Ophthalmology & Visual Sciences at the Eye Institute

Ophthalmology and Visual Sciences

Vision Science Research Team Clinical Trial Participation Contributes to FDA Approval of New Drug

According to Novartis, on October 8, 2019, the U.S. Food and Drug Administration (FDA) approved Beovu® (brolucizumab) for intravitreal injection for the treatment of wet age-related macular degeneration (AMD). Beovu is part of the anti-VEGF class of drugs, which work by reducing swelling in the retina due to abnormally growing and leaking blood vessels. By reducing this retinal swelling, anti-VEGF agents can help to improve visual outcomes.

In two concurrent phase 3 clinical trials, Beovu® demonstrated greater retinal fluid resolution versus the currently FDA-approved aflibercept (Eylea®). Beovu® was also able to maintain patients on a 12-week dosing regimen without compromising efficacy, which may help to reduce the treatment burden for patients diagnosed with wet AMD.

The approval of Beovu® was based on findings from the Phase III HAWK and HARRIER clinical trials. The Medical College of Wisconsin participated in the HAWK study, with a total of 408 sites participating in HAWK and HARRIER study worldwide. Overseen by local principal investigator, Dr. William Wirostko, professor of ophthalmology, and lead study coordinator, Katie McKenney, MCW enrolled 5 participants who were seen at the Eye Institute monthly for 2 years, with some participants completing an extra 6-month extension study.

MCW will soon be participating in another Novartis trial investigating the safety and efficacy of the same drug in patients with central retinal vein occlusion, a condition associated with reduced vision caused by the blockage of a retinal blood vessel.