Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
Ranibizumab port delivery system for neovascular age-related macular degeneration: Current evidence and surgical considerations.
СтатьяОбзорНазвание и аннотация: Перевод в очереди
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Quarta Alberto, Sivaprasad Sobha, Wong Tien Y, Lanzetta Paolo, Wykoff Charles C, Mastropasqua Rodolfo, Sadda Srinivas R
Аннотация
PURPOSE: To review the engineering principles, pharmacokinetics, clinical evidence, surgical considerations, safety profile, and emerging real-world implications of the ranibizumab Port Delivery System (PDS) as a sustained intraocular drug-delivery platform for neovascular age-related macular degeneration.
METHODS: A systematic literature search was conducted to identify peer-reviewed publications addressing implant engineering, molecular compatibility, pharmacokinetics, phase 1-3 trials (LADDER, ARCHWAY, PORTAL), extension studies, perioperative management, safety outcomes, health-economic analyses, and patient-reported outcomes related to the ranibizumab PDS.
RESULTS: Phase 2 and 3 trials demonstrated that PDS delivering ranibizumab 100 mg/mL with fixed 24-week refill intervals achieved visual and anatomic outcomes noninferior to monthly intravitreal injections, with approximately 95% of patients not requiring supplemental treatment before scheduled refills. Pharmacokinetic studies confirmed sustained intraocular drug exposure within the therapeutic window of monthly dosing. Long-term extension data support durability through multi-year follow-up. The distinct safety profile features implant- and conjunctival interface events, including conjunctival erosion, vitreous hemorrhage, and device-associated endophthalmitis, underscoring the importance of surgical technique and postoperative surveillance. Economic analyses indicate cost parity with branded anti-VEGF agents under high injection frequencies, while patient-reported outcomes consistently demonstrate strong preference for sustained delivery. In ARCHWAY, mean BCVA change averaged over Weeks 36/40 was + 0.2 letters with PDS versus + 0.5 letters with monthly ranibizumab, and 98.4% of PDS-treated eyes required no supplemental injections in the first 24-week interval; across later intervals, approximately 95% avoided supplemental treatment before scheduled refill.
CONCLUSIONS: The ranibizumab PDS establishes sustained intraocular anti-VEGF delivery as a viable alternative to anti-VEGF injections especially in patients requiring frequent dosing. Its long-term role will depend on optimization of surgical workflows, management of implant-specific risks, integration of monitoring strategies, and ongoing refinement of device design to support scalable, durable retinal care.
METHODS: A systematic literature search was conducted to identify peer-reviewed publications addressing implant engineering, molecular compatibility, pharmacokinetics, phase 1-3 trials (LADDER, ARCHWAY, PORTAL), extension studies, perioperative management, safety outcomes, health-economic analyses, and patient-reported outcomes related to the ranibizumab PDS.
RESULTS: Phase 2 and 3 trials demonstrated that PDS delivering ranibizumab 100 mg/mL with fixed 24-week refill intervals achieved visual and anatomic outcomes noninferior to monthly intravitreal injections, with approximately 95% of patients not requiring supplemental treatment before scheduled refills. Pharmacokinetic studies confirmed sustained intraocular drug exposure within the therapeutic window of monthly dosing. Long-term extension data support durability through multi-year follow-up. The distinct safety profile features implant- and conjunctival interface events, including conjunctival erosion, vitreous hemorrhage, and device-associated endophthalmitis, underscoring the importance of surgical technique and postoperative surveillance. Economic analyses indicate cost parity with branded anti-VEGF agents under high injection frequencies, while patient-reported outcomes consistently demonstrate strong preference for sustained delivery. In ARCHWAY, mean BCVA change averaged over Weeks 36/40 was + 0.2 letters with PDS versus + 0.5 letters with monthly ranibizumab, and 98.4% of PDS-treated eyes required no supplemental injections in the first 24-week interval; across later intervals, approximately 95% avoided supplemental treatment before scheduled refill.
CONCLUSIONS: The ranibizumab PDS establishes sustained intraocular anti-VEGF delivery as a viable alternative to anti-VEGF injections especially in patients requiring frequent dosing. Its long-term role will depend on optimization of surgical workflows, management of implant-specific risks, integration of monitoring strategies, and ongoing refinement of device design to support scalable, durable retinal care.