Brolucizumab Is Noninferior to Aflibercept, But Has Higher Incidence of Inflammation

Although a brolucizumab trial met all efficacy end points, it showed a higher incidence of intraocular inflammation than aflibercept.

Brolucizumab (BRO) met all efficacy end points in a trial comparing the anti-vascular endothelial growth factor (anti-VEGF) injection with aflibercept (AFL), according to a poster presented at the 2022 annual meeting of the American Academy of Ophthalmology (AAO), held in Chicago September 30 to October 3. However, patients in the BRO group had a higher incidence of intraocular inflammation (IOI) and retinal vein occlusion than the patients in the AFL. 

This 104-week Phase 3a ‘Patients With Neovascular Age-related Macular Degeneration (nAMD) With Persistent Retinal Fluid (MERLIN) study (ClinicalTrials.gov Identifier: NCT03710564) assessed the efficacy and safety of eyes randomly assigned treatment with eitherBRO 6 mg or AFL 2 mg (2:1). The injections were administered every 4 weeks in eyes with neovascular AMD (nAMD) and persistent fluid despite prior anti-VEGF therapy. 

The trial was terminated early due to a safety signal uncovered at week 52, the report shows. Treatment of 29.2% and 30.7% BRO and AFL eyes, respectively, were discontinued in year 2 due to the early termination. 

At week 52, BRO demonstrated continued noninferiority in mean best corrected visual acuity change (P <.002) and superiority (P <.002) in mean change in both central subfield thickness and fluid-free status when compared with AFL.

However, incidences of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion were higher for patients in the BRO group 11.5% (1.1%) and 2.2% vs 6.1% (0%) and 0.6% for AFL, respectively.

References:

Brown, D, Jaffe, G. Wykoff, C. MERLIN: Two-year results from the phase 3a trial of Brolucizumab in participants with nAMD and persistent retina fluid. Poster presented at: The American Academy of Ophthalmology 2022 Annual Meeting; September30 to October 3, 2022; Chicago. Abstract PO370.