First Biosimilar Approved for Macular Degeneration, Other Eye Conditions – Consumer Health News

THURSDAY, Sept. 23, 2021 (HealthDay News) — The first biosimilar to Lucentis (ranibizumab injection) has been accredited for the remedy of neovascular (moist) age-associated macular degeneration and different eye ailments and situations, the U.S. Food and Drug Administration introduced Friday.The approval of the biosimilar, Byooviz (ranibizumab-nuna), can be indicated to deal with macular edema after retinal vein occlusion and myopic choroidal neovascularization. Byooviz is run month-to-month by way of intravitreal injection.Approval was based mostly on an information evaluation that included “intensive structural and practical characterization, comparative medical efficacy and security evaluations, together with potential immunogenicity that demonstrated Byooviz is biosimilar to Lucentis,” the FDA wrote in a press launch. Potential severe uncomfortable side effects attributable to Byooviz administration embrace endophthalmitis and retinal detachments, elevated intraocular strain, and thromboembolic occasions. The mostly reported uncomfortable side effects included conjunctival hemorrhage, eye ache, vitreous floaters, and elevated intraocular fluid strain.The FDA has up to now accredited 31 biosimilars for the remedy of varied well being situations. “Continuing to develop the variety of biosimilar approvals is a key a part of our efforts to offer larger entry to remedy choices for sufferers, enhance competitors and doubtlessly decrease prices,” Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars within the FDA Center for Drug Evaluation and Research, stated within the press launch.More Information

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