FDA Approves First Dual-Agent Eye Drop for Presbyopia
The FDA approved carbachol/brimonidine tartrate ophthalmic solution (Yuvezzi) for adults with presbyopia, marking the first dual-agent eye drop therapy for age-related near-vision decline. Unlike previously approved presbyopia drops that contain a single active ingredient (such as pilocarpine or aceclidine), Yuvezzi combines two agents with distinct mechanisms of action, offering a novel treatment approach.
The FDA approval of YUVEZZI is based on positive data from two Phase 3 studies. The Phase 3 BRIO I study demonstrated a superior benefit of the combination therapy over the individual actives – a requirement for FDA approval of a fixed-dose combination. In the second Phase 3 study, BRIO II, which was vehicle-controlled, YUVEZZI achieved all primary near vision improvement endpoints with statistically significant three-lines or greater improvement in binocular uncorrected near visual acuity (BUNVA) over 8 hours, without the loss of one line or more in binocular uncorrected distance visual acuity (BUDVA). In addition, YUVEZZI was well-tolerated with no treatment-related serious adverse events observed in the more than 72,000 treatment days monitored in BRIO II, the longest safety study (12 months) conducted in presbyopia to-date.2 The most common side effects of YUVEZZI are headache, impaired vision and temporary eye pain or eye irritation.6
Eye redness was not a commonly reported side effect in clinical trials of YUVEZZI. In BRIO I and BRIO II the reports of adverse events of ocular hyperemia (eye redness) were low. In BRIO II, the rate of reported adverse events of ocular hyperemia (eye redness) was lower in subjects receiving YUVEZZI (2.8%) than carbochol alone (10.7%).
“The FDA approval of YUVEZZI represents a significant milestone for the millions of people in the U.S. living with presbyopia and its daily frustrations and challenges,” said Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics. “As the first FDA-approved dual-agent eye drop for presbyopia, YUVEZZI leverages the mechanisms of carbachol and brimonidine tartrate to deliver sharp near vision with favorable tolerability. People deserve treatments that not only work but also can fit conveniently into their daily lives, and YUVEZZI brings an innovative new option to the presbyopia category. This approval marks the first groundbreaking therapy for Tenpoint Therapeutics aimed at advancing our mission to bring innovation to the aging eye.”
“The impact of presbyopia is often underestimated, and current solutions like glasses, contacts or surgery have fallen short in meeting the real-world needs of people who struggle with close-up tasks,” said John Hovanesian, M.D., FACS, of Harvard Eye Associates in Laguna Hills, California. “YUVEZZI introduces a novel approach by combining carbachol and brimonidine tartrate in a single daily eye drop that sharpens near vision and maintains tolerability throughout the day. YUVEZZI was intentionally designed to deliver both efficacy and tolerability, which represents an important step forward in delivering a complete, non-invasive option for people with presbyopia.”
“Presbyopia remains a universal and progressive condition that requires individualized management strategies,” said Mile Brujic, OD, FAAO, of Premier Vision Group in Bowling Green, Ohio. “I’m excited that I will be able to offer my patients YUVEZZI™, the first-of-its-kind eye drop well-suited for long-term use. For people seeking a reliable, lifestyle-friendly solution to manage their near vision challenges in aging eyes, YUVEZZI is a valuable and practical advancement.”
“We’ve been working diligently to bring YUVEZZI to the eye care community and to the millions of adults looking for the optimal solution to address their frustration with presbyopia,” said Carol Kearney, Chief Commercial Officer of Tenpoint Therapeutics. “It was important to us that we provide an option that fits seamlessly into active, social and professional lifestyles, and we intentionally designed YUVEZZI to offer the right balance of efficacy, tolerability and ease of use.”
About Presbyopia
Presbyopia is the gradual loss of near vision that typically begins around age 45 and significantly affects aging eyes and quality of life. It is a natural, inevitable part of aging and impacts nearly 128 million people in the U.S. and ~2 billion people worldwide. Presbyopia affects the lens’ ability to change shape and focus on close objects.9 It can also make it difficult to adapt to different levels of ambient illumination, particularly in dim or low-contrast settings.
