Philippine FDA approves Novartis medicine brolucizumab for the treatment of visual impairment due to diabetic macular edema

• The Philippine Food and Drug Administration (FDA) has approved brolucizumab for the treatment of visual impairment due to diabetic macular edema (DME), a common microvascular complication in patients with diabetes that may have a debilitating impact on visual acuity, eventually leading to blindness.
• This approval marks a significant milestone for DME patients, many of whom are of working age and struggle with adherence due to the need to manage multiple comorbidities related to diabetes.

The Philippine Food and Drug Administration (FDA) has approved brolucizumab for the treatment of visual impairment due to diabetic macular edema (DME).

DME is a common microvascular complication in patients with diabetes that may have a debilitating impact on visual acuity, eventually leading to blindness. Consistently high blood sugar levels associated with diabetes can damage small blood vessels in the eye, causing them to leak fluid. This damage leads to an excess of vascular endothelial growth factor (VEGF).

VEGF is a protein that stimulates the growth of blood vessels. At elevated levels in DME, VEGF stimulates the growth of abnormal, leaky blood vessels. The resulting accumulation of fluid (known as edema) in the macula is a key marker of disease activity and can lead to vision loss. 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 recommended dose for Brolucizumab is 6 mg (0.05 mL) administered by intravitreal injection every 6 weeks for the first five doses. Thereafter, Brolucizumab is administered every 12 weeks (3 months). Treatment intervals should be determined by the physician and should be based on disease activity as assessed by visual acuity and/or anatomic parameters. In patients with disease activity, treatment every 8 weeks (2 months) could be considered.

“DME is the leading cause of visual impairment among the working population. Scientific evidence has demonstrated that for many patients, brolucizumab can be injected less frequently than current medications and still be effective. With this latest Philippine FDA approval of brolucizumab, clinicians not only have a powerful tool for preserving and restoring the vision of diabetic patients, we also now have a new means of reducing the heavy treatment burden for many Filipino patients,” said Dr. Harvey S. Uy, President, Vitreo-Retina Society of the Philippines (VRSP)

“At Novartis, our mission is to discover new ways to improve and extend people's lives. This approval marks a significant milestone for DME patients, many of whom are of working age and struggle with adherence due to the need to manage multiple comorbidities related to diabetes,” said Mr. Joel Chong, Country President, Novartis Healthcare Philippines.

The latest Philippine FDA approval was based on the 52-week results from the two-year phase III clinical studies KESTREL and KITE. Involving a total of 926 patients in 36 countries, KESTREL and KITE compared the safety and efficacy of brolucizumab and aflibercept in the treatment of patients with visual impairment due to DME. In August 2022, the Philippine FDA approved brolucizumab for the treatment of neovascular (wet) age-related macular degeneration (AMD), a major contributor to blindness in the country.