CHMP Recommends EU Approval of Roche's Susvimo, First Continuous Delivery Treatment for Neovascular AMD
核心洞察
The CHMP has recommended EU approval of Roche's Susvimo (Port Delivery System with ranibizumab), the first continuous delivery treatment for neovascular age-related macular degeneration (搜索) (nAMD).
Seven-year follow-up data from the PDS clinical program, the longest in any wet AMD trial, show sustained vision gains with minimal decline in best-corrected visual acuity over time.
The Port Delivery System uses a refillable implant that delivers ranibizumab via zero-order kinetics for at least six months, reducing the burden of frequent intravitreal injections.
The Committee for Medicinal Products for Human Use (CHMP) has recommended European Union approval of Roche's Susvimo, marking a significant regulatory milestone for the first continuous delivery treatment for neovascular age-related macular degeneration (搜索) (nAMD). The recommendation positions Susvimo—a Port Delivery System (PDS) with a customized formulation of ranibizumab—to become available across the EU, potentially transforming the treatment paradigm for millions of patients affected by this leading cause of vision loss.
The CHMP recommendation is supported by the longest follow-up dataset from any wet AMD clinical trial program to date. At the Retina World Congress 2026, held May 14 to 17 in Fort Lauderdale, Florida, Carl D. Regillo, MD, FACS, director of the Retina Service at Wills Eye Hospital and professor of ophthalmology at Thomas Jefferson University, presented seven-year outcomes from the PDS clinical program.
Long-Term Efficacy and Safety Profile
The seven-year dataset draws from the original phase 2 LADDER trial (NCT02510794), in which patients were implanted with PDS, as well as the control arm that subsequently rolled over to receive PDS as part of the PORTAL extension program (NCT03683251). Regillo highlighted that when comparing PDS with real-world anti-VEGF biologic injections over an extended timeframe, PDS "clearly outperforms," with patients maintaining vision gains through the maintenance phase and demonstrating very little decline in best-corrected visual acuity over the course of seven years.
On safety, Regillo noted that most adverse events occur around the time of surgery or shortly thereafter, and that over time these become less frequent. "It's comforting to know that we have seven years of follow-up that we can tell patients what to expect having this device," he said.
How the Port Delivery System Works
The Contivue devices, specifically engineered for use with Susvimo, include a refillable implant surgically inserted into the eye during a one-time, outpatient procedure. The system also includes four ancillary devices to initially fill, insert, refill, and remove the implant. Susvimo delivers a customized formulation of ranibizumab—a VEGF inhibitor designed to bind to and inhibit VEGF-A (搜索)—over time using zero-order-like kinetics for at least six months. This customized formulation differs from the ranibizumab intravitreal injection marketed as Lucentis.
Patient Selection and Clinical Implications
Regillo identified the strongest candidates for PDS as those requiring frequent treatment to adequately control their wet AMD, as well as patients who have difficulty getting to the office for timely injections or experience significant anxiety or discomfort associated with injections. He described patients receiving injections every 4, 6, or 8 weeks as "clearly the sweet spot" for PDS candidacy, while noting that patients well controlled on injections every three to four months may be less inclined to pursue the device.
Broader Implications for Sustained Delivery
The PDS program demonstrates that continuous zero-order delivery is "really the best way to control wet AMD and frankly probably most of our common retinal diseases" managed with anti-VEGF therapy, Regillo stated. He noted that PDS is now FDA-approved in the United States for wet AMD, diabetic retinopathy (搜索), and diabetic macular edema (搜索). The long-term safety data from the PORTAL program also provides a model for evaluating other sustained delivery approaches, including bioerodible inserts with tyrosine kinase inhibitors and gene therapy.
Roche is evaluating other molecules in its pipeline that could potentially be used with the Port Delivery Platform to increase efficacy and/or durability, with the future aim of providing multiple treatment options to patients using Contivue. "We're clearly going in the direction of sustained delivery in general to manage wet AMD in the maintenance phase," Regillo concluded.
Disease Burden
Neovascular AMD is an advanced form of age-related macular degeneration that can cause rapid and severe vision loss if left untreated. It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding, and/or fibrosis. Worldwide, approximately 20 million people are living with nAMD, which is the leading cause of vision loss in people over the age of 60, and the condition is expected to affect even more people as the global population ages.