FDA approves eye drops for presbyopia
The US Food and Drug Administration has confirmed that Allergan’s Vuity eye drops can be used to treat age-related difficulties with near vision
The US Food and Drug Administration has approved an eye drop for the treatment of presbyopia.
A 1.25% pilocarpine HCl ophthalmic solution, named Vuity, is the first eye drop to receive FDA approval for this application.
Phase three clinical studies involving the Allergan product showed that the eye drop improved near and intermediate vision without affecting distance vision.
The effects of the eye drop could be seen after 15 minutes and lasted for up to six hours.
Vice chairman and president of Allergan’s parent company, AbbVie, Michael Severino, shared: “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."
Phase two and three clinical studies testing the eye drop involved 750 participants between the ages of 40 and 55.
Participants were randomly assigned either a placebo eye drop or Vuity to instil one drop in each eye once a day.
Those assigned Vuity were able to read an average of three additional lines on a reading chart in comparison with those assigned the placebo eye drop.