Ophthalmology

Vial Sharing for Bevacizumab in Treating Eye Disorders Reduces Costs, Increases Access

September 18th 2019

By Kelly Davio

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.

Study Finds Aflibercept Noninferior to Ranibizumab in Macular Edema, Results With Bevacizumab Inconclusive

August 29th 2019

By Allison Inserro

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.

Eye on Pharma: FDA Gives Green Light to Aflibercept in Prefilled Syringe

August 14th 2019

By The Center for Biosimilars Staff

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.

Ahead of Biosimilar Competition, Ranibizumab Gets a Positive CHMP Opinion for New Indication

July 28th 2019

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.

Study Finds Characteristics Likely to Predict Conversion to AMD in Second Eye in Patients Treated With Anti-VEGFs

July 11th 2019

By Allison Inserro

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.

Treatment With Bevacizumab Is Noninferior to Aflibercept in Terms of Visual Acuity, Researchers Say

July 5th 2019

By Kelly Davio

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.

FDA Approves New Aflibercept Indication Ahead of Competition

May 17th 2019

By Kelly Davio

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.

Researchers Report on Advances With Bevacizumab in Treating Eye Disorders

May 5th 2019

By Kelly Davio

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.

Phase 3 Trial Begins of Xbrane Biopharma's Ranibizumab Biosimilar

April 23rd 2019

By Allison Inserro

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.

Alteogen Secures Process Patent for Its Aflibercept Biosimilar

January 13th 2019

By The Center for Biosimilars Staff

Republic of Korea-based biosimilar developer Alteogen has reported that it has been granted a process patent for its method of producing an aflibercept biosimilar, ALT-L9, referencing Regeneron’s innovator drug Eylea.