FDA Approval of AbbVie Eye Drop a New Moment in Presbyopia Treatment
A great leap in Presbyopia treatment with the approval of VUITY.
In a late-day announcement on October 29, AbbVie’s Allergan announced that VUITY, its unique treatment for presbyopia, had received approval from the U.S. Food and Drug Administration. The decision made VUITY the very first and only eye drop to be approved for the presbyopia treatment.
“Most adults cope with presbyopia, or difficulty with near vision, as we age. Beginning around the age of 40, many find themselves using reading glasses, holding text further away, or even increasing the font size and lighting on screens to try to see more clearly,” said AbbVie Vice Chairman and President Dr. Michael Severino, M.D., in the press release. “We are proud to offer VUITY as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia. The FDA approval of VUITY exemplifies our continued pursuit of innovative new treatments that push the boundaries of what's possible in eye care.”
Presbyopia is a common progressive condition that worsens until about the age of 65, apparent only by an increased difficulty focusing on nearby objects. This is caused by the gradual loss of flexibility in the lens, a transparent, proteinaceous tissue that changes shape in order to focus light onto the retina and allows you to discern close-up and far-away objects interchangeably.
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As a result, this condition affects millions of adults over the age of 40. Despite this, the only presbyopia treatment options before now were those mechanical supports in habitual use for similarly poor vision, such as glasses, bifocals, and contact lenses. Now VUITY offers patients a prescription eye drop treatment that temporarily relieves the blurry vision that hallmarks this condition.
Effective as quickly as 15 minutes after application, these eye drops use a specialized formula that combines pilocarpine, an established ocular therapeutic, with Allergan’s propriety pHast technology to deliver relief from blurry vision. During the Phase III GEMINI1 and GEMINI 2 clinical studies of this presbyopia treatment, patients that self-administered VUITY once a day were found to have improved vision for up to six hours on day 30.
“I am particularly encouraged by the rapid onset of action and duration of efficacy for VUITY to improve near and intermediate vision without impacting distance vision with one drop daily, particularly for those with mild to moderate presbyopia,” said Dr. George O. Waring IV, M.D., FACS, the principal study investigator and medical director of the Waring Vision Institute in South Carolina.
Additionally, patients exhibited no serious adverse effects in either study of presbyopia treatment, with the most common side effects being headache and eye redness which occurred in less than 5% of study participants. VUITY was not found to have negatively affected distance vision either during or after use.
This is only the most recent development out of Allergan, an AbbVie company officially acquired in early May of 2020. Just two days earlier, AbbVie reported that Vraylar (cariprazine), another Allergan asset, showed a statistically significant change from baseline to week 6 in major depressive disorder (MDD).