FDA Approves AbbVie's Vuity (Pilocarpine 1.25%) as First-Ever Eye Drop for Presbyopia: Onset in 15 Minutes, Lasting Up to 6 Hours

October 30, 2021 /BioonBIOON/ --Recently, the U.S. Food and Drug Administration (FDA) approved AbbVie's subsidiary Allergan's ophthalmic drugVuity (pilocarpine, pilocarpine, 1.25% ophthalmic solution), development code: AGN-190584)Presbyopia Treatment(presbyopia), also known asAge-Related Hyperopia（age-related farsightedness）。

It is worth noting that,Vuity is the first eye drop specifically indicated for the treatment of presbyopia.。FDAVuity was approved based on data from two Phase 3 studies (GEMINI 1 and GEMINI 2). These two studies enrolled a total of 750 patients with presbyopia. Results showed that Vuity met the primary endpoint in both studies:Statistically significant improvement in near vision, with distance vision unaffected.

In July this year, Allergan presented the full results of the Phase 3 GEMINI 1 clinical study at the 2021 Annual Meeting of the American Society of Cataract and Refractive Surgery (ASCRS). The data demonstrated that the study met its primary and key secondary efficacy endpoints: patients receiving once-daily Vuity treatment showed improved near and intermediate vision, with distance vision remaining unaffected.Following administration of Vuity, rapid onset of action and sustained visual improvement lasting up to 6 hours are observed.

Patient-reported outcomes presented at the meeting showed that during the final 7 days of the trial, compared with the placebo group, patients in the Vuity treatment group experienced greater improvements of both clinical and statistical significance in near reading ability and satisfaction, along with a reduction in the use of presbyopia coping mechanisms. The positive findings of this study,Supports the potential of Vuity as a first-line treatment option for patients with presbyopia.

Chemical structure of pilocarpine (Image source: Wikimedia)

Presbyopia is a common, progressive eye condition that impairs the eye's ability to focus on near objects, affecting the majority of adults over the age of 40. In the United States, presbyopia affects nearly half of the adult population. Presbyopia is caused by the loss of the eye's ability to focus on nearby objects. In non-presbyopic eyes, the transparent lens behind the iris can change shape to focus light onto the retina, making it easier to see objects up close. In presbyopic eyes, the transparent lens hardens and loses its flexibility, making it difficult to focus on nearby objects.

Vuity (pilocarpine) is pilocarpine (Muscarinic receptor agonist) a new optimized formulation, specifically designed to treat presbyopia. ItsThe primary mechanism of action is to enhance depth of focus through pupillary constriction, improving near and intermediate vision while maintaining the pupil's response to varying lighting conditions; this effect is known as dynamic pupillary modulation.

Vuity is an ophthalmic solution indicated for the treatment of presbyopia. As a topical medication, it is administered as one drop in each eye once daily. Following instillation, it takes effect within 15 minutes and provides a sustained therapeutic effect, enabling patients to read without the need for reading glasses.It should be noted that Vuity does not completely cure presbyopia, but it can alleviate its symptoms. The drug does not act on the lens; instead, it constricts the pupil, producing a pinhole effect that increases the depth of focus.

Presbyopia-Eye Drops (Image source: ezcontacts.com)

The GEMINI 1 study enrolled a total of 323 patients with presbyopia, who were randomized in a 1:1 ratio to receive Vuity or placebo (drug-free eye drops) instilled in both eyes once daily for 30 days.

The study met the primary and key secondary endpoints: at 3 hours (22.5%, p<0.0001) and 6 hours (9.7%, p=0.0114) on Day 30,Compared with the placebo group, a statistically significantly higher proportion of patients in the Vuity treatment group achieved an improvement of 3 lines or more in mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA) (ability to read three additional lines on a visual acuity chart).

The results also showed that: following administration on Day 30,Vuity demonstrated a rapid onset of 15 minutes and a duration of up to 6 hours in low-light DCNVA, without compromising distance vision.. Other evaluated endpoints showed that 75% of patients in the Vuity treatment group achieved an improvement of ≥2 lines in low-light DCNVA, and 93% of patients achieved ≥20/40 vision in photopic (daylight) DCNVA. On Day 30, improvements in distance-corrected intermediate visual acuity (DCIVA) lasting up to 10 hours were also observed.

In this study, no treatment-emergent serious adverse events were observed in any patient receiving Vuity. The most common treatment-emergent non-serious adverse event (>5%) in the Vuity treatment group was headache. Most side effects were mild and transient, and only 1.2% of patients discontinued treatment due to adverse events. (Bioon.com)

Original Source:FDA approves Abbvie's Vuity eye drops for age-related farsightedness