FDA approves eye drops for the treatment of presbyopia
Allergan, an AbbVie company, announced the FDA approval of pilocarpine HCl 1.25% ophthalmic solution (VUITY) for the treatment of presbyopia, commonly known as age-related blurred near vision, in the adults.
According to the company, 1.25% pilocarpine HCl ophthalmic solution is the first and only eye drops approved by the FDA to treat this common and progressive eye condition that affects 128 million Americans, or nearly half of the adult population. American.
Michael Severino, MD, vice president and president of AbbVie, noted that most adults face presbyopia, or near vision difficulties, as they age.
“From around 40 years of age, many find themselves using reading glasses, holding text away, or even increasing the font size and lighting on screens to try and see more clearly,” he said. he said in a press release. “We are proud to offer VUITY as a unique once-daily eye drop that we believe will change the way people and their ophthalmologists approach presbyopia. The FDA approval of VUITY illustrates our pursuit. continues to deliver innovative new treatments that push the boundaries of what is possible in eye care.
Pilocarpine HCl 1.25% Ophthalmic Solution is a daily prescription eye drop that works as early as 15 minutes and lasts up to 6 hours, as measured on day 30, to improve near and intermediate vision without affecting distance vision.
Specially designed for presbyopia, 1.25% Pilocarpine HCl Ophthalmic Solution is an optimized formulation of pilocarpine, an established eye therapy product, delivered with pHast technology. Proprietary pHast technology allows 1.25% Pilocarpine HCl ophthalmic solution to quickly adjust to the physiological pH of the tear film. Pilocarpine HCl 1.25% ophthalmic solution utilizes the eye’s own ability to reduce pupil size, improving near vision without affecting distance vision.
“As we age, the lenses in our eyes become less flexible, making it harder to focus on things up close. VUITY offers a new, safe, well-tolerated and effective alternative to current options for managing age-related blurred near vision, “said George O. Waring IV, MD, FACS, Medical Director, Waring Vision Institute, North Carolina Sud, and principal investigator of the GEMINI 1 and GEMINI 2 study. “I am particularly encouraged by the rapid onset of action and the duration of effectiveness of VUITY to improve near and intermediate vision without affecting distance vision with one drop per day, especially for people with mild to moderate presbyopia. “
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, achieving statistical significance for improving near vision in low light conditions (mesopes) without loss of distance vision compared to vehicle (placebo ) on day 30 at hour 3. In addition, an improvement was observed. as early as 15 minutes and lasted up to 6 hours. No serious adverse events were observed in participants receiving VUITY in the GEMINI 1 or GEMINI 2 studies. The most common adverse events occurring at a frequency> 5% were headache and eye redness.
In the phase 3 clinical studies GEMNI 1 and GEMINI 2, a total of 750 participants aged 40 to 55 years with presbyopia were randomized in the two studies in a one-to-one ratio between placebo and hydrochloride ophthalmic solution. 1.25% pilocarpine.
According to the company, study participants were instructed to give one drop of VUITY or a placebo once a day to each eye.
Both studies met their primary endpoints with a statistically significant proportion of participants treated with VUITY gaining three lines (the ability to read three additional lines on a reading board) or more in mesopic (low light), high contrast , corrected near visual binocular distance (DCNVA), without losing more than one line (5 letters) of corrected distance visual acuity (CDVA) on day 30, hour 3, versus placebo.
No serious adverse events were observed in participants treated with VUITY Pilocarpine Hydrochloride Ophthalmic Solution 1.25% in any of the clinical studies. Non-serious adverse events occurring during treatment at a frequency> 5% in participants treated with pilocarpine HCl 1.25% ophthalmic solution were headache and redness of the eyes.