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.