Market Penetration of Products with Social Significance

Santen will contribute to reducing the number of untreated patients by improving access to healthcare in the field of ophthalmology, which is our business field.

Improving Access to Healthcare by Ophthalmology and Wellness as Two of the Three Material Strategies

Santen's materiality framework comprises three strategies and four areas of ESG materiality. In the strategy of "Ophthalmology," one of our three strategies (Ophthalmology, Wellness, and Inclusion), we will accelerate innovation in ophthalmology and ecosystem(*1) development, and in "Wellness," we will raise awareness and proactive care toward better eye condition.

Through these efforts, we will contribute to reducing the number of untreated patients worldwide by developing products with social significance and improving access to ophthalmic treatment for more and more people. We aim to contribute to more than 60 million patients(*2) by 2025. We have contributed around 48 million patients in FY2020.

  1. Ecosystem: The ophthalmic care ecosystem is an aggregate of various stakeholders that contribute to the provision of ophthalmic care and collaborative relationships in which they function organically.
  2. Estimated total no. of patients to which Santen contributed (disease areas: inflammation/allergies, cornea, glaucoma, cataracts) in FY2019 was approx. 43 million, calculated based on JMDC's estimated total no. of patients for Santen's Rx products and Santen's shipment data

Improving Access to Healthcare in Accordance with the Characteristics of Local Communities

We recognize poor access to health and medical care in many emerging countries as a serious issue to be solved. In such countries, a shortage of ophthalmologists and other professionals related to ophthalmic treatment has prevented patients from receiving adequate medical treatment or even being correctly diagnosed. In addition, a shortage of medical technicians involved in examinations has forced ophthalmologists to conduct even basic examinations on their own, resulting in a general decrease in productivity. To enable such ophthalmologists to increase their skills in cataract surgery and glaucoma treatment and spend more time treating their patients, Santen works with external partners to offer training systems and medical information to ophthalmologists. Moreover, we also devote serious efforts to educating medical examination staff, who provide doctors with valuable support. We therefore aim to improve medical access in emerging countries.

Concept of Intellectual Property Rights in Developing Countries

Santen is aware that people have difficulty access to healthcare due to economic reasons and a degree of flexibility is required in some countries and regions. In view of this, until the issue of drug access is resolved, we will not file new patent applications in principle and enforcement of patents filed or obtained in the company’s sole name before will be limited to the necessary minimum range not to hinder access to healthcare in Least Developed Countries defined by the United Nations(*1) and Low Income Countries defined by the World Bank(*2).

  1. Least Developed Countries defined by the United Nations: Department of Economic and Social Affairs
  2. Low Income Countries defined by the World Bank: The World Bank: Data

Initiatives to Combat Rare Diseases

Development and research for orphan drugs sometimes suffer delays because of the very small number of patients, despite their very serious need for this kind of drug. Santen is also strongly committed to improving medical access for patients suffering from rare diseases in the ophthalmic field.

Verkazia, a vernal keratoconjunctivitis (VKC) treatment

Vernal keratoconjunctivitis (VKC) is a recurrent serious allergic eye condition, most common in children and adolescents, characterized by severe inflammation of the ocular surface, including corneas and conjunctivas. Its symptoms include intense eye itching, eye pain, and high light sensitivity, which can hinder the daily lives of patients. Without adequate treatment, severe cases may cause corneal ulcers and visual impairments.

Santen has developed and been marketing Verkazia, a cyclosporine ophthalmic emulsion for VKC, which features a long-time stay on the ocular surface and improved corneal absorption based on Santen's proprietary cationic nanoemulsion technology.

As of June 2022, Santen has obtained approval for Verkazia in more than 10 countries in the Americas, Asia, including China, and other regions. To remove the limitations imposed by VKC on the activities of young patients around the world and help them return to as comfortable a daily life as possible, we are doing our best to facilitate the supply of this product.

jCell, a gene therapy agent for retinitis pigmentosa

Retinitis pigmentosa is an eye condition of a wide range of degeneration of retinal neuroepithelium and pigment epithelium, caused by a gene mutation. With night blindness, visual field defects, and low vision as its characteristic symptoms, this disease is caught mainly by teenagers, slowly progresses, and may often cause vision loss in severe cases in their middle and old ages. It is estimated that approximately 1.9 million people around the world suffer from this disease,(*1) and that there are 18.7 patients per 100,000 population in Japan.(*2) Retinitis pigmentosa forces patients to experience various difficulties in their daily lives, especially in activities that necessitate vision, such as travel and studying, but no fundamental therapy or treatment for progression control is currently available. Therefore, this disease involves very serious unmet medical needs.

As part of its efforts to establish a gene therapy business, Santen has concluded an exclusive licensing agreement with U.S.-based jCyte for the rights to develop and market jCell, which is being developed as a first-in-class treatment for retinitis pigmentosa.

  1. Hamel C. Retinitis pigmentosa. Orphanet J Rare Dis. 2006;1:40.
  2. Japanese Ophthalmological Society http://www.nichigan.or.jp/public/disease/momaku_shikiso.jsp