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The first FDA approved eye drop for treating presbyopia

Health
17 Nov 2021

The American Food and Drug Administration approved VUITY recently as a treatment of presbyopia. This eye drop is the first and only FDA-approved treatment of the common and progressive eye condition that affects half of Americans. But what is Presbyopia? And is VUITY eye drops an actual alternative to glasses?

What is Presbyopia?

Presbyopia or age-related blurry near vision is a common eye condition that impacts people above 40, reducing the eye's ability to focus on near objects. In healthy eyes, the clear lens behind your iris can change shape and focus light to the retina, which allows you to see close things easily.

As you age, your clear lens will get hard and won’t be able to change the shape easily, meaning it won’t be easy to focus on near objects anymore. Keep in mind that presbyopia should be diagnosed by an optometrist.

VUITY eye drop as an alternative to glasses

The VUITY new eye drop should be used based on a prescription for people between 40 and 50 years old, it needs about 15 minutes to work and can last up to 6 hours, it improves your near and intermediate vision without impacting the distance vision. So, it could sound like the perfect treatment for presbyopia, but can cause headaches and red-eye when it is used daily. Keep in mind that VUITY is basically an optimized formula of Pilocarpine, which is an eye care therapeutic, delivered by pHast™ technology. This technology is a property of VUITY, it adjusts to the physiologic pH of the tear film quickly. They use your eye's own ability to reduce pupil size, which will improve your near vision without affecting the distance vision.

FDA approved VUITY based on the data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, those studies were done to evaluate the efficacy, safety, and endurance of VUITY to treat presbyopia and were conducted on 750 participants in the ages of 40 to 50. However, VUITY eye drop did meet the primary endpoint, they reach a statistical significance in the improvement of near vision in the low light, without any loss of the distance vision too.

In addition to that, improvement was noticed after the first 15 minutes and lasted about 6 hours. There were no serious adverse reactions in participants who receive VUITY in either GEMINI 1 or GEMINI 2 study. However, the most common adverse reactions were headaches and eye redness, they occurred at a frequency of more than 5%.

Safety Information about FDA approved VUITY eye drop

As we have mentioned, the VUITY eye drop will be used by many people to treat adults’ presbyopia and enhance their quality of life. However, there are some important information that should be taken under consideration before using the new eye drop;

  • It is only suitable for people between 40 and 50 years old, who suffer from presbyopia.
  • It is not a definitive cure for age-related presbyopia and does not replace reading glasses in any way.
  • It causes some side effects for some people, including headache, eye redness, it also affects far vision in low light.
  • The study warned people from night driving and all dangerous activities that take could place in the dim lighting.

 

 In the end, we cannot fully relay on this eye drop, we need more time and studies to ensure VUITY efficiency as mentioned in the preliminary studies.