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- FDA approves eye drops for presbyopia
FDA approves eye drops for presbyopia
The US Food and Drug Administration has confirmed that Allergan’s Vuity eye drops can be used to treat age-related difficulties with near vision
27 November 2021
The US Food and Drug Administration has approved an eye drop for the treatment of presbyopia.
A 1.25% pilocarpine HCl ophthalmic solution, named Vuity, is the first eye drop to receive FDA approval for this application.
Phase three clinical studies involving the Allergan product showed that the eye drop improved near and intermediate vision without affecting distance vision.
The effects of the eye drop could be seen after 15 minutes and lasted for up to six hours.
Vice chairman and president of Allergan’s parent company, AbbVie, Michael Severino, shared: “We are proud to offer Vuity as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia. The FDA approval of Vuity exemplifies our continued pursuit of innovative new treatments that push the boundaries of what's possible in eye care."
Phase two and three clinical studies testing the eye drop involved 750 participants between the ages of 40 and 55.
Participants were randomly assigned either a placebo eye drop or Vuity to instil one drop in each eye once a day.
Those assigned Vuity were able to read an average of three additional lines on a reading chart in comparison with those assigned the placebo eye drop.
Comments (3)
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IkeE17 March 2022
I suspect this will go the way of Latisse: full availability to most Optometrists in the United States, limited or no accessibility to most UK Optometrists.
Given the prescribing information (1), in the unlikely event NICE and the other relevant UK authorities authorize this drug, it will almost certainly be a POM (Prescription Only Medicine)
Reference.
(1) AbbVie Inc. Vuity ,Full Prescribing Information. https://www.rxabbvie.com/pdf/vuity_pi.pdf Retrieved April 16 2022
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Nicholas Rumney25 December 2021
Anyone old enough to remember the deprivations glaucoma treatment with pilo caused will be cynical about this. It might just help low presbyopes who don’t drive at night but the importance of a mobile pupil cannot be underestimated in optimising contrast sensitivity to retinal adaptation to luminance. See original papers in Vision Research by Woodhouse.
https://www.sciencedirect.com/science/article/abs/pii/0042698975902783
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Karen7914 December 2021
Will they be POS, P or OTC?
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