Phase III trials for Novartis’s Beovu meet primary endpoints
pharmafile | August 17, 2021 | News story | Manufacturing and Production |
Novartis has announced positive results from two Phase III clinical trials assessing Beovu in patients with diabetic macular edema.
Year two of the KITE trial evaluated Beovu on up to 16-week dosing intervals, and the one-year KINGFISHER study evaluated Beovu dosed every four weeks.
Both trials demonstrated an overall well-tolerated safety profile and met primary endpoints.
Dr Justus Garweg, Clinic Director, Berne Eye Clinic at Lindenhof Hospital, Switzerland, said: “Patients with DME often struggle to adhere to burdensome treatment schedules as they manage various comorbidities related to.
“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 six weeks, and dosing intervals as infrequent as every twelve or sixteen weeks.”
Jill Hopkins, Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals, said: “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.
“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.”
Diabetic macular edema (DME) is a common microvascular complication in patients with diabetes that may have a debilitating impact on visual acuity, eventually leading to blindness. DME is the leading cause of blindness in adults in developed countries, affecting 12% of patients with type 1 diabetes and 28% of those with type 2 diabetes.