A secondary post hoc analysis of patients who had neovascular age-related macular degeneration (AMD) and were treated with intravitreal aflibercept or ranibizumab—2 widely used anti-vascular endothelial growth factor (anti-VEGF) therapies—found that those with certain characteristics had a substantial risk of conversion to AMD in the untreated eye.
A secondary post hoc analysis of patients who had neovascular age-related macular degeneration (AMD) and were treated with intravitreal aflibercept or ranibizumab—2 widely used anti-vascular endothelial growth factor (anti-VEGF) therapies—found that those with certain characteristics had a substantial risk of conversion to AMD in the untreated eye.
The study, published in Thursday in JAMA Ophthalmology, aimed to assess the association of the anti-VEGF medication and dosing regimen with the incidence of conversion to AMD in the other eye of patients treated with ranibizumab or intravitreal aflibercept injection (IAI). The study also sought to identify baseline characteristics influencing the incidence of conversion.
Researchers used randomized clinical trial data from the Vascular Endothelial Growth Factor Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) studies. The VIEW 1 and VIEW 2 studies were randomized, double-masked, active-controlled, multicenter, 96-week, phase 3 trials of IAI in 2457 patients with neovascular AMD who had not yet been treated.
The current study analyzed a subgroup of participants (n = 1561) treated for neovascular AMD in 1 eye who had untreated fellow eyes without neovascularization at baseline.
All participants in the prior studies were included in 1 of 4 groups: ranibizumab, 0.5mg, every 4 weeks; aflibercept, 2mg, every 4 weeks; aflibercept, 0.5mg, every 4 weeks; or aflibercept, 2mg, every 8 weeks after 3 injections at 4-week intervals.
The incidence of fellow eye conversion was 26.2% to 32.2% across treatment groups through week 96, and there was no difference in conversion rates across treatment groups. Patients received no treatment in the fellow eyes unless they had conversion to neovascular AMD.
Factors associated with higher risk of fellow eye conversion were increasing age, female sex, baseline intraretinal fluid in the study eye, and increasing choroidal neovascularization lesion size in the study eye.
Patients at high risk for conversion should be monitored closely, the researchers wrote.
At 96 weeks, 375 patients (24.0%) experienced cases of conversion to neovascular disease in the fellow eye, including:
The rates of conversion were 18.1, 16.2, 14.7, and 16.0 per 100 patient-years at risk at week 96, respectively.
On multivariate analysis, fellow eye conversion was associated with increasing patient age (per 10 years) at baseline (hazard ratio [HR], 1.20; 95%CI, 1.05-1.36), female sex (HR, 1.32; 95% CI, 1.06-1.63), intraretinal fluid in the study eye at baseline (HR, 1.28; 95% CI, 1.02-1.61), and increasing choroidal neovascularization lesion size (per 10mm2) in the study eye at baseline (HR, 1.29; 95% CI, 1.06-1.57).
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.