AbbVie Launches VUITY (pilocarpine 1.25% ophthalmic solution), the First and Only FDA-Approved Eye Drop for Presbyopia, Now Available in the U.S.

December 12, 2021 /BioValleyBIOON/ -- AbbVie Inc.'s subsidiary Allergan plc recently announced the launch of a new ophthalmology drug in the U.S. market.Vuity (pilocarpine, 1.25% ophthalmic solution), This medicine is used for the treatment ofPresbyopia, also known asAge-related near vision blur。

Presbyopia can be diagnosed by an ophthalmologist through a basic eye examination.DiagnosisPresbyopia, a common progressive eye condition, reduces the eye's ability to focus on nearby objects. In the United States, presbyopia affects 128 million people, or nearly half of the adult population, typically adults over the age of 40.

In October 2021, Vuity was approved by the United StatesFDAApproval,Is the first and only eye drop specifically designed to treat presbyopia.Vuity is a once-daily prescription eye drop.Can improve near and intermediate vision without affecting distance visionPhase 3 clinical data shows that after Vuity is dripped into the eyes,Takes effect in 15 minutes, with effects lasting up to 6 hours.。

Allergan Senior Vice President of Medical Treatments, Jag Dosanjh, stated: "We are thrilled to bring this first-of-its-kind treatment to market faster than anticipated, benefiting millions of patients with presbyopia. This significant innovation in age-related eye health reflects our commitment to advancing vision care and expanding our leading portfolio of treatments for eye care providers and their patients."

Chemical structure of pilocarpine (Image source: Wikimedia)

Presbyopia is a common, progressive eye condition that reduces the eye's ability to focus on nearby objects, affecting most adults over the age of 40. In the United States, presbyopia affects nearly half of the adult population. Presbyopia is caused by the eye's loss of ability to focus on close objects. In non-presbyopic eyes, the clear lens behind the iris can change shape to focus light onto the retina, making it easier to see things up close. In presbyopic eyes, the clear lens becomes hardened and less able to change shape, making it difficult to focus on nearby objects.

Vuity (pilocarpine) isPilocarpine (M-Cholinergic Receptor Agonist)A new optimized formula specifically designed for the treatment of presbyopia. ItsThe main mechanism of action is to enhance the depth of focus by contracting the pupil, improving near and intermediate vision while maintaining the pupil's response to different lighting conditions, an effect known as dynamic pupil modulation.。

Vuity is an eye drop used to treat presbyopia, administered as an external medication once daily in both eyes. It takes effect within 15 minutes after application and provides long-lasting results, allowing patients to read without glasses. It should be noted that,Vuity cannot completely cure presbyopia, but it can alleviate its symptoms. The drug does not act on the lens but constricts the pupil, creating a pinhole effect that increases the depth of focus.

Presbyopia-Eyedrops (Image Source: ezcontacts.com)

United StatesFDAApproval of Vuity was based on data from two Phase 3 studies (GEMINI 1, GEMINI 2). These two studies enrolled a total of 750 patients with presbyopia aged between 40 and 55 years. The patients were randomly assigned in a 1:1 ratio to receive either Vuity or a placebo (drug-free eye drops) administered to both eyes once daily for 30 days.

The results showed,Both studies met the primary endpoint: Patients receiving Vuity treatment once daily experienced improved near and intermediate vision without affecting their distance vision. Vuity took effect quickly and provided sustained visual improvement for up to 6 hours after administration.

Specifically, on Day 30 of treatment, three hours after eye drop administration, a statistically significantly higher proportion of patients in the Vuity treatment group compared to the placebo group achieved a gain of three or more lines (the ability to read three additional lines on a reading chart) with no more than one line (five letters) of vision loss under low light, high contrast, and binocular distance-corrected near visual acuity (DCNVA). In both studies, no serious adverse events were observed in the Vuity treatment group. The most common adverse events with an incidence rate greater than 5% were headache and eye redness. (Bioon.com)

Source of Original Text:VUITY (pilocarpine HCI ophthalmic solution) 1.25%, the First and Only FDA-Approved Eye Drop to Treat Age-Related Blurry Near Vision (Presbyopia), is Now Available