By Dr. Joshua Mali
Allergan, an AbbVie company, announced FDA approval of pilocarpine HCl ophthalmic solution 1.25% (VUITY) for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. According to the company, pilocarpine HCl ophthalmic solution 1.25% 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 US adult population. Pilocarpine HCl ophthalmic solution 1.25% is a daily, prescription eye drop that works in as early as 15 minutes and lasts up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision. Specifically designed for presbyopia, pilocarpine HCl ophthalmic solution 1.25% is an optimized formulation of pilocarpine, an established eye care therapeutic, delivered with pHast technology. The proprietary pHast technology allows pilocarpine HCl ophthalmic solution 1.25% to rapidly adjust to the physiologic pH of the tear film. Pilocarpine HCl ophthalmic solution 1.25% uses the eye’s own ability to reduce pupil size, improving near vision without affecting distance vision.
The FDA approval of VUITY is based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety, and tolerability of VUITY for the treatment of presbyopia. In both studies, the drops met the primary endpoint, reaching statistical significance in improvement in near vision in low light (mesopic) conditions without a loss of distance vision versus the vehicle (placebo) on day 30 at hour 3. Additionally, improvement was seen as early as 15 minutes and lasted through 6 hours. There were no serious adverse events observed in participants receiving VUITY in either the GEMINI 1 or GEMINI 2 study.
VUITY represents a big victory for patients with presbyopia and it is an honor for me as a board-certified ophthalmologist to provide my patients with the most cutting-edge treatments to give them the best vision possible.
Joshua Mali, MD, is a board-certified ophthalmologist and award-winning vitreoretinal surgeon at The Eye Associates, a private multi-specialty ophthalmology practice in Sarasota, Florida. He is the Retina Medical Director of the Macular Degeneration Association (MDA). He is also the Founder & CEO of Mali Enterprises (www.malienterprises.org)