Indication of Norvatis Beovu's DME was expanded

Novartis Korea announced on the 17th that Beovu, an Age-related macular degeneration treatment, has added diabetic macular edema (DME).

 

Beovu is a treatment that inhibits neonatal vascular expression and retinal effusion leakage in combination with VEGF-A.

 

The Beovu dose for DME treatment is administered once every 6 weeks, 6 mg (0.05 mL) for the first 5 times, and once every 12 weeks thereafter.

 

Patients with disease activity can be administered once every eight weeks.

 

The administration interval is determined based on disease activity evaluated on vision and/or anatomical criteria.

 

This permission was based on the results of 2 phase 3 clinical trials, KESTREL and KITE, which directly compared the efficacy and safety of the existing treatment, Aflibercept.

 

The clinical trial was conducted on 926 patients with type 1 or type 2 diabetes (566 KESTREL and 360 KITE) aged 18 or older with impaired vision due to diabetic macular edema.

 

In the Beovu medication group, loading dose was administered 5 times every 6 weeks, then administered every 12 weeks, and patients with confirmed disease activity were administered every 8 weeks.

 

The control group was administered 5 times every 4 weeks with loading dos according to the drug's permission and then administered every 8 weeks.

 

At the first year (52 weeks), the median was administered 7 times in the Beovu medication group and 9 times in the control group.

 

The researchers said that existing anti-VEGF treatments that treat DME were usually administered monthly when administering loading dose, making it difficult to improve the patient's treatment burden and resulting symptoms, and based on the results of this study, Blucizumab-dbll will be a new treatment option to reduce the treatment burden for diabetic macular edema.

 

DME is a disease that causes swelling in the macula by increasing vascular endothelial growth factors and proliferating new blood vessels as exudates flow from damaged microvascular vessels due to the inability to control high blood sugar.

 

According to a paper published in 2011, DME is a major disease that causes blindness in adults in developed countries, with 12% of type 1 diabetes patients and 28% of type 2 diabetes patients being affected.

 

Cho Yeon-jin, executive director of Novartis Korea's ophthalmology division, said, "We are pleased to expand treatment options to patients suffering from vision damage following Lucentis with the expansion of indications for the treatment of diabetic macular edema." Executive Director Cho Yeon-jin explained, "Novatis will continue to have leadership in the field of eye disease treatments and make efforts to introduce treatments with efficacy and safety to clinical sites."