Santen and Aegle Therapeutics Enter Commercialization Agreement for Ophthalmic Drug ARVN001 with Up to $85 Million in Payments

On November 13, Santen Pharmaceutical Co., Ltd. and Arctic Vision announced that Arctic Vision has granted Santen Pharmaceutical the exclusive commercialization rights of ARVN001 (triamcinolone acetonide suprachoroidal injectable suspension) under development in mainland China. According to the agreement,Arctic Vison to Receive Upfront and Milestone Payments Totaling Up to 85 Million USD。

ARVN001 is a triamcinolone acetonide suprachoroidal injectable suspension specifically designed for suprachoroidal administration. This innovative suprachoroidal delivery method allows the drug to rapidly and fully diffuse to the posterior segment of the eye with prolonged effect, while significantly reducing adverse effects on normal intraocular tissues.

The drug has been approved by the FDA in the United States for the treatment of uveitic macular edema (UME). It is the first and currently the only approved suprachoroidal therapy for UME, and it is also being developed for other retinal diseases such as diabetic macular edema (DME).

In March 2020, Arctic Vision acquired the exclusive rights for the development and commercialization of ARVN001 in Greater China (Mainland China, Hong Kong, Macao, and Taiwan) and South Korea from Clearside Biomedical Inc. In August 2021, Arctic Vision obtained the exclusive rights for ARVN001 in the ten ASEAN countries and India. In September 2021, Arctic Vision further expanded the territory for ARVN001 rights by securing exclusive authorization in Australia and New Zealand.

In July 2024, Arctic Vision announced positive topline results from the Phase III clinical trial of ARVN001 in China for UME, while research on the therapy for other retinal eye diseases is ongoing.

Dr. Xiang Yu, President of Santen Pharmaceutical (China), stated: "We are very pleased to have reached a collaboration with Arctic Vision. This marks an important step for both parties in jointly promoting the development of ophthalmic treatments in China. As a leading enterprise in China's ophthalmology market, Santen has a solid foundation in commercial operations and top-tier academic promotion capabilities. These strengths will help ARVN001 serve and meet the significant unmet treatment needs of a large number of Chinese patients suffering from uveitic macular edema as soon as possible. We look forward to combining our resources and expertise with Arctic Vision to maximize the integration of our respective advantages, providing innovative treatment solutions for patients and strongly advancing the long-term development of vitreoretinal disease care in China."

Dr. Hu Haidi, founder, chairman and CEO of Arctic Vision, said: "ARVN001 is expected to become the first and only approved suprachoroidal injection drug in China for the treatment of UME. Arctic Vision has made tremendous efforts to advance ARVN001 from the clinical trial stage to the regulatory submission stage. We are very pleased to have reached a commercial partnership with Santen Pharmaceutical (China) Co., Ltd. for this cutting-edge therapy. With Santen’s strong commercial capabilities, we look forward to maximizing the potential of this product and bringing innovative solutions to UME patients and eye care professionals in China."

Uveitis refers to the inflammation of the uvea, the vascular layer between the sclera (the outer protective layer of the eye) and the retina, which can lead to severe visual impairment. The uvea consists of the choroid at the back, the ciliary body in the middle, and the iris at the front. Uveitis is a common cause of low vision or blindness, with an incidence rate of approximately 17/100,000 to 52/100,000 in European and American countries and a prevalence rate of 38/100,000 to 714/100,000. China has millions of patients with uveitis, primarily young and middle-aged working individuals. Macular edema is one of the common complications of uveitis, characterized by fluid accumulation leading to swelling in the macula, the area of the retina responsible for the sharpest vision. Uveitic macular edema poses a serious threat to patients' vision and quality of life, imposing a heavy burden on patients, their families, and society.

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