Recently, the diabetic macular edema (DME) space witnessed new approvals; the European Commission (EC) announced the approval of Novartis’s Beovu (brolucizumab), a vascular endothelial growth factor (VEGF) inhibitor therapy, whereas Roche’s Vabysmo (faricimab-svoa), also a VEGF inhibitor therapy, was launched in both the US and Japanese markets. The approval of these therapies is of great significance due to facilitating patient compliance to therapy, an issue that has been long-standing among DME patients, many of whom are of working age. DME, a leading cause of blindness among diabetic patients, is primarily treated by VEGF inhibitor therapies, with corticosteroids being administered as second-line therapy.
Currently, the standard of care for DME is Bayer’s Eylea (aflibercept), also a VEGF inhibitor. However, on 31 March, the EC announced the approval of Beovu, which demonstrated superior improvement among DME patients in comparison to Eylea in Phase III trials KESTREL and KITE. More than 50% of subjects were maintained on three-month dosing intervals, as opposed to the standard two-month intervals for Eylea. Furthermore, Beovu demonstrated non-inferiority in mean change in best-corrected visual acuity (BCVA) and demonstrated greater reductions in central subfield thickness (CST) in comparison to Eylea. However, despite Beovu’s promising clinical trial results against Eylea, some key opinion leaders (KOLs) interviewed by GlobalData expressed concerns about administering Beovu to their patients, emphasising brolucizumab’s safety warning, including its potential to cause serious inflammation, which as a result has deterred many clinicians from prescribing the therapy to their patients.
The decision to approve Beovu comes on the heels of the US Food and Drug Administration (FDA) approval of Roche’s Vabysmo (faricimab-svoa), also a VEGF inhibitor, which recently launched in the US on 28 January and Japan on 28 March, and is currently under review by the European Medicines Agency (EMA). While Beovu has been approved in the US since late March, Vabysmo is expected to compete directly against Eylea due to its more flexible dosage and treatment intervals. Both VEGF inhibitor treatments are administered using the intravitreal route; while Eylea is administered every two months, Vabysmo can be administered every four months, significantly reducing the burden of inpatient treatment time, which will increase DME patients’ adherence to treatment regimens. Furthermore, in the YOSEMITE study, subjects treated with Vabysmo showed greater reductions in CST, as opposed to subjects treated with Eylea.
Nevertheless, current therapies on the market are still not effective enough in treating DME, and there is a growing need for subtype-specific treatments. KOLs interviewed by GlobalData have voiced their apprehension relating to such affairs, due to the significant number of DME patients not doing well with current standard-of-care therapies, emphasising the surplus of unmet needs that are yet to be addressed and the increasing opportunities for new innovative entrants in the DME space. Specifically, the lack of subtype-specific treatment options for DME signifies the plethora of opportunities available for pharmaceutical companies to make a difference to DME patients. Yet, the recent approvals of novel DME therapies are of great significance, as they tackle the long-standing issue of patient compliance among DME patients.