For Immediate Release
Allergan, an AbbVie company announced the U.S. Food and Drug Administration (FDA) has approved VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. Allergan states “VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population.”
Michael Severino, M.D., vice chairman and president, AbbVie said “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.”
John C. Meyer, MD, of The Eye Care Institute and Butchertown Clinical Trials, who acted as Principal Investigator in the clinical trials, stated “presbyopia is often noticed by persons, usually over 40, who suddenly notice they need longer arms. Holding your phone or paperwork further away is a simple, but short-lived, step to help with near and intermediate vision. The FDA approval of this eye drop allows people another option in how they choose to work with their eye doctor to improve their own vision. This is the first eye drop to correct near and intermediate vision without changing distance vision.”
This is the 15th FDA-approved drug or device for Louisville, KY-based Butchertown Clinical Trials, a division of The Eye Care Institute. The 13th and 14th FDA approvals were announced within the past two weeks. Mark Prussian, CEO, stated having an eye drop option to correct near and intermediate vision is a breakthrough treatment option for patients. This FDA approval also marks a milestone for the evolution of our clinical trials center. Specifically, this is the first time our clinical trials center has participated in the entire clinical trials process, including Phase 1, Phase 2, and Phase 3 clinical trials. Our patient participation, commitment to the scientific method, excellence in data documentation, and our outstanding clinical trials team are evident throughout all three phases of the clinical trials process for Vuity™ and in its ultimate approval by the FDA, affect every part of this FDA approval.
# # #
For More Information Contact Mark Prussian at Butchertown Clinical Trials