The FDA has granted a priority review designation for RTH258 (Brolucizumab, Novartis) for the treatment of wet age-related macular degeneration (AMD). RTH258 is a humanized single-chain antibody fragment (scFv) and the most clinically advanced scFv to reach this stage of development.

By 2020, more than 1.5 million people in the U.S. are expected to have wet AMD, a leading cause of blindness worldwide and a major public health concern. As wet AMD progresses, patients may have loss of central vision, preventing their ability to complete daily tasks. Lack of treatment can eventually lead to blindness.

The priority review is based on data from the phase 3 prospective, randomized, double-masked, multicenter HAWK and HARRIER trials. The studies were designed to compare the efficacy and safety of intravitreal injections of RTH258 versus aflibercept in patients with wet AMD.

The trials are the first and only global head-to-head studies in more than 1,800 patients with wet AMD to demonstrate efficacy at week 48 beginning with a 12-week dosing regimen. Also, significantly fewer RTH258 patients showed central subfield retinal thickness, disease activity, and retinal fluid, key markers that physicians use to help guide disease management.

The most frequent adverse events were conjunctival hemorrhage; reduced visual acuity; vitreous floaters; eye pain; retinal hemorrhage; cataract; vitreous detachment; and dry eye.

If approved by the FDA, RTH258 could be launched as early as the end of 2019.

Source: Novartis AG, April 15, 2019



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