Novartis has announced that the US Food and Drug Administration (FDA) has approved BEOVU® (brolucizumab-dbll) 6 mg for the treatment of diabetic macular edema (DME). Today’s approval represents the second FDA-approved indication for BEOVU, which was first approved for the treatment of wet age-related macular degeneration in 2019.
The FDA approval was based on year one data from the Phase III, randomized, double-masked KESTREL and KITE* studies, which met their primary endpoint of non-inferiority in change in best-corrected visual acuity (BCVA) from baseline versus aflibercept at year one. In aggregate, a numerically lower proportion of patient eyes treated with BEOVU had intraretinal fluid, subretinal fluid or both at week 52 versus eyes treated with aflibercept.
Through year one, half of BEOVU patients remained on a 12-week dosing interval following the loading phase. During this time (by week 52), patients received a median of seven BEOVU injections. Patients treated with BEOVU demonstrated a significant reduction from baseline in central subfield thickness (CST) starting at week four and continuing up to week 52.
Per the approved BEOVU prescribing information, following the loading phase of five doses injected six weeks apart, patients should be treated once every eight to 12 weeks. Throughout the KESTREL and KITE trials, aflibercept patients were dosed every eight weeks, as recommended in its FDA-approved label.
“The FDA approval of BEOVU in DME marks a significant milestone for US DME patients, many of whom are of working age and struggle with treatment adherence while juggling multiple doctor’s visits every month,” said Jill Hopkins, SVP and Global Development Unit Head, Ophthalmology, Novartis. “KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting BEOVU may offer fewer injections from the start of treatment through year one. We look forward to offering a new treatment option to help address the unmet needs of patients with DME. This FDA approval follows the recent European Commission approval and allows more patients around the world to potentially benefit from this important medicine.”
The most common adverse event (≥5%) reported in patients who received BEOVU in the DME clinical trials was conjunctival hemorrhage. Intraocular inflammation (IOI) rates in KESTREL were 4.7% for brolucizumab 3 mg, 3.7% for BEOVU 6 mg, and 0.5% for aflibercept 2 mg.
Novartis remains committed to bringing BEOVU to appropriate patients who may benefit from this important medicine. As of June 2022, BEOVU is available as a pre-filled syringe in the US. This will provide eye care professionals an option that offers fewer steps than the vial.
Read the full press release from Novartis.