A study to assess safety and efficacy of a small, refillable eye implant, designed to deliver ranibizumab to people with wet age-related macular degeneration (AMD), has shown positive outcomes according to Genentech, a member of the Roche Group.
The Port Delivery System (PDS), 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.
If the PDS is successful, it could have a major impact on the way we treat people with wet AMD
The majority of PDS patients enrolled in the Phase II LADDER trial went six months or longer between implant of the device and the first, required refill. Vision outcomes in the high-dose PDS group were similar to monthly ranibizumab eye injections and were maintained throughout the study period. These data were presented by Carl C. Awh, M.D., of Tennessee Retina in Nashville, TN, at the 36th Annual Meeting of the American Society of Retina Specialists (ASRS) in Vancouver, British Columbia, Canada.1
“If the PDS is successful, it could have a major impact on the way we treat people with wet AMD,” said Dr. Regillo, Chief of Retina Service at Wills Eye Hospital in Philadelphia, PA and investigator for the LADDER study. “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.2,3
“LADDER is the first successful Phase II 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 Dr. Sandra Horning, 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 per cent were able to go six 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 per cent and 63.5 per cent respectively, were able to go six 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 customised 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 III program to sustain optimal vision outcomes in clinical practice for patients with wet AMD.
Additional data analyses of the LADDER study are on-going and will be presented at future medical meetings. The PDS Phase III clinical development program is expected to begin later this year.
1. LADDER Trial of the Port Delivery System for Ranibizumab: Preliminary Study Results. Presented by Awh, C on July 25, 2018 during the Late Breaking Abstract session at the 36th Annual Meeting of the American Society of Retina Specialists (ASRS) in Vancouver, British Columbia, Canada.
2. 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.
3. 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