Ophthalmology

Even as biosimilars of anti–vascular endothelial growth factor (anti-VEGF) agents are coming to market and advancing through the pipeline, a new agent that may have substantial benefits for patients with wet age-related macular degeneration (AMD) has been approved by the FDA: brolucizumab, which sponsor Novartis will sell as Beovu.
Vial sharing for bevacizumab that would otherwise have been discarded yielded a 97.88% reduction in the total cost of a single year of intravitreal injections, as well as a 96.54% increase in the number of injections performed.
Treating macular edema associated with central retinal vein occlusion (CRVO) with aflibercept was noninferior to ranibizumab treatment at 100 weeks, while the results for bevacizumab versus ranibizumab were inconclusive.
Regeneron’s aflibercept (Eylea) has been approved by the FDA for a prefilled syringe (PFS) presentation. The 2-mg, single-dose, PFS will offer the greater ease of use less preparation than the vial presentation of the drug used to treat a range of eye disorders.
Novartis, developer of the brand-name Lucentis, announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted the drug a positive opinion for the treatment of retinopathy of prematurity in infants.
A secondary post hoc analysis of patients who had neovascular age-related macular degeneration (AMD) and were treated with intravitreal aflibercept or ranibizumab—2 widely used anti-vascular endothelial growth factor (anti-VEGF) therapies—found that those with certain characteristics had a substantial risk of conversion to AMD in the untreated eye.
Anti–vascular endothelial growth factor therapy is the standard of care for the first-line treatment of macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, and a number of therapeutic options are available, including aflibercept, ranibizumab, and off-label bevacizumab.
The FDA this week approved Regeneron’s aflibercept (Eylea) to treat all stages of diabetic retinopathy. The regulatory decision makes aflibercept the only anti–vascular endothelial growth factor therapy approved for 2 dosing regimens in this indication: every 8 weeks or every 4 weeks.
During this week’s Association for Research in Vision and Ophthalmology 2019 Annual Meeting, researchers presented new findings on the utility—and the delivery—of bevacizumab in eye disorders.
Xbrane Biopharma, a Swedish biotechnology company, says it is starting its phase 3 trial of its ranibizumab biosimilar, referencing Lucentis, and also set sales targets for the treatment for patients with wet age-related macular degeneration.
 

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