FDA Approves First Biosimilar Treatment for Common Eye Conditions
The US Food and Drug Administration (FDA) has approved the first biosimilar intravitreal injection, ranibizumab-nuna (byooviz) for the treatment of neovascular age-related macular degeneration (nAMD), among other eye diseases and conditions.
After an extensive review of evidence, this treatment was determined to be biosimilar to ranibizumab injection (lucentis). Macular edema following retinal vein occlusion, and myopic choroidal neovascularization are among the other eye conditions approved to be treated with ranibizumab-nuna.
This intravitreal injection is administered once a month. Common adverse effects include conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular fluid pressure. Endophthalmitis, retinal detachments, increases in intraocular pressure, and thromboembolic events may also occur.
“Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products,” said the director of the FDA’s Office of Therapeutic Biologics and Biosimilars Sarah Yim, MD. “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.”
FDA approves first biosimilar to treat macular degeneration disease and other eye conditions. News release. US Food and Drug Administration; September 17, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-macular-degeneration-disease-and-other-eye-conditions