USA – The US Food and Drug Administration (US FDA) has approved the first eye drop to improve age-related near-vision, reports Express.co.uk.
The drug is called Vuity, which is comprised of 1.25 percent pilocarpine HCL ophthalmic solution made by AbbVie-owned Allergan. With the approval, Vuity becomes the first eyedrop approved for presbyopia.
As per an Express.co.uk report, the eye drops need to be applied once every six hours and starts working within 15 minutes of application.
According to the report, the medication is a formulated form of the well-known compound known as pilocarpine, and the researchers have developed it to quickly adapt to the pH of the tear film.
Utilizing the eye’s natural ability to constrict the pupil, the drop enhances near vision while preserving far vision.
Presbyopia is a common eye condition that begins around the age of 40 and progressively worsens until the age of 65 or so.
The addition of Vuity to the treatment armamentarium for presbyopia is only the beginning of a significant change.
It is characterized by difficulties in focusing on nearby objects, which is caused by a loss of flexibility in the lens of the eye.
The flexibility of the eye lens allows it to change shape to focus light onto the retina; with age, this elasticity is lost.
The eye drop is most helpful for people between the ages of 40 and 55, according to the researchers’ analysis of two randomized control trials involving 750 participants.
Clinical trial results of the eye drops
Results have come from two randomized control trials on 750 subjects with presbyopia, aged 40 to 55 years old. Half of the participants got the new eye drops, while the others got placebo eye drops.
The participants put one eye drop of Vuity or a placebo in each eye, once a day. The medicine began to show positive effects in about 15 minutes, with a sharper vision lasting for around 6-10 hours.
In a positive piece of news, the researchers reported no serious side effects in either of the clinical studies.
However, some patients experienced mild headaches and eye redness. People may also have temporary challenges in adjusting their focus due to eye drops use.
However, the effect of the drug wears off, which might make a two-drop per day option ideal for some patients.
Medical news website Healio.com reports that AbbVie/Allergan has successfully completed trials for a twice-daily Vuity dosing regimen.
The addition of Vuity to the treatment armamentarium for presbyopia is only the beginning of a significant change.
The pipeline consists of several other presbyopia-correcting drops, and while they all work similarly, certain drops may work better for specific patients.
Another two-drop daily option is in the pipeline: CSF-1 (pilocarpine hydrochloride 0.4%, Orasis Pharmaceuticals). Like Vuity, CSF-1 is a miotic that exploits the pinhole effect to increase depth and vision.
However, none of the drops are one size fits all, and it is too early to tell, but they may not be effective indefinitely.
The innovative new eye treatment from AbbVie faces competition in the market. New York biotech Eyenovia announced positive trial results for its drug-device combo called MicroLine for the treatment of presbyopia.
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