Real-World Results Show Sustainability, Safety of Faricimab

BARCELONA, Spain — Early findings from a real-world study of the dual-action antibody faricimab have shown sustained improvement in visual acuity and key biomarkers of retinal anatomy, with no new safety concerns in people with two of the most prevalent retinal diseases who had not had previous treatment for the conditions.

Clare Bailey, MD, MRCP, a consultant ophthalmologist at Bristol Eye Hospital in Bristol, England, presented 6-month results from the VOYAGER trial on September 20 at European Society of Retina Specialists (EURETINA) 2024. The trial aims to report 5-year outcomes of 5000 patients with neovascular, or wet, age-related macular degeneration (nAMD) and diabetic macular edema (DME) receiving faricimab (Vabysmo). The study includes patients who have and have not received previous treatments for either condition, but Bailey’s research focused on the latter group.

“This early date presentation demonstrates good responses in terms of visual acuity and anatomical outcomes for treatment-naive nAMD and DME eyes between baseline and month 6,” Bailey told Medscape Medical News.

The early results showed visual acuity improved by 3.5 Early Treatment Diabetic Retinopathy Study letters in nAMD and 7.2 letters in eyes with DME, Bailey said. By comparison, the phase 3 TRUCKEE study reported an improvement in visual acuity of 1.1 letters in treatment-naive eyes with nAMD at 6 months.

Faricimab is an antibody injected into the eye that targets two causes of macular degeneration or edema in exudative retinal disease: Angiopoietin-2 and vascular endothelial growth factor (VEGF) A. Previous-generation intravitreal anti-VEGF agents target only VEGF. The European Commission and the US Food and Drug Administration (FDA) approved faricimab for nAMD and DME in 2022.

Evaluating Anatomical Improvements

VOYAGER investigators are collecting data from optical coherence tomography (OCT) “so that detailed anatomical findings will be presented in due course,” Bailey said. OCT imaging will evaluate anatomical biomarkers, namely retinal thickness, known as central subfield thickness; fluid under the retina (subretinal fluid); and fluid within the retinal layer itself (intraretinal fluid). Increasing retinal thickness and fluid signal advancing disease in these patients.

“There were early anatomical improvements with improvements in central subretinal fluid and also the sensitive eyes with subretinal fluid and intraretinal fluid reducing between baseline and month 6,” Bailey said.

Bailey reported on 119 eyes with nAMD and 51 with DME. In the eyes with nAMD, central subfield thickness declined by 85.1 μm on average. At baseline, 69.8% of eyes had subretinal fluid, as determined by a physician, vs 25.9% at 6 months, and 62.7% had intraretinal fluid vs 15.8% at 6 months. Patients had an average of 4.7 injections over the 6-month period.

In patients with DME, Bailey said, the 6-month results were more robust. In addition to the 7.2-letter gain, average central subfield thickness declined by 150.4 μm. At baseline, 29.8% had physician-determined subretinal fluid vs 3.7% at 6 months, and 98.2% had intraretinal fluid vs 72.7% at 6 months. Again, the average patient received 4.7 injections.

No New Safety Concerns

The real-world results so far have demonstrated no new safety concerns compared with the clinical trials, Bailey added. Adverse events associated with faricimab include cataracts, conjunctival hemorrhage, eye infections, and a temporary increase in intraocular pressure. The medication also has been linked to rare instances of blood clots as well as cases of retinal vasculitis and/or retinal vascular occlusion, according to Genentech, which manufactures the product.

José García-Arumí, MD, professor and coordinator of ophthalmology at the University of Barcelona, Barcelona, Spain, and moderator of the EURETINA session at which Bailey presented her results, noted the importance of the safety findings.

“I think a very important study because we know that all the results of the pivotal three studies that showed very good safety and effectiveness of faricimab, but it’s very important to know in the real life because with other drugs it has been very different in real life than the pivotal studies,” García-Arumí said.

That was a veiled reference to the complement inhibitor pegcetacoplan (Syfovre) for treatment of geographic atrophy. In 2023, 6 months after the FDA approved the drug, the American Society of Retina Specialists issued a warning to members about cases of vasculitis from the treatment, which had not been seen in clinical trials of the drug.

Bailey said the study is scheduled to conclude in 2027.

Bailey is a consultant to Roche. García-Arumíhad no disclosures.

Richard Mark Kirkner is a medical journalist based in the Philadelphia area.