What is Vuity?
In December 2021, Allergan, an AbbVie company, announced that VUITY™ (pilocarpine HCl ophthalmic solution) 1.25%, the first and only eye drop approved by the U.S. Food and Drug Administration (FDA) to treat presbyopia, is now available by prescription in pharmacies nationwide.
Presbyopia, known as age-related blurry near vision, is a common and progressive eye condition that reduces the eye’s ability to focus on near objects. It begins to impact people beginning at approximately age 40, and slowly gets worse as we age. Before presbyopia occurs, the clear lens behind the iris can change shape and focus light on the retina, making it easier to see things up close. After presbyopia develops, the clear lens hardens and does not change shape as easily, making it difficult to focus on near objects. The mainstay of treatment for presbyopia has been reading glasses. However, there are other options, such as contact lenses, or resorting to work-arounds like zooming in on digital devices or increasing font size to see up close. Presbyopia can be diagnosed by an eye doctor, either an ophthalmologist or optometrist.
VUITY™ is an optimized formulation of pilocarpine, a long-established eye care medication, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHast™ technology, which allows VUITY™ to rapidly adjust to the physiologic pH of the tear film. This was studied in simulated tear film, and the clinical significance is unknown. VUITY™ uses the eye’s own ability to reduce pupil size (i.e., makes the pupil smaller), improving near and intermediate vision while maintaining distance vision.
The FDA approval of VUITY™ in October 2021 was based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety, and tolerability of VUITY™ for the treatment of presbyopia.
- A total of 750 participants aged 40 to 55 years old with presbyopia were randomized in the two studies in a one-to-one ratio to either VUITY™ or placebo.
- Participants were instructed to administer one drop of VUITY™ or placebo once daily in each eye.
- Both studies met their primary endpoints with a statistically significant proportion of participants treated with VUITY™ gaining three lines (the ability to read three additional lines on a reading chart) or more in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA), without losing more than 1 line (5 letters) of Corrected Distance Visual Acuity (CDVA) at day 30, hour 3, versus placebo.
- There were no serious adverse events observed in any participants treated with VUITY in either clinical study. The most common adverse events occurring at a frequency of >5% in participants treated with VUITY™ were headache and eye redness.
What does all this mean practically speaking? Is VUITY™ right for you?
First, I feel it is important to note the age group in which VUITY™ was studied, 40- to 55-year-olds. This is the best age to consider VUITY™ . As noted earlier, presbyopia worsens as we age. For example, someone may need only +1.00 over-the-counter reading glasses at 40. This number can increase to +1.50 by age 45, +1.75 by age 50, and +2.00 or more by age 55-60. VUITY™ will work best in the early stages of presbyopia, and its efficacy will be less in patients in later stages. VUITY™ also will be less likely to help someone who has had standard, monofocal intraocular lenses placed in their eyes after cataract surgery. However, so far, we have found VUITY™ to help improve near vision in people who have had multifocal intraocular lenses placed after cataract surgery and desire sharper near vision.
VUITY™ is taken once daily in each eye. It is not necessary to take it first thing in the morning, and in fact, we recommend taking it 20-30 minutes before you expect to need to see up-close. For example, don’t take it before you shower and leave for work. Take the drop approximately 20-30 minutes before you need to start working. However, you will need to wait 15 minutes after applying VUITY™ to insert your contact lenses.
VUITY™ is available at local pharmacies. It is by prescription only. It is NOT covered by insurance and costs approximately $79 per bottle.
What about side effects? As mentioned previously, the most common side effects in the studies were headache and eye redness. Headache is a well-known side effect of pilocarpine, and you most likely will experience this. It usually responds to acetaminophen (Tylenol) and lessens the more you use the eye drop. Also, as noted above, VUITY™ makes your pupil smaller. This can give a sensation of “dim” vision since less light is transmitted through the pupil.
IMPORTANT SAFETY INFORMATION
- Do not use VUITY™ if you are allergic to any of the ingredients.
- Use caution when driving at night or performing hazardous activities in poor lighting.
- Temporary problems when changing focus between near and distant objects may occur. Do not drive or use machinery if vision is not clear.
- Seek immediate medical care if you experience any sudden vision loss.
- If you wear contact lenses, they should be removed prior to VUITY™ use. Wait 15 minutes after dosing before reinserting contact lenses.
- Do not touch the dropper tip to any surface as this may contaminate the contents.
- If more than one topical eye medication is being used, they must be administered at least 5 minutes apart.
- The most common side effects are headache and eye redness. These are not all the possible side effects of VUITY™ .
Written by Dr. Cristan Arena
*Disclaimer: The information provided in this blog is for educational purposes only, and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always consult a health care professional if you have any medical questions or concerns. Do not disregard advice from a health care professional, or delay contacting one based off what you have read from our website.