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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong> <\/p>\nBack to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\nKey takeaways:<\/h2>\n\nThe dual-agent ophthalmic solution significantly improves presbyopia for up to 10 hours.<\/li>\n It is expected to be available in the U.S. in the second quarter.<\/li>\n<\/ul>\nThe FDA approved Yuvezzi, an eye drop for the treatment of presbyopia, with broad U.S. availability expected in the second quarter, according to a press release from Tenpoint Therapeutics.<\/p>\n
Yuvezzi (carbachol 2.75%\/brimonidine tartrate 0.1% ophthalmic solution), formerly known as Brimochol PF, achieves effect after around 30 minutes and lasts for up to 10 hours, according to Tenpoint. It is the first dual-agent eye drop approved for the treatment of presbyopia and the fourth topical treatment approved overall, following Vuity (pilocarpine HCl ophthalmic solution 1.25%, AbbVie), Qlosi (pilocarpine hydrochloride ophthalmic solution 0.4%, Orasis Pharmaceuticals) and Vizz (aceclidine ophthalmic solution 1.44%, Lenz Therapeutics).<\/p>\n
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\u201cThe impact and daily challenges of living with presbyopia cannot be overstated,\u201d John A. Hovanesian, MD, FACS,<\/b> of Harvard Eye Associates in California, told Healio. \u201cThe unique dual-agent presbyopia drop Yuvezzi, which delivers both on durability and tolerability in a once-daily treatment, promises to be an effective solution for active presbyopes looking for a seamless way to see clearly while performing close-up tasks.\u201d <\/p>\n
Yuvezzi is designed to create a pinhole effect through pupillary constriction, temporarily improving near visual acuity and depth of focus, according to Tenpoint. Carbachol constricts the iris sphincter and ciliary body, while brimonidine tartrate \u201cblocks contraction of the iris dilator muscle and relaxes tonic contraction of the ciliary muscle, enhancing selectivity for the pupil and increasing bioavailability of carbachol in the aqueous humor,\u201d according to the release.<\/p>\n
The approval was based on two phase 3 trials, BRIO-I and BRIO-II, according to the release. Results from BRIO-I supported combining the active ingredients vs. using them individually. The vehicle-controlled BRIO-II study found that Yuvezzi led to significant gains in binocular uncorrected near visual acuity over 8 hours \u2014 three lines or greater \u2014 without decreasing binocular uncorrected distance visual acuity by one or more lines.<\/p>\n
\u201cYuvezzi provides a reliable once-daily eye drop that allows patients to manage the challenges of near-vision tasks without giving up distance visual acuity,\u201d Mile Brujic, OD, FAAO,<\/b> of Premier Vision Group in Ohio, told Healio.<\/p>\n
The most common side effects are headache, impaired vision, and temporary eye pain or irritation. Rates of eye redness in both trials were low. No treatment-related serious adverse events were observed across more than 72,000 treatment days in BRIO-II, according to the release.<\/p>\n
\u201cPhase 3 pivotal trials for Yuvezzi included the largest and longest safety study in the world for a presbyopia eye drop,\u201d Brujic said. \u201cThey demonstrated Yuvezzi\u2019s durability, favorable tolerability profile, low hyperemia rates and ability to improve reading performance. The product attributes and study performance give me confidence that Yuvezzi will be very well received by our presbyopic patients.\u201d<\/p>\n
For more information:<\/h2>\n Mile Brujic, OD, FAAO,<\/b> can be reached at mile.brujic75@gmail.com. John A. Hovanesian, MD, FACS,<\/b> can be reached at jhovanesian@harvardeye.com. <\/p>\n\n
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