The FDA has approved YUVEZZI, the first dual-agent eye drop, to treat presbyopia, a leading cause of vision loss in adults.
The medication uses a fixed-dose combination of carbachol (2.75%) and brimonidine (0.1%) to create a “pinhole effect” that sharpens vision at close range, according to Tenpoint Therapeutics that makes the product.
Carbachol constricts the iris sphincter and ciliary body, while brimonidine tartrate prevents contraction of the iris dilator muscle, allowing for the absorption of carbachol in the aqueous humor.
The approval comes following the results from two phase 3 trials. In the first trial, BRIO I, the combination treatment was more effective than each of its individual components alone.
In the second trial, BRIO II, YUVEZZI was compared with an inactive control. Patients who received the combination drops reported a significant improvement in reading three or more lines on a near vision eye chart for over 8 hours, without losing distance vision.
In both the trials, the rate of ocular hyperemia was low, according to the company. In BRIO II, the incidence of ocular hyperemia was lower in patients who received the product (2.8%) than in those treated with carbachol alone (10.7%).
The most common side effects of YUVEZZI were headaches, blurred vision, and temporary pain or irritation of the eyes.
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