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Phase 3 trials to focus on Port Delivery System for AMD, faricimab for DME
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Genentech and Roche announced the initiation of three large phase 3 clinical trials evaluating the Port Delivery System with ranibizumab to treat wet age-related macular degeneration and faricimab to treat diabetic macular edema, according to company correspondence.
The Port Delivery System is a refillable eye implant that continuously releases a formulation of ranibizumab over a period of several months. The delivery system will be evaluated in the phase 3 Archway study, the first phase 3 trial with a device used for the sustained delivery of an anti-VEGF therapy. The trial will evaluate the delivery system for the treatment of wet AMD using fixed interval dosing, with the primary endpoint being the change from baseline in best corrected visual acuity over weeks 36 to 40.
Faricimab is a bispecific antibody designed for the treatment of retinal eye disease that binds to and inactivates VEGF-A and Ang-2. The phase 3 YOSEMITE and RHINE trials will evaluate the safety and efficacy of faricimab for the treatment of DME compared with aflibercept injection. The studies will include 1,200 patients randomly assigned to one of three arms; the first will receive faricimab every 8 weeks or sham injections, the second will receive personalized treatment in which patients are dosed according to the study protocol or sham injections, and the third will receive aflibercept every 8 weeks or sham injections.
Perspective
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Judy E. Kim, MD
Development of anti-VEGFs has revolutionized our management of patients with neovascular age-related macular degeneration, diabetic macular edema and other vascular diseases by improving vision or markedly slowing down the worsening. Nevertheless, in my opinion, there are still a number of important unmet needs in management of these conditions. One such area is the heavy treatment burden. In many patients, intravitreous injections need to be given as often as every month. Even when the patient does not need to be treated monthly, continuous frequent follow-up is needed to detect recurrences as early as possible. Furthermore, the real-world data show that our patients do not gain as much visual acuity with anti-VEGF treatments compared with the pivotal clinical trial outcomes, thought to be due to undertreatment. In the “real world,” long-term frequent follow-up visits and treatments may be difficult for many patients due to various barriers. In addition, every intravitreous injection carries small but potential risks, including endophthalmitis and IOP elevation. Therefore, developing drugs that have longer durable effect in the eye and/or drug delivery mechanism that allows sustained drug delivery is important. This is why I am quite excited about the phase 3 clinical trials investigating faricimab in DME and the Port Delivery System (PDS) with ranibizumab in neovascular AMD. Faricimab can attack two different pathways in angiogenesis, which may be better than addressing only the VEGF pathway. While the initial implantation of PDS needs to be performed in the operating room, the refill of the drug can be performed in the office. This method of delivery has a potential of not only reducing the number of injections but also avoiding undertreatment. If either or both studies show efficacy and safety, it will be a significant step toward improving treatment burden and visual outcome for our patients.
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