Abicipar maintains vision gain in wet AMD with less frequent dosing
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Visual gains attained in year 1 of the CEDAR and SEQUOIA trials sustained effectively with four injections of abicipar as with 12 injections of ranibizumab in year 2, according to data from the virtual American Society of Retina Specialists meeting.
Further, mathematical model simulations predicted longer duration of treatment effect.
The CEDAR and SEQUOIA studies demonstrated that abicipar pegol, either at 8-week or 12-week dosing intervals, was noninferior to ranibizumab given monthly in terms of stable visual acuity, and mean change in vision and central retinal thickness, according to Peter K. Kaiser, MD, of the Cole Eye Institute at Cleveland Clinic.
In this study, researchers reported 2-year CEDAR/SEQUOIA data and model simulations of visual outcomes for abicipar pegol to treat neovascular AMD.
“The goal of this study was to use a population-based, pharmacokinetic/pharmacodynamic (PK/PD) model using the visual acuity from the phase 3 data to allow us to look at the PK and PD of the patients to predict what an extending dosing schedule could possibly evaluate in these patients, so a [16-week] or [20-week] dosing interval,” he explained.
At week 104, the model yielded comparable percentages across arms regarding stable vision (abicipar Q8: 93% [n = 426]; Q12: 90% [n = 422] vs. ranibizumab Q4: 94% [n = 498]), mean changes in BCVA (abicipar Q8: 7.8 letters; abicipar Q12: 6.1 letters vs. ranibizumab Q4: 8.5 letters), and central retinal thickness (abicipar Q8: –147 µm; abicipar Q12: –146 µm vs. ranibizumab Q4: –142 µm), according to the abstract.
Kaiser and colleagues also reported that the abicipar groups maintained visual gains and improved anatomical changes while requiring fewer injections compared with ranibizumab (abicipar Q8: n = 14; abicipar Q12: n = 10 vs. ranibizumab Q4:P n = 25).
The mathematical model predicted the proportion of patients with a visual acuity change of at least 5 letters (abicipar Q8: 62%; Q12: 55.1%; Q16: 47.6%; Q20: 36.5%), according to the presentation. The groups also demonstrated similar rates of treatment-emergent adverse events at the end of the second year.
“Using our model, we predicted roughly a 5 letter mean change in visual acuity at week 52 and week 104 using a 16-week dosing interval and a slightly lower 4.7 and 3.5 mean improvement of visual acuity using [20]-week dosing,” Kaiser said. “We hope to get this drug in our hands shortly to be able to test this mathematical model in patients.”
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Kaiser PK, et al. Clinical Evaluation and PK/PD Modeling of the DARPin Therapeutic Abicipar for the Treatment of Neovascular AgeRelated Macular Degeneration. Presented at: American Society of Retina Specialists annual meeting; July 24-26, 2020 (virtual meeting).
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