Why do we need another drug for wet age-related macular degeneration (AMD)? There are two good reasons: efficacy and duration. Despite even monthly treatment, a large proportion of patients with wet AMD still have fluid on optical coherence tomography (OCT). The search has therefore continued for a more efficacious drug that also lasts longer in the eye.
Brolucizumab (Beovu), recently approved by the US Food and Drug Administration, may be the drug that meets these clinical needs. A single-chain antibody fragment that inhibits vascular endothelial growth factor (VEGF)-A, brolucizumab's molecular design has the opportunity to penetrate tissue better (being smaller in size) and have a higher molar concentration.
After the OPSREY phase 2 trial showed brolucizumab's safety and efficacy, the HAWK and HARRIER phase 3 trials were undertaken to assess whether it was noninferior to aflibercept. Patients with untreated AMD participating in the trials were randomly assigned to loading doses of brolucizumab (3 or 6 mg) or aflibercept (2 mg) at weeks 0, 4, and 8.
The trial design differed with what we are used to seeing with other AMD trials, in that it represented a real-world clinical situation. Patients in the aflibercept arms received injections every 8 weeks, whereas those in the brolucizumab arms were scheduled to receive injections every 8 or 12 weeks.
