First Biosimilar Approved for Macular Degeneration, Other Eye Conditions
THURSDAY, Sept. 23, 2021 (HealthDay News) -- The first biosimilar to Lucentis (ranibizumab injection) has been approved for the treatment of neovascular (wet) age-related macular degeneration and other eye diseases and conditions, the U.S. Food and Drug Administration announced Friday.
The approval of the biosimilar, Byooviz (ranibizumab-nuna), is also indicated to treat macular edema after retinal vein occlusion and myopic choroidal neovascularization. Byooviz is administered monthly through intravitreal injection.
Approval was based on a data review that included "extensive structural and functional characterization, comparative clinical efficacy and safety evaluations, including potential immunogenicity that demonstrated Byooviz is biosimilar to Lucentis," the FDA wrote in a press release.
Potential serious side effects caused by Byooviz administration include endophthalmitis and retinal detachments, increased intraocular pressure, and thromboembolic events. The most commonly reported side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular fluid pressure.
The FDA has so far approved 31 biosimilars for the treatment of various health conditions. "Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs," Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA Center for Drug Evaluation and Research, said in the press release.
Related Posts
‘Motivational’ Talks Won’t Help Dieters Lose Weight: Study
TUESDAY, March 29, 2022 (HealthDay News) -- It takes a lot of will to...
Olympian Mary Lou Retton Suffers Setback in Battle With Rare Form of Pneumonia
THURSDAY, Oct. 19, 2023 (HealthDay News) -- Former Olympic gymnast Mary Lou...
Biden Plan Will Tackle Mental Health Crisis in America
FRIDAY, March 4, 2022 (HealthDay News) -- President Joe Biden has announced a...
Mild Eczema in First Grade Likely to Resolve by Sixth Grade
MONDAY, Oct. 24, 2022 (HealthDay News) -- The severity of children’s atopic...