June 26, 2022

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FDA approved the first eye drops to treat presbyopia

FDA approved the first eye drops to treat presbyopia



FDA approved the first eye drops to treat presbyopia. It works in 15 minutes and lasts for 6 hours! 

On October 31, AbbVie announced that the U.S. FDA has approved its Allergan company’s Vuity (Pilocarpine 1.25% ophthalmic solution) to be marketed for the treatment of presbyopia. The press release states that this is the first eye drop therapy approved by the FDA for the treatment of presbyopia.

presbyopia

Presbyopia affects nearly 2 billion people worldwide, and there are currently no effective drug solutions available for patients. Now, patients can only choose to wear reading glasses, which is inconvenient for many patients. And receiving irreversible invasive surgery has inherent risks associated with surgery. Therefore, patients have a keen interest in an effective and safe treatment for presbyopia.

Vuity is an innovative and optimized ophthalmic formula of pilocarpine. Its main mec

hanism of action is to constrict the pupils, thereby enhancing the depth of field and improving near vision and intermediate vision. At the same time, the pupils should respond normally to different lighting conditions.

Image source: 123RF

This approval is supported by data from two pivotal Phase 3 clinical trials involving approximately 750 patients. The data showed that on the 30th day of treatment, compared with placebo, patients treated with Vuity were able to obtain indicators of near vision testing.

Significant improvement, at the same time this eye drops will not affect the patient’s distance vision. It takes effect as soon as 15 minutes after instillation, and the effect can last for 6 hours.

In terms of safety, no serious adverse reactions related to treatment were found. The most common adverse events were headache and red eye. Most adverse reactions were mild and temporary. 1.2% of patients discontinued treatment due to adverse events.

“Most adults need to cope with presbyopia as they get older. Starting from about 40 years old, many of us need reading glasses, or place the text to be read far away, or even increase the font size to make it clearer. Read what’s on the screen.” AbbVie President Dr. Michael Severino said, “We are happy to provide Vuity, a unique once-a-day eye drops. We believe it will change the way people and ophthalmologists treat presbyopia .”

Reference:

[1] NDA APPROVAL. Retrieved October 29, 2021, from https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214028Orig1s000ltr.pdf

[2] New Data Presented on the Safety and Efficacy of Investigational AGN-190584 as a Potential Novel Treatment for Presbyopia, a Common and Progressive Eye Condition. Retrieved July 25, 2021, from https://www.prnewswire.com/news-releases/new-data-presented-on-the-safety-and-efficacy-of-investigational-agn-190584-as-a-potential-novel-treatment-for-presbyopia-a-common-and-progressive-eye-condition-301339937.html

[3] U.S. Food and Drug Administration Approves VUITY™ (pilocarpine HCI ophthalmic solution) 1.25%, the First and Only Eye Drop to Treat Presbyopia (Age-Related Blurry Near Vision). Retrieved October 29, 2021, from https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-vuity-pilocarpine-hci-ophthalmic-solution-1-25-the-first-and-only-eye-drop-to-treat-presbyopia-age-related-blurry-near-vision-301412259.html

FDA approved the first eye drops to treat presbyopia.

(source:internet, reference only)


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