In key win, AbbVie lands FDA approval for Allergan's blurred-vision eye drop
AbbVie’s age-related blurry vision drug for aging adults was given the OK by the FDA Friday, making it the first eye drop to treat an eye condition that affects 128 million Americans.
Formerly AGN-190584, the drug has proven a bright spot in Allergan’s pipeline since AbbVie bought it out for $63 billion, which has seen more setbacks than wins.
The daily prescription eye drop is approved to treat presbyopia. Vuity is a formulation of pilocarpine, a well-known drug for intraocular pressure and various types of glaucoma, among other uses. Allergan had deployed a different delivery method that promised to make the drug better tolerated.
“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,” said Michael Severino, president of AbbVie.
The approval means that the targeted timeline has been met, as AbbVie aimed for an approval before New Year’s. In July, the company offered a close-up of its data. The Phase III study dubbed Gemini I offered proof that the eyedrops deliver fast though transient improvements in reading ability, with a statistically significant group of patients adding three lines or more when viewing a reading chart.
More data showed that 75% of participants achieved at least a two-line improvement, and 90% of participants achieved 20/40 vision. Often, adults cope with blurred vision that comes along with aging by using reading glasses or increasing font size on screens and the lighting in rooms. Vuity is seen as an alternative to those and surgical options.
The program was originally part of Allergan’s pipeline until it was acquired by Abbvie in a $63 billion buyout. That deal was largely centered around the $16 billion Botox franchise, and the company has slowly ended other R&D projects over time.
In two Phase III studies, Gemini 1 and Gemini 2, 750 participants between the ages of 40 and 65 were instructed to administer one drop of Vuity or a placebo into their eyes once a day. No serious side effects were reported.
“As we age, the lenses of our eyes become less flexible, making it more difficult to focus on things up close. VUITY offers a novel, safe, well-tolerated and effective alternative to current options for managing age-related blurry near vision,” George Waring IV, the medical director at the Waring Vision Institute and principal study investigator, said in a press release. “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.”