Written By: Pharmacally Medical News Desk
Senju Pharmaceutical has secured manufacturing and marketing approval in Japan for Avarept® (Motogivatrep) Ophthalmic suspension 0.3%, a first-in-class therapy for dry eye disease (DED) that works through inhibition of the transient receptor potential cation channel subfamily V member 1 (TRPV1). The decision marks an important regulatory milestone in offering a novel, mechanism-based option for patients with this common and often chronic ocular condition.
Avarept® (development code SJP-0132) is an ophthalmic suspension formulated at 0.3% strength and designed to target TRPV1, a sensory ion channel expressed in corneal and conjunctival tissues that contributes to pain and inflammation signalling in the eye. By selectively antagonizing TRPV1 activity, the drug aims to reduce discomfort and inflammatory responses associated with dry eye disease.
This mechanism is distinct from existing tear replacements and anti-inflammatory agents. It addresses neurogenic components of dry eye, offering a targeted approach to help alleviate symptoms such as irritation, burning, and stinging common in DED.
Yasushi Taguchi, Executive Officer, Head of Research Division noted that Avarept is the first TRPV1-inhibiting drug discovered by Mochida to gain approval. He expressed hope that it will ease discomfort in people with dry eye and help improve their quality of life.
Clinical Development and Safety Profile
Avarept’s approval follows a comprehensive clinical program, including a pivotal Phase III study conducted in Japan (Study 3-02), which successfully met its primary endpoint. The trial showed a statistically significant improvement in dry eye symptom severity using the Dry Eye-Related Quality-of-Life Score (DEQS), a validated 15-item patient-reported outcome tool. Alongside earlier dose-response studies, these results supported selection of the 0.3% strength and confirmed consistent benefits across both signs and symptoms of dry eye. This also represents the world’s first successful clinical development of a TRPV1 antagonist for dry eye disease completed in Japan, with an overall safety profile that was acceptable and well-tolerated.
Takuro Sekiya, Executive Officer, Head of R&D Division said the company is pleased the approval allows them to provide a new treatment for dry eye, addressing unmet needs. He emphasized that Avarept may relieve symptoms, improve patients’ daily lives, and advance therapy for the condition.
Dry eye disease affects a significant portion of the population, especially with increased screen time, aging demographics, and environmental contributors. TRPV1 is a cation channel that becomes activated by triggers such as capsaicin, heat, inflammatory mediators, and changes in osmotic pressure. In dry eye disease, both tear film hyper-osmolarity and elevated inflammatory molecules are common findings. These conditions are thought to activate or sensitize TRPV1, lowering the activation threshold of corneal sensory nerves.
The result is heightened ocular discomfort, irritation, and pain. By inhibiting TRPV1, Avarept is designed to interrupt this pathway, helping to reduce neurogenic inflammation and improve symptoms associated with dry eye.
With regulatory approval now granted, Senju Pharmaceutical will move toward commercial launch and distribution in Japan. The company’s focus will be on making Avarept® accessible to ophthalmologists and optometrists treating dry eye, supported by appropriate educational efforts to guide its clinical use.
With approval in hand, Senju plans to move ahead with the commercial launch so patients have another option to relieve both the signs and symptoms of dry eye disease. Mochida Pharmaceutical, the parent company behind Avarept’s original discovery, continues to position itself as an innovator in ophthalmic research. By advancing TRPV1-targeted therapy from discovery to approval, Mochida aims to build on its research capabilities and keep contributing to better treatment choices and quality of life for patients living with chronic eye conditions.
Reference
Obtained manufacturing and marketing approval in Japan for Avarept® Ophthalmic suspension 0.3%, a novel treatment of Dry Eye Disease through Transient Receptor Potential cation channel subfamily V member 1 Inhibition, 22 December 2025, Senju, https://www.senju.co.jp/system/files/content_news/2025-12/ENG_20251222.pdf
Hori Y, Wada T, Omatsu K; SJP-0132 clinical study investigators. Efficacy and Safety of SJP-0132 in Patients with Dry Eye Disease: A Phase 2b Randomized, Double-Masked, Dose-Finding Study. Am J Ophthalmol. 2025 Dec 4:S0002-9394(25)00634-8. Epub ahead of print. PMID: 41352685. https://doi.org/10.1016/j.ajo.2025.11.036