new eye drops improve vision without glasses or surgery

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Presbyopia, or age-related blurred near vision, is a common and progressive condition that reduces the eye’s ability to focus on nearby objects, affecting most adults over the age of 45. Recently, Allergan, a subsidiary of AbbVie, announced that the US Food and Drug Administration (FDA) has approved the use of the first eye drops, called VUITY, that can compensate for presbyopia — without glasses or corrective lenses. explanation.

Presbyopia affects more than a billion people worldwide. In a non-presbyopic eye, the lens behind the iris (the lens) can easily change shape and focus light on the retina, allowing clear vision both near and far. In a presbyopic eye, the lens hardens and doesn’t change shape as easily, making it difficult to focus on nearby objects. Presbyopia can be diagnosed by an ophthalmologist or optician. The usual “treatment” is the use of glasses, contact lenses, or eye surgery.

In a statement, Michael Severino, president of AbbVie, said: Most adults, as we age, deal with presbyopia or problems with near vision. From around 40, many find themselves using reading glasses, holding text further away, or even increasing the font size and lighting of screens to try to see more clearly. So with this technology, many people would be able to compensate for their presbyopia in a much simpler way. But how does it work?

1 drop of eye drops = 6 to 10 hours of effect

VUITY is touted as the first FDA-approved treatment for presbyopia. It is available by prescription from an ophthalmologist or optometrist in U.S. pharmacies. These eye drops are formulated with pilocarpine (a substance already used in the treatment of glaucoma) and use a technology developed by Allergan to adapt to the pH of the tear film (pHast™). It uses the eye’s own ability to reduce pupil size, improving near and intermediate vision while preserving distance vision.

Bottle of VUITY eye drops. © ALLERGAN

Indeed, it must be known that to produce a clear image, the eyes must adapt to the distance of an object through three phases, if it is close. First the eyes point at the object, then the lens changes shape and the pupils contract. The pupillary reshaping is performed by small eye muscles that contract to make the lens thicker (nearsightedness). Indeed, the thicker the lens, the more the light is refracted during its passage. At the same time, the pupils constrict to block some of the incoming light from other distant objects. When light bounces off an object and enters the eye, the rays of light in the center provide a clear image. Blocking scattered light by constricting the pupil sharpens the image of nearby objects.

Jag Dosanjh, Senior Vice President of Medical Therapeutics at Allergan, explains: We’re excited to bring this first-of-its-kind treatment to market faster than expected for the millions of presbyopic Americans who could benefit from it. This significant innovation in age-related eye health reflects our commitment to improving eye care and expands our portfolio of leading edge treatments for eye care providers and their patients.

The VUITY Clinical Development Program

VUITY’s FDA approval in October 2021 is based on data from two pivotal Phase 3 clinical studies, GEMINI 1 and GEMINI 2, that evaluated the efficacy, safety and tolerability of VUITY for the treatment of presbyopia. A total of 750 participants with presbyopia, ages 40 to 55, were randomly assigned to two separate groups, one receiving VUITY and the other a placebo. The participants were required to administer one drop of VUITY or placebo in each eye once a day.

The results showed that after 30 days, patients treated with VUITY were able to read at least three additional lines at close range on a typical reading chart, compared to those treated with placebo. And this without losing more than one line of sight in the distance. The eye drops work in 15 minutes and for a duration of 6 to 10 hours. No serious side effects were observed. Allergan lists 5% as non-serious side effects, mostly headache and red eyes. The lab specifies that these drops should be used with caution when driving at night and when performing hazardous activities in low-light conditions.

Presbyopia in the future

VUITY is currently approved for once-daily use. But recently, Allergan announced that the Phase 3 VIRGO trial, which evaluated the safety and efficacy of experimental twice-daily administration of VUITY, met its primary efficacy endpoint of improving near vision without compromising distance vision. bring. The same testing protocol was used (two randomized groups receiving either eye drops or placebo). Specifically, the researchers found that patients treated with VUITY were able to read at least three additional lines up close on the typical reading chart in just 14 days. Additional details of this trial will be presented at future medical meetings and will form the basis for an additional submission of a new drug application for elective twice daily dosing to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022.

Christopher Lievens, a study participant and professor at the Southern College of Optometry in Memphis, said in a statement: We are encouraged by the results of the VIRGO study, which suggest that taking VUITY twice daily may provide an additional dosing option for people with presbyopia to improve their near vision without compromising their distance vision.

Finally, VUITY is not a miracle treatment, because the effect is only temporary. We can’t do without reading glasses or progressive lenses with these eye drops, but they illustrate the trend of current medical research: finding the most comfortable and least invasive treatments possible.

Source: AbbVie

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