Three studies affirm efficacy, safety of brolucizumab in DME
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WAIKOLOA, Hawaii — Brolucizumab 6 mg demonstrates a favorable benefit-risk profile in the treatment of patients with diabetic macular edema, according to a presentation at Retina 2022.
“To conclude on the summary of all three of these clinical trials, brolucizumab 6 mg was noninferior to aflibercept in respect to visual acuity at week 52 with fewer injections in the KESTREL and KITE study,” Michael S. Ip, MD, said during a presentation offering topline summarization of the KESTREL, KITE and KINGFISHER trials investigating the safety and efficacy of brolucizumab (Novartis). “With respect to central subfield thickness, the 6 mg brolucizumab arm in KITE had a superior result.”
KESTREL and KITE are 2-year, ongoing, double-masked, multicenter phase 3 trials. Patients in KESTREL were randomly assigned to receive brolucizumab 3 mg, brolucizumab 6 mg or aflibercept 2 mg. Patients in KITE were randomly assigned to receive brolucizumab 6 mg or aflibercept 2 mg.
In KINGFISHER, 495 patients were randomly assigned 2:1 to receive monthly injections of either brolucizumab 6 mg or aflibercept 2 mg.
“Pooled KESTREL and KITE analysis demonstrated noninferiority on two-step or greater improvement from baseline at week 52 between brolucizumab 6 mg and aflibercept (P < .001),” Ip wrote in the presentation.
Safety data from all three trials show “no evidence that underlying diabetes has a negative impact on the related incidence of intraocular inflammation.”
In KESTREL, 70% of patients who completed the 12-week dosing interval during the first year remained on the same schedule through year 2. Additionally, more patients who received brolucizumab experienced either intraretinal or subretinal fluid resolution, Ip said.
In the KINGFISHER trial, brolucizumab met the primary endpoint of noninferiority to aflibercept in change in best corrected visual acuity from baseline through week 52 when dosed every 4 weeks. Brolucizumab showed superiority in reduction of central subfield thickness and the number of eyes with intraretinal fluid or subretinal fluid, Ip said.
“The KINGFISHER results reaffirmed the findings we saw in KESTREL and KITE with a monthly regimen out through 1 year,” he said.
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Ip MS. Brolucizumab for the treatment of diabetic macular edema: Update from the KESTREL, KITE & KINGFISHER studies. Presented at: Retina 2022; Jan. 15-21, 2022; Waikoloa, Hawaii.
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