Contribution to Ophthalmology

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 been provided to and utilized by more than 2,000 medical institutions until FY2024 in Japan. A report(*) says that the introduction of ACT Pack^® increased the six-month adherence rate from 42.1% to 94.2%.

This program has been introduced to outside of Japan. In Asia, ACT Pack^® is digitalized as a communication tool for healthcare providers and patients to encourage patients to continue treatment.

The World Glaucoma Association and the World Glaucoma Patients Association play leading roles in performing various knowledge-sharing activities around the world for one week in March designated as the World Glaucoma Week (WGW), aiming to build public awareness of glaucoma.

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

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.

The Company donates pharmaceuticals and medical devices such as intraocular lenses for groups which conduct ophthalmic care activities in developing countries.
In donating products, we ensure compliance with WHO guidelines for drug donations, relevant national and regional laws and regulations, and industry self-imposed regulations.

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 highlight 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.

Santen has obtained approval for Verkazia in a broad range of countries across the EU, 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 (*3), 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).

1. Hamel C. Retinitis pigmentosa. Orphanet J Rare Dis. 2006;1:40.
2. Japanese Ophthalmological Society
   https://www.nichigan.or.jp/public/disease/name.html?pdid=53
3. jCell: A cell therapy product under development, primarily composed of retinal progenitor cells