Medication Monitor

Generic Name (Trade Name—Company)
October 30, 2019


FDA approves new treatment for age-related macular degeneration

On October 8, Novartis announced FDA approval of brolucizumab injection to treat wet age-related macular degeneration (AMD). According to Novartis, it is the first FDA-approved anti–vascular endothelial growth factor to offer greater fluid resolution than aflibercept and the ability to maintain patients with AMD on a 3-month dosing interval immediately after a 3-month loading phase, with uncompromised efficacy.

Approval was based on findings from the Phase III HAWK and HARRIER clinical trials, in which brolucizumab demonstrated noninferiority to aflibercept in mean change in best-corrected visual acuity at year one (week 48).

In both clinical trials, approximately 30% of patients gained at least 15 letters at year one. In HAWK and HARRIER, patients receiving brolucizumab showed greater reduction in central subfield thickness as early as week 16, and at year one, fewer patients had intra-retinal and/or subretinal fluid. Retinal fluid is a key marker of disease activity.

The most common adverse events are blurred vision, cataract, conjunctival hemorrhage, vitreous floaters, and eye pain.