Novartis reported the first interpretable results of the Phase III KITE study, assessing the efficacy and safety of Beovu® (brolucizumab) 6 mg in diabetic macular edema (DME). The trial met its primary and key secondary endpoints, demonstrating non-inferiority for Beovu versus aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52).
In a secondary endpoint, Beovu demonstrated superior improvement versus aflibercept in change of central subfield thickness (CST, a key indicator of fluid in the retina) over the period of week 40 through week 52. More than half of patients in the Beovu arm were maintained on a three-month dosing interval through year one, following the loading phase. All aflibercept patients were on a two-month dosing interval after the loading phase. In KITE, Beovu demonstrated an overall well-tolerated safety profile comparable to aflibercept. In addition, the rate of intraocular inflammation was equivalent between Beovu and aflibercept.
“Living with DME has significant impact on patients’ lives and frequent treatment injections are needed to control the increased fluid in the eye,” said Dirk Sauer, Global Head Development, Novartis Pharma Ophthalmology. “This data confirms our strong belief in Beovu as a potential therapy for DME patients, and if approved, will provide patients with a new treatment option to control their disease through better resolution of retinal fluid and CST reductions.”
The KITE pivotal trial is an ongoing two-year study that enrolled 360 patients with DME across 80 centers in 23 countries. The data from KITE will be submitted for presentation at medical congresses and for peer-review publication. Novartis is currently conducting a second study in DME, KESTREL, and anticipates results later in the year, when Novartis will assess next steps with health authorities.
DME is the leading cause of blindness in people with diabetes and affects 21 million people across the world, including 12% of people with type 1 diabetes and 28% of those with type 2 diabetes.
Consistently high blood sugar levels associated with diabetes can damage small blood vessels in the eye, causing them to leak fluid. The resulting accumulation of fluid (known as edema) in the macula can lead to vision loss6. The macula is the area of the retina responsible for sharp, central vision.
Early symptoms of DME include blurry or wavy central vision and distorted color perception, although the disease can also progress without symptoms at early stages.
The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms. Beovu is engineered to deliver the highest concentration of drug, providing more active binding agents. In preclinical studies, Beovu inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions and suppress endothelial cell proliferation and vascular permeability.
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