Genentech announced positive topline results from the phase 3 Archway study, evaluating Port Delivery System with ranibizumab (PDS) in people living with wet age-related macular degeneration (AMD). PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customized formulation of ranibizumab over a period of months. The Archway trial met its primary endpoint, demonstrating that patients with PDS who received refills every 6 months achieved visual acuity outcomes equivalent to those receiving monthly ranibizumab 0.5 mg injections. In Archway, PDS was generally well-tolerated with a favorable benefit-risk profile.
“For people around the world receiving frequent eye injections for neovascular AMD, this continuous delivery system could greatly reduce their treatment burden,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development, said in a company news release. “We look forward to presenting detailed Archway results at future medical meetings and discussing these data with regulatory authorities, with the aim of bringing this new treatment option to patients as soon as possible.”
In addition to Archway, the Portal study is investigating the long-term safety and tolerability of PDS for the treatment of wet AMD. Furthermore, PDS is also being studied in the Pagoda trial for the treatment of diabetic macular edema (DME).
Full results from the Archway study will be presented at an upcoming medical meeting and submitted to health authorities around the world, including the FDA and European Medicines Agency, for consideration of regulatory approval for the treatment of wet AMD.
About the Archway Study[vi]
Archway (NCT03677934) is a randomized, multicenter, open-label phase 3 study evaluating the efficacy and safety of Port Delivery System with ranibizumab (PDS), refilled every 6 months at fixed intervals, compared to monthly intravitreal injections of ranibizumab 0.5 mg in 418 people living with wet age-related macular degeneration (AMD). The primary endpoint of the study is the change in best-corrected visual acuity (BCVA) score from baseline at the average of week 36 and week 40. Secondary endpoints include safety; overall change in BCVA from baseline; and change from baseline in center point thickness over time.
[i] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures. Available at:https://www.brightfocus.org/macular/article/age-related-macular-facts-figures. Accessed May 2020.
[ii] Holz FG, Tadayoni R, Beatty S, et al. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. British Journal of Ophthalmology. 2015;99:220-226.
[iii] Rao P, Lum F, et al. Real-World Vision in Age-Related Macular Degeneration Patients Treated with Single Anti–VEGF Drug Type for 1 Year in the IRIS Registry. Ophthalmology. 2018; 125: 522-528.
[iv] ClinicalTrials.gov. Extension Study for the Port Delivery System With Ranibizumab (Portal). Available at:https://clinicaltrials.gov/ct2/show/NCT03683251. Accessed May 2020.
[v] ClinicalTrials.gov. This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab (Pagoda). Available at: https://clinicaltrials.gov/ct2/show/NCT04108156. Accessed May 2020.
[vi] ClinicalTrials.gov. A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration (Archway). Available at: https://clinicaltrials.gov/ct2/show/NCT03677934. Accessed May 2020.
[vii] BrightFocus Foundation. Macular Degeneration: Essential Facts. Available at: http://www.brightfocus.org/macular/news/macular-essential-facts. Accessed May 2020.
[viii] Wykoff CC, et al. Optimizing anti-VEGF treatment outcomes for patients with neovascular age-related macular degeneration. Journal of Managed Care & Specialty Pharmacy, 2018; 24(2-a Suppl):S3-S15.