The U.S. Food and Drug Administration (FDA) has agreed to review a new application from the pharmaceutical company Viatris, according to MedPath.
The application seeks to expand the use of the eye drop phentolamine 0.75 percent for the treatment of presbyopia, also known as age-related vision.
The FDA is expected to make a final decision by October 17, 2026.
The medication is already sold in the United States under the name Ryzumvi, but it is currently approved only for the treatment of pharmacologically induced pupil dilation.
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Results from trials
The application is based on two large clinical trials, VEGA-2 and VEGA-3.
According to Viatris, both studies met their primary endpoints, and no serious side effects related to the treatment were observed.
The most common side effects were mild eye discomfort upon instillation, redness, and altered taste.
The treatment should not be used in cases of active eye inflammation. Contact lenses must be removed before use and may be reinserted after 10 minutes.
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Many affected
Presbyopia is a natural part of aging and means that the eye gradually has more difficulty focusing on objects up close.
Around the age of 50, most people require reading glasses or other forms of vision correction.
Globally, an estimated 1.8 billion people had presbyopia in 2015. The figure is expected to rise to 2.1 billion by 2030.
Sources: MedPath.
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This article is made and published by Ida-Marie Palm Varbæk, who may have used AI in the preparation.