While there have been several significant steps forward when it comes to treating diabetes complication diabetic macular edema (DME) this year, current therapies are still not effective enough, according to GlobalData. The leading data and analytics company notes that not only is there still a surplus of unmet needs, but current therapies still have quite a heavy treatment burden. Further, several key opinion leaders (KOLs) interviewed by GlobalData spoke out to say that a significant number of DME patients do not respond well to current standard-of-care therapies.

According to GlobalData’s latest report, ‘Diabetic Macular Edema Drugs in Development by Stages’, two DME drugs have been approved in 2022 so far: Roche’s Vabysmo in January and Novartis’s Bevou in March. This has heightened competition within the international DME market.

Sara Reci, Pharmaceutical Analyst at GlobalData, comments: “The recent approvals of novel DME therapies are of great significance, as these therapies help tackle patient compliance—a long-standing issue among DME patients. However, despite this progress, treatment burden is still high and patients are left with a lot of unmet needs.”

For example, in March, the EC decided to approve Novartis’s Beovu as it demonstrated superior improvement among DME patients in comparison to Regeneron Pharmaceuticals’s Eylea, which is generally accepted as the standard-of-care. However, its safety profile remains a concern.

Sara Reci, Pharmaceutical Analyst at GlobalData, comments: “KOLs interviewed by GlobalData expressed their concerns towards administering Beovu to patients, emphasizing brolucizumab’s safety warning—including its potential to cause serious inflammation, which has deterred many clinicians from prescribing the therapy. Clinicians will most likely only prescribe Beovu as a last resort, if other pharmacotherapy options fail.”

The treatment burden associated with the current standard-of-care therapies is an area that newer therapies are keen to address. For instance, Roche’s Vabysmo is expected to compete directly against Eylea due to its more flexible dosage and treatment intervals. Vabysmo and Eylea, both VEGF inhibitor treatments, are administered via 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.

Reci adds: “The lack of therapies available on the market that can effectively treat DME emphasizes the surplus of unmet needs that are yet to be addressed, and the increasing opportunities for new innovative entrants in the DME space that will make a difference to patients. However, the compelling evidence for Roche’s Vabysmo bring us one step forward towards improving the experience of DME patients through alleviating patient burden.”