Brolucizumab effective treatment for DME visual impairment
The 52-week results from 2 phase 3 studies show that brolucizumab (Beovu; Novartis) provides robust vision improvements and superior anatomical outcomes with dosing every 12-week (q12w) intervals in more than 50% of patients with diabetic macular edema (DME), according to a presentation at ARVO 2021 Virtual.
KITE and KESTREL are 2-year, ongoing multicenter studies evaluating the efficacy and safety of brolucizumab versus aflibercept (Eylea, Regeneron) for the treatment of patients with visual impairment due to DME. The studies included adults with type 1 or type 2 diabetes mellitus and visual impairment due to DME with a best corrected visual acuity (BCVA) score between 78 to 23 ETDRS letters and DME involving the center of the macula with a central subfield thickness (CST) ≥320 µm on SD-OCT in the study eye at screening.
In KITE, patients were randomized to brolucizumab 6 mg or aflibercept 2mg. In KESTREL, patients were randomized 1:1:1 to brolucizumab 3mg, brolucizumab 6 mg and aflibercept 2 mg. Patients in the brolucizumab groups received 5 loading doses every 6 weeks (q6w) followed by q12w dosing in the first year, with an option to adjust to every 8-week dosing (q8w) at predefined disease activity assessment visits. The aflibercept group received 5 loading doses monthly followed by fixed q8w dosing. The primary endpoint was the change from baseline in BCVA at Week 52, while secondary endpoints were the proportion of brolucizumab patients maintained at q12w dosing up to Week 52 and the change from baseline in CST.
For the KITE study, the primary objective was achieved with brolucizumab 6 mg non-inferior to aflibercept 2 mg in the change from baseline in BCVA at Week 52. More than 50% of brolucizumab 6 mg patients were maintained on a q12w dosing interval through Week 52, following the loading phase. Brolucizumab 6 mg showed superior improvements versus aflibercept 2 mg in the change from baseline in CST over the period of Week 40 through Week 52. Brolucizumab 6 mg demonstrated a well-tolerated safety profile comparable to aflibercept 2 mg and the intraocular inflammation rate was equal between brolucizumab 6 mg and aflibercept 2 mg.
In KESTREL, patients receiving brolucizumab 6 mg gained a mean of 9.2 letters versus 10.5 letters for patients on aflibercept 2 mg.
“Treatment for diabetic macular edema is a high unmet medical need in the US and globally. Our goal as physicians is to work on preventing blindness for the significant proportion of diabetics affected by this condition,” said David M Brown MD FACS, Director of Clinical Research at the Retina Consultants of Texas and principal investigator of the KESTREL clinical trial in a press release. “DME patients often struggle with adherence due to the need to manage multiple comorbidities related to diabetes. The KESTREL and KITE clinical trials – the first pivotal trials to examine a longer dosing interval in the loading phase – confirm Beovu’s potential to be an important therapy for these patients.”
Brown DM, et al. Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KITE and KESTREL studies. Presented at: ARVO 2021 Virtual.