Ophthalmology

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.

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.

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

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.

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).

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.

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.

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).

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.

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.

Data suggest that intravitreal bevacizumab increases the risk of thromboembolism, and some studies have raised the possibility of a link between bevacizumab and myocardial infarction (MI), while other studies did not find such a relationship.

Last week, an overview of systematic reviews and meta-analyses investigating systemic adverse events associated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatments was published in JAMA Ophthalmology.

One week after intravitreal bevacizumab injection, corneal endothelial cells showed no sign of inflammation or any other complications, according to a study published in BMC Ophthalmology.

While corticosteroids are a common treatment for uveitis, effective corticosteroid-sparing therapies are necessary to maintain disease control without risking corticosteroid-related adverse events.

Intravitreal injection of bevacizumab (Avastin) has revolutionized the treatment of diabetic eye disease, and has emerged as an important treatment modality, either as primary or adjuvant therapy for diabetic macular edema and proliferative diabetic retinopathy.

Momenta Pharmaceuticals and Mylan have announced that they will begin a pivotal clinical trial of their jointly developed M710, a proposed biosimilar of the anti–vascular endothelial growth factor (anti-VEGF) therapy aflibercept, referenced on Eylea.

A recent study examined whether the use of the anti–tumor necrosis factor agent infliximab could reduce the death of photoreceptors after retinal detachment in an experimental mouse model.

Lucentis (ranibizumab) faces oncoming competition from 4 companies that are developing proposed biosimilars.

German drug maker Formycon released its third quarter financial results on Monday, and reported that it plans to launch its biosimilar ranibizumab candidate, FYB201, in the United States in 2020.

Current regulations discourage the use of the more cost-effective bevacizumab and lead to unequal patient access to higher-cost ranibizumab and aflibercept.

Roche’s sales of ranibizumab (Lucentis), already depleted by competition from such products as afilbercept (Eylea), face upcoming erosion from biosimilar competition.