Clinical trial in China of new drug for major eye disease

The first clinical trial approved in China for presbyopia drug has its first patient enrolled in Phase III. It is expected to be the first approved drug for presbyopia, an eyesight problem, in China, said the developer Arctic Vision, a Shanghai-based innovation company.

The Phase III study is a double-masked, placebo-controlled, randomized and multicenter trial evaluating the efficacy and safety of the drug, which is called ARVN003, in achieving temporary improvement in vision for adults with presbyopia.

Presbyopia is a physiological condition that makes it difficult to read and work in near distance. It is caused by the hardening of the lens and weakening of the ciliary muscle and often occurs with aging.

According to doctors, pre-presbyopia typically affects people between the ages of 35 and 45; early presbyopia affects people between the ages of 45 and 52; and late presbyopia, also known as absolute presbyopia, affects people over the age of 52.

Nearly a quarter of the world's population is affected by presbyopia. With the rise of the aging population in China, the nation is seeing a year-on-year increase in the number of sufferers.

Latest data shows more than 390 million people in China had been diagnosed with presbyopia in 2021.

Current treatment options for presbyopia include presbyopic reading glasses, contact lenses and surgery.

But due to limited treatment options and inadequate scientific understanding of the disease, many presbyopia patients in China do not receive intervention or vision correction in time. Untreated and escalated, presbyopia adversely impacts vision, quality of work and life, and the psychological well-being of middle-aged and elderly people.

ARVN003 is a proprietary pilocarpine formulation leveraging microdosing platform for the pharmacologic treatment for presbyopia. Pilocarpine ophthalmic solution can constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect, doctors explained.