Aflibercept biosimilar P041 has demonstrated comparable efficacy and safety to the originator aflibercept (Eylea) in treating patients with neovascular age-related macular degeneration (nAMD). The phase 3 randomized, double-masked active control trial, spanning 52 weeks, indicates that P041 could offer a more accessible and cost-effective treatment option for elderly patients with nAMD.
The study, published in American Academy of Ophthalmology, enrolled 168 patients with nAMD, randomly assigning them to either the P041 biosimilar or the reference product Eylea. Participants received intravitreal injections every four weeks for the first three doses, followed by injections every eight weeks until week 48. The primary outcome was the noninferiority of P041 compared to Eylea in maintaining vision at week 52.
Efficacy and Safety Outcomes
At week 52, 94.44% of patients in the P041 group and 94.52% in the Eylea group maintained their vision from baseline, demonstrating no significant difference between the two groups (difference, –0.0008; 95% CI, –0.074-0.074; P = .98). Secondary outcomes, including changes in visual acuity and retinal thickness, also showed no significant differences (P > .05). Best corrected visual acuity improved in both arms.
Adverse events were reported in 47 patients in the P041 group and 44 patients in the Eylea group. The most common ocular adverse event was injection site irritation, while rhinorrhea was the most frequently reported nonocular adverse event in both groups.
Implications for nAMD Treatment
Neovascular AMD, a leading cause of vision loss in the elderly, is characterized by choroidal neovascularization driven by vascular endothelial growth factor (VEGF). The reference product, Eylea, received FDA approval in November 2011 following positive results from the VIEW 1 and VIEW 2 studies.
The introduction of biosimilars like P041 and the recently approved aflibercept-yszy (Opuviz) and aflibercept-jbvf (Yesafili) offers a more affordable treatment option, particularly beneficial for elderly patients on fixed incomes. The study authors stated, "This phase 3 clinical trial showed P041 is noninferior to aflibercept in terms of maintaining vision. Other efficacy and safety outcomes were also similar between the 2 products through 52 weeks of the study."
Study Limitations
The study acknowledged disruptions due to the COVID-19 pandemic, which resulted in limited visitations and follow-up schedules for some patients. The validity of the data could be improved by evaluating images in an image reading center rather than by a research coordinator.
