Santen obtains manufacturing and marketing approval in Japan for Alesion® eyelid cream (epinastine hydrochloride), a new treatment for allergic conjunctivitis


March 26, 2024, Osaka, Japan – Santen Pharmaceutical Co., Ltd. (hereinafter Santen) has announced today that it successfully obtained manufacturing and marketing approval, for a new long-acting, trans-eyelid formulation for treating allergic conjunctivitis, “Alesion® eyelid cream 0.5%” (generic name: epinastine hydrochloride, development code: STN1011402). Alesion® eyelid cream 0.5% is a cream-type formulation to be applied to the periocular area (upper and lower eyelids) once a day. It is the world’s first cream-format treatment for allergic conjunctivitis.

Anti-allergy eye drops (mediator release inhibitors and histamine H1 receptor antagonists) are typically used to treat allergic conjunctivitis, requiring application twice or four times daily. The latest cream requires application to eyelids once daily, delivering the effective ingredient, epinastine hydrochloride, through the eyelids, acting on conjunctiva over a prolonged period. Santen hope that this new formulation will eliminate the burden of eyedrop applications, making it easier for children, and for patients whose mobility issues prevent them from applying their own eyedrops, to take their required dose. Reducing patients’ burden boosts expectations of application compliance, reduces frequency of developing itchiness in the eyes and enhancing patients’ quality of life (QOL).

Epinastine hydrochloride was discovered and developed by Boehringer Ingelheim in 1975. It acts as a histamine H1 receptor antagonist and also inhibits the release of mediators such as histamine from mast cells, making it an effective treatment option for allergic conjunctivitis. Phase III Conjunctival Allergen Challenge trial (randomized, double-masked, placebo-controlled trial) performed in Japan on asymptomatic allergic conjunctivitis patients confirmed its superiority to placebo eyelid cream in scores for pruritus and conjunctival hyperemia, two main symptoms of allergic conjunctivitis. A Phase III trial of the long-term administration of the product showed no serious adverse reactions, recording an incidence rate of 1.6% (2/124) for eyelid itchiness and 0.8% (1/124) for eyelid redness.

“Many patients in Japan complain of strong itchiness, redness and other symptoms as a result of allergic conjunctivitis, resulting in a lower QOL. With the latest approval, we are proud to be able to be the first to provide all-day comfort with once-daily administration, using this treatment option in an unconventional drug form, to patients and healthcare providers alike,” said Peter Sallstig, Chief Medical Officer at Santen.

Allergic conjunctivitis is a condition in which allergens (substances that cause allergic reactions) such as pollen adhere to the surface of the eye, causing inflammation of the conjunctiva. Conjunctivitis that is caused by pollen etc. and become symptomatic only during a specific season is called seasonal allergic conjunctivitis, while conjunctivitis that stays symptomatic throughout the year is called perennial allergic conjunctivitis. According to a 2017 prevalence survey conducted by the former Japanese Society of Ophthalmic Allergy Research (currently Japanese Ocular Allergy Society), the prevalence of allergic conjunctivitis in Japan was 48.7%1, and the rate has been increasing in recent years.

As a specialized company dedicated to eye health, Santen is committed to reducing the loss of social and economic opportunities for people around the world due to eye conditions. We will also enhance the level of convenience in treatments to improve medication compliance, thereby contributing to raising patients’ QOL.

1.  Japanese Ocular Allergy Society Clinical Guideline Development Committee: Guidelines for the Clinical Management of Allergic Conjunctival Disease (3rd ed.). Journal of the Japanese Ophthalmological Society 125(8): 741-785, 2021

About Santen
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen’s mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience “Happiness with Vision.”
For more information, please visit Santen’s website

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Santen Pharmaceutical Co., Ltd.