Ophthalmology

Xbrane Biopharma to Begin Phase 3 Trial of Ranibizumab Biosimilar

January 10th 2019

By Samantha DiGrande

Article

Swedish biotechnology company Xbrane Biopharma recently announced that it has submitted its first national Clinical Trial Application to the FDA seeking permission to begin the Xplore trial.

European Court Rules in Favor of Allowing Off-label Bevacizumab Use

November 28th 2018

By Kelly Davio

Article

This month, the Court of Justice of the European Union ruled that Italy’s national health system can reimburse for the use of bevacizumab in the treatment of eye diseases, such as age-related macular degeneration, despite the fact that bevacizumab does not have a marketing authorization for this indication.

Aflibercept Reaches Blockbuster Status as Biosimilars Advance

November 7th 2018

By Samantha DiGrande

Article

According to the earnings report, aflibercept sales in the United States increased 7% to $1.02 billion versus third quarter 2017 results.

Xbrane's Ranibizumab Biosimilar Shows Equivalent PK and Tolerability to Lucentis

October 4th 2018

By The Center for Biosimilars Staff

Article

Swedish biotechnology company Xbrane Biopharma today announced that its ranibizumab biosimilar, referencing Lucentis, demonstrated an equivalent pharmacokinetic (PK) profile and equivalent tolerability to its reference in an in vivo study.

UK Health System Wins the Right to Treat AMD With Bevacizumab

September 24th 2018

By Kelly Davio

Article

A United Kingdom court has ruled in favor of the National Health Service, allowing the health system to provide intravitreal injections of the anti–vascular endothelial growth factor agent bevacizumab to patients with age-related macular degeneration (AMD).

New Treatment Approach for Aflibercept Approved in Europe

August 5th 2018

By The Center for Biosimilars Staff

Article

The updated treatment approach will allow clinicians, based on individual patients’ outcomes, to lengthen the intervals between injections for patients with neovascular age-related macular degeneration (AMD) who are already in the first year of treatment. That could mean fewer injections and fewer trips to the clinic for patients with AMD.

Study: Etanercept Reduces Retinal Damage, Improves Visual Function After Trauma

July 25th 2018

By Kelly Davio

Article

Because tumor necrosis factor plays a role in most neurodegenerative diseases of the eye, and because etanercept has shown promise in improving recovery of injured facial nerves, authors of a recent study sought to determine whether etanercept can be used to protect retinal ganglion cells and improve visual outcomes after injury.

Biosimilar Ranibizumab Effective in Treating RVO in a Real-World Setting

July 16th 2018

By Kelly Davio

Article

In India, Razumab, manufactured by Intas Pharmaceuticals, was approved as a similar biologic to ranibizumab in 2015; the retrospective study RE-ENACT collected data and analyzed the effectiveness of this biosimilar product in the real-world setting in patients with age-related macular degeneration, diabetic macular edema, and retinal vein occlusion (RVO).

Bevacizumab May Have a Role in Treating Eales Disease

July 1st 2018

By The Center for Biosimilars Staff

Article

Eales disease (ED) is a common, idiopathic, inflammatory retinal vasculitis that particularly affects young adults. Current treatments available for ED include corticosteroids, laser photocoagulation, retinal cryotherapy, and surgery, but a recent study found that using intravitreal bevacizumab injections may produce better outcomes and reduce the need for surgery.

Study: Europe Is Overspending on AMD Treatment by Not Using Bevacizumab

May 29th 2018

By Kelly Davio

Article

In a new paper, researchers sought to describe how much the European Union is overspending on neovascular age-related macular degeneration treatment by relying on ranibizumab and aflibercept rather than bevacizumab in ophthalmology.