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 blurred near vision, in adults.
According to the company, Pilocarpine HCl Ophthalmic Solution 1.25% is the first and only FDA-approved eye drop for the treatment of this common and progressive eye condition that affects 128 million Americans, nearly half of the US adult population.
Michael Severino, MD, vice chairman and president of AbbVie, noted that most adults who have presbyopia, or near vision problems, get better as they get older.
“By about the age of 40, many wear reading glasses, hold text farther away, or even increase the font size and lighting on screens to see more clearly,” he said in a statement. “We are proud to offer VUITY is the first once-daily eye drop of its kind, which we believe will transform the way people and their eye care professionals approach presbyopia in eye care.”
Pilocarpine HCl Eye Drops 1.25% are prescription-only, daily-use eye drops that work in as little as 15 minutes and last up to 6 hours as measured on day 30 to improve near and intermediate vision without affecting distance vision .
Developed specifically for presbyopia, Pilocarpine HCl Ophthalmic Solution 1.25% is an optimized formulation of Pilocarpine, an established ophthalmic drug delivered with PHast technology. Proprietary pHast technology allows Pilocarpine HCl Ophthalmic Solution 1.25% to rapidly adjust to the physiological pH of the tear film. Pilocarpine HCl Ophthalmic Solution 1.25% harnesses the eye’s 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 novel, safe, well-tolerated and effective alternative to current options for treating age-related blurred near vision. said George O. Waring IV, MD, FACS, medical director, Waring Vision Institute, South Carolina, and principal investigator of the GEMINI 1 and GEMINI 2 studies. “I am particularly encouraged by the rapid onset and longevity of VUITY’s effectiveness to improve near and intermediate vision with one drop daily without compromising distance vision, particularly in those with mild to moderate presbyopia.”
The FDA approval of VUITY is based on data from two pivotal phase 3 clinical trials, 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 in improvement in near vision in low light conditions (mesopic) with no loss in distance vision versus vehicle (placebo) at day 30 at hour 3. Also, improvement was observed as early as 15 minutes and lasted 6 hours. No serious adverse events were observed in participants who received VUITY in either the GEMINI 1 or GEMINI 2 studies. The most common side effects, occurring with a frequency of > 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 enrolled in the two studies in a one-to-one ratio of placebo to pilocarpine HCl ophthalmic solution 1.25 % randomized.
According to the company, study participants were instructed to inject one drop of VUITY or placebo in each eye once daily.
Both studies met their primary endpoints, with a statistically significant proportion of VUITY-treated participants gaining three lines (the ability to read three additional lines on a reading chart) or more in mesopic (in low light), high-contrast, binocular distance-corrected near vision Visual acuity (DCNVA) without losing more than 1 line (5 letters) of corrected distance visual acuity (CDVA) at Day 30, Hour 3 compared to placebo.
No serious adverse reactions were observed in any of the clinical studies in participants treated with pilocarpine HCl ophthalmic solution 1.25% VUITY. The most common treatment-emergent non-serious adverse events, occurring with a frequency of > 5% in participants treated with pilocarpine HCl ophthalmic solution 1.25%, were headache and erythema.