In data presented at AAO, investigators find BI 836680 shows early signals of bioactivity.
Initial research from a poster presented at the American Academy of Ophthalmology (AAO) 2020 Conference shows a new combination agent could be beneficial in treating patients with wet age-related macular degeneration (wet AMD).
A team, led by Dr. Oliver Zeitz, Charité - Universitätsmedizin Berlin, assessed the safety and bioactivity of BI 836880, an anti-VEGF/ anti-angiopoietin-2 (Ang2) agent with an albumin-binding domain for half-life extension in an ongoing open-label, single rising dose study.
BI 836880 is an aimed at increasing the efficacy of treatment in wet AMD patients whose disease continues to progress despite at least 3 prior anti-VEGF injections.
The patients included in the study were diagnosed with wet AMD who remained active despite at least 3 anti-VEGF injections. The researchers thus far completed 3 dose cohorts in Germany and the UK where a single intravitreal injection of BI 836880 was given to 3 patients in each cohort. Each patient was followed up for at least 43 days.
The mean age of the patient population was 77.9 years old and the mean baseline best corrected visual acuity (BCVA) in the study eye was 56.0 (1.7), 53.7 (19.7) and 52.0 (18.0) letters (Snellen equivalent of approximately 20/80) in Cohorts 1-3, respectively.
The mean BCVA change from baseline to the conclusion of the trial in the study eye was +5.3 (3.1), +7.3 (3.8) and +0.3 (6.1) letters in Cohorts 1 to 3, respectively. There were no dose-limiting event or drug-related severe adverse events found in the patient population. Some of the ocular adverse events included dry eye (n = 1), conjunctival hemorrhage (n = 1), occurrence of choroidal neovascularization (CNV) (n = 1), and worsening of exudation in the study eye (n = 1).
However, retinal thickness reductions were observed by the investigators.
“BI 836880 was well tolerated and showed early signals of bioactivity,” the authors wrote. These initial results support further investigation of BI 836880 in patients with wAMD.”
Part 2 of the trial will investigate multiple rising doses of the study drug.
A team, led by Assaf Hilely, Division of Ophthalmology, Tel Aviv Ichilov-Sourasky Medical Center, evaluated the various patterns of subretinal fluid in eyes with AMD in the absence of macular neovascularization (MNV), while assessing the long-term outcomes in these eyes.
In the retrospective study, the investigators examined eyes with non-neovascular AMD and associated SRF and excluded eyes with evidence of MNV. The research team obtained spectral-domain optical coherence tomography (SD-OCT) at baseline and at follow-up.
The investigators found 3 different morphologies of subretinal fluid—crest of fluid over the apex of the drusenoid PED, pocket of fluid at the angle of a large druse or in the crypt of confluent drusen or drape of low-lying fluid over confluent drusen. More than half (n = 27) of the 45 eyes with fluid displayed collapse of the associated druse or drusenoid PED, while 24 eyes developed evidence of complete or incomplete retinal pigment epithelial and outer retinal atrophy.
The study, “Phase 1 Study of Intravitreal BI 836880 in Previously Treated Patients With Wet AMD,” was published AAO 2020.