Novartis Announces Positive Topline Results from First Phase III KITE Trial of Beovu® vs. Aflibercept in Diabetic Macular Edema

September 15, 2020 /BioValleyBIOON/ --Novartis(Novartis) recently announced the treatment of new-generation ophthalmic drug Beovu (brolucizumab)DiabetesPositive Topline Results from the Pivotal Phase III KITE Study in Diabetic Macular Edema (DME). This is the first Phase III study comparing Beovu with Eylea (aflibercept) for the treatment of DME, demonstrating that the study met its primary and key secondary endpoints: at one year (52 weeks) of treatment,Beovu 6 mg was non-inferior to aflibercept 2 mg in terms of mean change in best-corrected visual acuity (BCVA).

In a key secondary endpoint, during the first year of treatment,More than half of the patients in the Beovu group maintained a 3-month dosing interval after the loading phase., in the aflibercept group, all patients maintained a 2-month dosing interval after the loading phase. Regarding another secondary endpoint, during weeks 40–52,Beovu demonstrated superior improvement compared to aflibercept in changes in central subfield thickness (CST), a key indicator of retinal fluid.In this study, Beovu demonstrated a generally well-tolerated safety profile, comparable to that of aflibercept. Additionally, Beovu and aflibercept’sThe incidence of intraocular inflammation was comparable.

NovartisDirk Sauer, Global Head of Ophthalmology at Novartis, stated: “Diabetic macular edema (DME) has a significant impact on patients’ lives and requires frequent intravitreal injections to control the accumulation of intraocular fluid. These data reinforce our strong conviction in Beovu as a potential therapy for patients with DME. If approved, Beovu will provide patients with a new treatment option to manage their disease by more effectively resolving retinal fluid and reducing central subfield thickness (CST).”

The KITE study is an ongoing 2-year study conducted at 80 sites across 23 countries worldwide.Clinical TrialThe center enrolled 360 patients with diabetic macular edema (DME). Data from the KITE study will be submitted to medical conferences and peer-reviewed publications. Regarding DME, Novartis is currently conducting a second study, KESTREL, with results expected later this year, at which timeNovartisNext steps will be evaluated with the regulatory authorities.

NovartisActively advancing the comprehensive clinical development program for Beovu, including wet age-related macular degeneration (wet-AMD), diabetic macular edema (DME), retinal vein occlusion, and proliferativeDiabetesResearch on Retinopathy. The favorable benefit-risk profile of the Beovu development project was approved by the U.S.FDASupport for reviews of ongoing studies.

Diabetic Macular Edema - DME (Image source: bceye.com)

DME isDiabetesThe leading cause of blindness in patients, affecting 21 million people worldwide, with type 1DiabetesPatients accounted for 12%, and patients with type 2 diabetes accounted for 28%.

Sustained high blood glucose levels associated with diabetes can damage the small blood vessels in the eyes, causing them to leak fluid. Fluid accumulation in the macula (known as edema) can lead to vision loss. The macula is the area of the retina responsible for clear central vision.

DMEEarly symptoms include blurred or wavy central vision and distorted color perception, but the disease may also progress asymptomatically in its early stages.

Beovu is a next-generation anti-vascular endothelial growth factor (VEGF) drug, approved in the United States in October 2019 and in the European Union in February 2020 for the treatment of wet age-related macular degeneration (wet-AMD). To date, Beovu has been approved for marketing in more than 40 countries worldwide. In June this year, the U.S. labeling for Beovu was updated to include additional safety information regarding retinal vasculitis and retinal vascular occlusion.

Wet AMD is a leading cause of blindness, affecting over 20 million people worldwide, and frequent intravitreal injections are a common reason for wet AMD patients to discontinue treatment.

Notably, Beovu is the first anti-VEGF agent with efficacy comparable to Eylea (aflibercept) that allows for a 3-month maintenance dosing interval following a 3-month loading phase in eligible patients with wet AMD, without compromising efficacy. By reducing the frequency of injections, it improves patient adherence to treatment, thereby effectively maintaining visual acuity.

The active pharmaceutical ingredient of Beovu is brolucizumab (RTH258), a humanized single-chain antibody fragment (scFv) that targets all isoforms of vascular endothelial growth factor-A (VEGF-A). Single-chain antibody fragments have garnered significant attention in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation, and favorable drug delivery properties.

Brolucizumab’s innovative structure results in a small molecular weight of only 26 kDa, enabling potent inhibition of all VEGF-A isoforms with high affinity. In preclinical studies, brolucizumab inhibited the activation of VEGF receptors by blocking ligand-receptor interactions. Increased signaling through the VEGF pathway is associated with pathological ocular angiogenesis and retinal edema. In patients with chorioretinal vascular diseases, inhibition of the VEGF pathway suppresses the growth of neovascular lesions, alleviates retinal edema, and improves visual acuity. (Bioon.com)

Original Source: Novartis reports positive topline results from the first Phase III trial of Beovu® versus aflibercept in patients with diabetic macular edema (DME)