Brolucizumab Demonstrates Positive Results in Treatment of Diabetic Macular Edema at Dosing Intervals of 16 Weeks
According to the investigators, both trials demonstrated an overall well-tolerated safety profile for brolucizumab.
Patients with diabetic macular edema (DME) had similar gains in visual acuity and greater reductions in central subfield thickness (CSFT) and in number of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF) on a 12- to 16-week dosing schedule of brolucizumab (Beovu, Novartis) compared to aflibercept on a 4-week dosing schedule, according to the results of 2 phase 3 trials comparing the drugs. According to the investigators, both trials demonstrated an overall well-tolerated safety profile for brolucizumab.
“Patients with DME often struggle to adhere to burdensome treatment schedules as they manage various comorbidities related to diabetes,” said Dr. med. Justus Garweg, clinic director, Berne Eye Clinic at Lindenhof Hospital, Switzerland, in a press release. “The extended dosing and fluid resolution observed in the KITE clinical trial suggest Beovu has the potential to manage the disease in appropriate patients with a relaxed loading phase every 6 weeks, and dosing intervals as infrequent as every 12 or 16 weeks.”
The phase 3 KITE and KINGFISHER trials are global, randomized, double-masked, 2-year studies comparing the safety and efficacy of brolucizumab and aflibercept in the treatment of DME. Both trials met their primary endpoint of non-inferiority to aflibercept in best-corrected visual acuity (BCVA) from baseline. Further, brolucizumab demonstrated superiority versus aflibercept in key fluid-related secondary endpoints in both trials, including reductions in CSFT and in number of eyes with IRF/SRF, according to the investigators.
“The year two KITE results reaffirm that Beovu may meet an important need to extend dosing intervals for patients with diabetic macular edema, who are often overburdened with medical appointments,” said Jill Hopkins, MD, global development unit head of Ophthalmology at Novartis Pharmaceuticals, in the release. “Along with the top-line results from KINGFISHER, the KITE findings add to the growing body of data supporting our understanding of where Beovu may potentially fit into the DME treatment landscape. We look forward to continuing discussions with global health authorities about the findings from the KESTREL and KITE clinical trials, and we will continue to assess the clinical relevance of the positive KINGFISHER findings.”
DME is a common microvascular complication in patients with diabetes that can have a debilitating impact on visual acuity and may eventually result in blindness. Consistently high blood sugar levels associated with diabetes can result in damage to small blood vessels in the eye, causing them to leak fluid. This results in an excess of vascular endothelial growth factor (VEGF), a protein that stimulates the growth of blood vessels. At elevated levels in DME, VEGF stimulates the growth of abnormal, leaky blood vessels, which results in edema in the macula that can lead to vision loss.
The most common adverse events (AEs) in the KITE trial were cataract and dry eye. Rates of intraocular inflammation (IOI) in KITE were 2.2% for brolucizumab and 1.7% for aflibercept, and no retinal vasculitis (RV) was reported in either arm. In the KINGFISHER trial, the most common (≥5%) AEs were COVID-19 and hypertension. Rates of IOI were 4.0% for brolucizumab (including 0.9% RV) and 2.9% for aflibercept (including 0.6% RV).
Novartis announces positive results from Phase III trials of Beovu® in diabetic macular edema, including dosing intervals up to 16 weeks [news release]. Novartis; August 17, 2021. Accessed August 17, 2021. https://www.novartis.com/news/media-releases/novartis-announces-positive-results-from-phase-iii-trials-beovu-diabetic-macular-edema-including-dosing-intervals-16-weeks