatment for dry eye disease (DED), has obtained manufacturing and marketing approval in Japan.

Avarept represents a novel therapy for DED with transient receptor potential cation channel subfamily V member 1 (TRPV1) antagonist, designed to improve both subjective symptoms and objective signs of DED through inhibition of TRPV1. A pivotal Phase III clinical trial conducted by Senju successfully met the primary endpoint by demonstrating statistically significant improvement in dry eye symptom severity, as measured by a 15-item patient-reported questionnaire, the Dry Eye-Related Quality-of-Life Score (DEQS). This achievement marks the world’s first successful clinical development of a TRPV1 antagonist for DED, completed in Japan.

DED, the target disease of SJP-0132, is defined as “A multifactorial disease characterized by an unstable tear film causing discomfort and/or visual impairment, accompanied by ocular surface disorder”). Recently, the number of DED patients has been increasing due to an aging population, the long-term use of contact lenses, and the widespread use of visual display terminals (VDT) such as PCs and Smartphones.