Novartis’ Diabetic Macular Edema Drug Successful in 2 Trials

Novartis recently announced that two Phase 2 clinical trials assessing its diabetic macular edema drug, Beovu, demonstrated overall well-tolerated safety profiles.

The global, randomized Kite and Kingfisher trials compared the safety and efficacy of Beovu six milligrams and aflibercept two milligrams to treat diabetic macular edema. Both trials enrolled 926 patients in 36 countries, respectively. 

In the Kite trial, researchers maintained patients on a 12-or 16-week dosing interval through the end of the study. A majority of these patients successfully completed an initial 12-week cycle following the loading phase. 

Kite met its primary endpoint of non-inferiority to aflibercept in best-corrected visual activity (BCVA) from baseline at one year. 

Overall, Beovu elicited more significant reductions than aflibercept in central subfield thickness (CSFT) and in the number of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF), researchers explained. 

Year two results were consistent with those seen at year one. 

The most common adverse events in the trial were cataracts and dry eyes. And the majority of intraocular inflammation events were manageable and resolved without any clinical complications. 

“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,” Justus Garweg, MD, professor and clinic director at Berne Eye Clinic at Lindenhof Hospital, Switzerland, said in the announcement.

The second Phase 2 trial, Kingfisher, also met its primary endpoint of non-inferiority to aflibercept in the change of BCVA from baseline at year one when dosed every four weeks.

Beovu demonstrated superiority versus aflibercept in key fluid-related secondary endpoints at one year, including reductions in CSFT and in the number of eyes with IRF/SRF.

The most common adverse events in the trial were COVID-19 and hypertension. Like Kite, most intraocular inflammation events in the Kingfisher trial were manageable and resolved with no clinical complications.

“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,” said Jill Hopkins, global development unit head of ophthalmology at Novartis. 

“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,” Hopkins continued. 

Year two findings from Kestrel, a third pivotal Phase 3 trial of Beovu in diabetic macular edema, are expected in Q4 of this year.