Genentech Unveils New Clinical Data For the First Eye Implant for Wet AMD
Genentech announced positive topline results from the phase 2 LADDER study evaluating the efficacy and safety of its investigational Port Delivery System (PDS) with ranibizumab in people with wet age-related macular degeneration (AMD).
The small, refillable eye implant, which is slightly longer than a grain of rice, is designed to allow people with wet AMD to go several months without needing to visit their ophthalmologist for treatment.
“In the study, we found that a majority of patients were able to go 6 months or longer between their initial implant and their first refill of the device, and in the highest dose of the study, 80% of patients went 6 months or longer,” Anne Fung, MD, Associate Group Medical Director, Genentech Ophthalmology Medical Affairs, said in an interview with Eyewire News. “Furthermore, we were very pleased to see that the vision gains in the study were comparable between the highest dose of the PDS and our ranibizumab monthly therapy arm.”
The data were presented by Carl C. Awh, MD, of Tennessee Retina in Nashville, at the 36th Annual Meeting of the American Society of Retina Specialists (ASRS) in Vancouver, British Columbia, Canada.
“If the PDS is successful, it could have a major impact on the way we treat people with wet AMD,” Carl D. Regillo, MD, FACS, Chief of Retina Service at Wills Eye Hospital in Philadelphia, and investigator for the LADDER study, said in a company news release. “I believe that more consistent treatment could allow for better long-term vision outcomes in clinical practice.”
The current standard of care for wet AMD can be burdensome because it requires patients to visit their ophthalmologist as often as monthly for eye injections of anti-vascular endothelial growth factor (VEGF) therapy to help maintain vision gains and/or prevent vision loss. This high treatment burden with anti-VEGF therapy can lead to under-treatment of wet AMD and, potentially, less than optimal vision outcomes, according to Genentech.
“LADDER is the first successful phase 2 study of a long-acting delivery device for the treatment of wet AMD. We are highly encouraged by these results and the potential of the PDS, our first implantable, drug delivery program,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “With the PDS, we have an opportunity to make a positive impact by helping to potentially eliminate the burden of frequent treatments for people with wet AMD.”
LADDER study patients implanted with the PDS received one of three concentrations of ranibizumab: 10 mg/mL, 40 mg/mL or 100 mg/mL. For PDS patients receiving the 100 mg/mL dose (n=59), approximately 80 percent were able to go 6 months or longer until their first refill was required. Of the PDS patients receiving the 40 mg/mL (n=62) or the 10 mg/mL (n=58), 71.3 percent and 63.5 percent respectively, were able to go 6 months or longer before their first refill.
Secondary endpoints of the study included assessments of vision and anatomic outcomes when compared to monthly intravitreal ranibizumab 0.5 mg injections. Patients in the PDS 100 mg/mL arm achieved similar gains in Best Corrected Visual Acuity (BCVA) and similar reductions in central retina thickness compared to patients receiving monthly ranibizumab 0.5 mg injections.
The PDS is implanted during a surgical procedure. It is refilled using a customized needle in a minimally invasive office-based procedure. The results from this study will help determine the most appropriate dose and fixed treatment interval to study in the phase 3 program to sustain optimal vision outcomes in clinical practice for patients with wet AMD.
Additional data analyses of the LADDER study are ongoing and will be presented at future medical meetings. The PDS phase 3 clinical development program is expected to begin later in 2018.