Results from a French brolucizumab access program for pretreated patients with neovascular age-related macular degeneration

Abstract

Purpose

Following European Medicines Agency (EMA) approval, France implemented a managed access program (MAP) to provide brolucizumab to patients with neovascular age-related macular degeneration (nAMD) who lacked treatment alternatives. The French MAP data analysis evaluated efficacy and safety of brolucizumab in brolucizumab-naïve patients.

Methods

Of 599 patients enrolled between February 2022 and January 2024, 360 pretreated with anti-VEGF therapy but brolucizumab-naïve were assessed at baseline for clinical and anatomical benefits of brolucizumab in a close-to-real-world setting.

Results

After 18 months, patients received a median of eight injections, maintaining visual acuity and achieving a mean central subfield macular thickness (CSMT) reduction of −92.0 µm among those with baseline CSMT ≥300 µm. Intraretinal fluid, subretinal fluid, and pigment epithelial detachment occurred in 32.8%, 75.3%, and 61.7% patients at baseline, and 16.5%, 47.0%, and 51.3% patients at 18 months. Patients previously requiring Q4 or Q5–Q7 injections successfully extended their intervals to Q8 or longer. Intraocular inflammation rate was 8.0% (n = 29).

Conclusion

Results demonstrated functional and anatomical benefits of brolucizumab in patients with refractory or suboptimally controlled nAMD, with a manageable safety profile. These findings highlight the potential of brolucizumab to reduce treatment burden in chronic nAMD.