Regulatory Decision Summary for Beovu

Authorization was based on two randomized, double-masked, active-controlled non-inferiority Phase III studies (Study RTH258-C001 [HAWK] and Study RTH258-C002 [HARRIER]) in 1817 patients with wet AMD for 2 years. Patients received Beovu 3 mg (n = 358) or BEOVU 6 mg (n = 730), every 8 or 12 weeks based on the physicians judgment after the first 3 monthly doses. Other patients (n = 729) received aflibercept (an approved drug for wet AMD treatment) 2 mg every 8 weeks after the first 3 monthly doses. The primary efficacy benefit was assessed by measuring the change in best-corrected visual acuity (BCVA) at Week 48. After one year of treatment, patients treated with Beovu showed similar visual acuity improvement as patients treated with aflibercept.

Beovu may cause serious side effects including eye infection, eye inflammation, retinal detachment/tear, cataract, increase of the eye pressure, formation of blood clots in blood vessels and allergic reactions. The most common side effects identified are decreased visual acuity, cataracts, conjunctival bleeding, eye inflammation, eye floaters and eye pain.

Beovu is injected by a healthcare professional directly into the eye. The recommended dose is 6 mg (0.05 mL) every month for the first three months. After that, dosing is continued at 8 or 12 week dosing intervals per the physicians judgment.

Beovu is indicated for the treatment of wet AMD and provides an option for eligible patients at a reduced treatment frequency. The benefit/risk profile of Beovu is favourable in the target patient population. View the Beovu PM for more information.