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Vuity (pilocarpine) approved by FDA for presbyopia

Vuity has become the first treatment approved by the FDA for the treatment of presbyopia, the aged-related blurry near vision, according to a press release from the manufacturer, Allergan, a subsidiary of Abbvie. Presbyopia is the gradual loss of the eye’s ability to focus on nearby objects and thus represents a natural part of the ageing process. Studies suggest that in 2015, globally, there were 1.8 billion people with presbyopia with some 826 million of whom had near vision impairment because they had no, or inadequate, vision correction.

According to the press release, Vuity is a daily, prescription eye drop that contains pilocarpine 1.25% and which starts to work within 15 minutes and creates an effect that can last for up to 6 hours. Vuity is an optimised formulation of pilocarpine, delivered via a patented technology which allows Vuity to rapidly adjust to the physiologic pH of the tear film. The formulation then uses the eye’s own ability to reduce pupil size, improving near vision without affecting distance vision.

Clinical efficacy

Data on the efficacy of vuity comes from two phase III trials, GEMINI 1 and 2. Together, the trials randomised a total of 750 patients, aged 40 – 55 years old with presbyopia, in a 1:1 ratio to either vuity or placebo which was administered bilaterally, once daily for 30 days. The results of the two studies were presented in terms of the proportion of patients achieving a distance-corrected intermediate visual acuity (DCIVA) at several time points after 30 days of treatment.

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In a poster presentation, after 3 hours on day 30, the percentage of participants who achieved functional vision of 20/40 or better in photopic, high-contrast, binocular DCNVA was 75.2% (placebo) and 87.6% (vuity) which was statistically significant (p<0.0001). Moreover, the differences compared to placebo were significant at all of the time-points assessed. Overall, a greater proportion of presbyopia patients (31 % in Gemini I and 26% in Gemini 2) given vuity were able to read three additional lines on a reading chart three hours after treatment at day 30 compared with vehicle placebo (8% and 11% Gemini 1 and Gemini 2 respectively). 

In terms of safety, the company reported that there were no serious adverse events observed in any participants with the most common treatment emergent non-serious adverse events occurring at a frequency of >5% in participants were headache and eye redness.

Source. Abbvie news centre, October 29, 2021

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