Contribution to Ophthalmology

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 50 million patients(*1) by 2025. We have contributed around 48 million patients in FY2020 and 50 million patients in FY2021.

Glaucoma is the leading cause of vision loss in Japan. One of the challenges concerning glaucoma is that many patients with this almost symptomless disease discontinue their medical treatment. As an initiative to encourage glaucoma patients to continue to receive medical treatment, Santen has developed ACT Pack^®, a glaucoma treatment adherence program. This program has so far been provided to and utilized by more than 2,000 medical institutions. A report(*) says that the introduction of ACT Pack^® increased the six-month adherence rate from 42.1% to 94.2%.

We will expand this initiative to other countries outside of Japan, mainly in Asia.

As a global activity not targeting any specific regions, Santen has been releasing a new version of the Glaucoma Vision Simulation app to inspire many more people, including ordinary people, medical professionals, patients, and their caretakers to deepen their understanding of glaucoma.
The Glaucoma Vision Simulation app is available for download from;

• [iPhone/iPad] App Store
• [Android] Google Play

Dry eye is a modern-day disease whose concept was introduced to Japan around 1985. The number of potential patients with dry eye disease is estimated at 8 to 22 million in Japan. Of those only around 2 million are estimated to receive treatment prescribed by a doctor. The Santen Group aims to contribute to as many dry eye syndrome patients as possible by providing potential dry eye patients with the opportunities to accurately know and understand the disease and encouraging them to consult eye doctors and receive ophthalmic treatment. To accomplish the aim, we have continued to run campaigns to raise public awareness of dry eye syndrome, by sharing a wide range of information, and other means.

In addition, we recognize that, despite its expected effectiveness, continuous dry eye treatment involves some challenges. The challenges faced by doctors include the effort and experience required to correctly diagnose dry eye and the difficulty in giving thorough explanations to patients while busily performing their daily medical duties. The challenges faced by patients include the difficulty in recognizing the current state and improvements of their own eyes, which can demotivate them and, as a common consequence, lead them to discontinue receiving medical treatment. To help solve these challenges, Santen developed TEARMIRU^®, a dry eye treatment support system, which is expected to increase patient satisfaction in treatment, and launched it for sale in April 2023. This system enables patients to visually understand the current state of their own eyes and recognize improvements and the effects of treatment on their symptoms. Moreover, explanations given in the system about the subtype of dry eye they suffer from are expected to help patients understand the purpose of treatment and consequently increase their motivation to continue to receive dry eye treatment.

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.

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.

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 2023, 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.

Retinitis pigmentosa, a disease caused by genetic mutations, causes wide-ranging degeneration of retinal photoreceptor cells and retinal pigment epithelial cells. Characteristic symptoms caused by the condition include night blindness, narrowing of the visual field, and decreased visual acuity. It often strikes people in their teens, with many patients rendered blind by middle age. Worldwide, approximately 1.9 million patients suffer from the disease(*1). In Japan, estimates suggest 18.7 people per 100,000 of population have the condition(*2). Retinitis pigmentosa has a wide impact on everyday life as it affects any operation requiring vision including movement and learning. There are currently very few treatments available for retinitis pigmentosa, with no treatments being available for all forms of the diseases, irrespective of the underlying genetic cause. Therefore, this is an area of significant unmet medical need.

As part of its efforts to unlock the power of cell and gene therapies to address high unmet medical needs in ophthalmology, Santen has concluded an exclusive licensing agreement with U.S.-based jCyte for the rights to develop and market jCell, an investigational cell therapy with the potential to be a first-in-class, gene-agnostic treatment for retinitis pigmentosa. jCell has been granted Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) based on early clinical data, and has also received Orphan Drug designation from both the FDA and the European Medicines Agency (EMA).