Novartis announced that results of two new post-hoc analyses of the phase 3 HAWK and HARRIER clinical trials in wet age-related macular degeneration (AMD) were presented at the Euretina 2020 virtual congress.
The first analysis demonstrated fewer Beovu (brolucizumab) patients had early persistent fluid, defined as the presence of intra-retinal fluid and/or sub-retinal fluid through week 12 of treatment, compared with aflibercept patients.1 For patients who did have early persistent fluid, those treated with Beovu achieved greater best-corrected visual acuity (BCVA) gains and greater reductions in central subfield thickness (CST) at week 96 versus those treated with aflibercept, according to a company news release.
A second analysis showed Beovu was associated with better control of retinal fluid, as measured by achievement and maintenance of defined CST levels. In the study, more Beovu patients than aflibercept patients achieved CST control (80% vs. 69% at week 96 at a defined CST threshold of 320 µm, respectively).2 Patients who stayed longer in a controlled CST state had better visual gains compared with those who remained in an uncontrolled CST state. CST is a key indicator of fluid in the retina, and drying the retina is a core aim of treatment for wet AMD.2
“The data presented at Euretina suggests Beovu can better help patients who have persistent retinal fluid achieve disease control by reducing CST and improving their vision in the long term,” Dirk Sauer, Global Head Development, Novartis Pharma Ophthalmology, said in the news release. “These results further strengthen our confidence in Beovu as an effective and important treatment option for wet AMD patients aiming to improve their vision.”
- Lally D. An assessment of BCVA and CST outcomes with brolucizumab and aflibercept in patients with early persistent retinal fluid: 96 week pooled data from HAWK and HARRIER. Presented at: EURETINA 2020 congress. October 2020.
- Singh RP, et al. Multi-State Model Analysis of Central Subfield Thickness with Brolucizumab and Aflibercept in Neovascular Age-related Macular Degeneration: 96 week pooled data from HAWK and HARRIER. Presented at: EURETINA 2020 Congress. October 2020.