Novartis announced in October that the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted applications for a range of approvals for brolucizumab (Beovu) in the treatment of DME. The drug, a humanized single-chain antibody fragment that binds to VEGF-A, was approved by the FDA to treat wet AMD in 2019.

These acceptances are based on Novartis’s KESTREL and KITE head-to-head studies of brolucizumab in comparison with aflibercept (Eylea; Regeneron) in DME. These trials demonstrated not only noninferiority of brolucizumab but also that, following loading doses at 6-week intervals, more than half of patients receiving brolucizumab could be extended out to 12-week dosing intervals through the first year of treatment. Brolucizumab also proved more effective than aflibercept in eliminating subretinal fluid, and most side effects were mild and manageable.

This announcement comes on the heels of the previous month’s announcement that Novartis had acquired Arctos Medical, a Switzerland-based company conducting preclinical research on using AAV technology to deliver a light-sensitive optogene therapy to target destroyed photoreceptors in patients with inherited retinal dystrophies and advanced dry AMD.

“We’ve watched this technology develop and mature into a therapeutic program that complements our existing portfolio and gives us new optogenetics technology to wield in our efforts to bring desperately needed therapeutic options to patients for these blinding diseases,” said Cynthia Grosskreutz, global head of ophthalmology at the Novartis Institutes for BioMedical Research, in a news release.