After 6 months, 80% of those implanted with the 100 mg/mL dose of ranibizumab still did not need a medication refill.
Carl C. Awh, MD
Positive top-line results from the phase 2 LADDER study, which evaluated the safety and efficacy of an investigational Port Delivery System with ranibizumab (Genentech) in patients with neovascular, or wet, age-related macular degeneration (AMD) have been reported.
The small and refillable eye implant allowed the majority of patients in all 3 tested treatment dosing groups to go 6 months or longer without needing to visit with their ophthalmologist to have their implant refilled—a welcome change from the burden of monthly injections of anti-vascular endothelial growth factor (anti-VEGF).
The trial randomized 179 patients to receive an implantation of the Port Delivery System with a dose of either 10 mg/mL (n = 58), 40 mg/mL (n = 62), or 100 mg/mL (n = 59) of ranibizumab. Of those receiving the 100 mg/mL dose, roughly 80% were able to go ≥6 months without needing their first refill of medication. In the 10 mg/mL and 40 mg/mL groups, 63.5% and 71.3% were able to go 6 months or more, respectively.
Although the ability to go longer without requiring injections is important, lead author Carl C. Awh, MD, told MD Magazine® that it’s important to remember that is just a single piece of the puzzle.
“It goes hand-in-hand with the outcomes. We reduce treatment burden now in the real world by injecting less than monthly,” Awh said. “But, what happens when you do that is you don’t achieve the same outcomes we did in the pivotal studies. Are patients still better than with no treatment? [They’re] much better. But, what we found in this study is we are getting comparable outcomes to monthly injections with something that addresses the treatment burden.”
“That’s the key—outcomes and treatment burden, not just reducing treatment burden,” he added.
As Awh mentioned, the trial also assessed the outcomes, for vision and anatomic measures, when compared to standard intravitreal ranibizumab 0.5-mg injections. Those who received the 100 mg/mL dose reported similar gains in Best-Corrected Visual Acuity (BCVA), as well as comparable reductions in measurements of central retina thickness. These specific data will be presented at future meetings as the analysis continues to be conducted, Awh said.
Findings the most appropriate dosing regimen and the proper timeline for refills are what the planned phase 3 clinical trial hopes to determine. “In the real world, you probably don’t want to wait until someone needs [a refill]. It’s probably better to give it before,” Awh said. That trial, he added, is set to begin enrolling later this year.
Sandra Horning, MD, the chief medical officer and head of Global Product Development at Genentech, noted in a statement that “LADDER is the first successful Phase II study of a long-acting delivery device for the treatment of wet AMD.” Investigator Carl D. Regillo, MD, the chief of Retina Service at Wills Eye Hospital in Philadelphia, noted that if the Port Delivery System is successful “it could have a major impact on the way we treat people with wet AMD. I believe that more consistent treatment could allow for better long-term vision outcomes in clinical practice.”
The Port Delivery System is implanted in a surgical procedure but is able to be refilled through a minimally invasive in-office procedure using a customized needle.
“It’s just very exciting to see these powerful outcomes and to think that we will have a way to make a fundamental change in the experience for our patients that maintains what, really, has been a miraculous thing we’ve been able to do with anti-VEGF treatment,” Awh said. “There’s still nothing immediately available that looks like it will be better. We know this is a class of drugs—and a particular drug, ranibizumab—that works, and to see that we can do that for patients and really address what’s been a nightmare of treatment burden for patients and doctors is tremendous.”
The study, “Study of the Efficacy and Safety of the Ranibizumab Port Delivery System (RPDS) for Sustained Delivery of Ranibizumab in Participants With Subfoveal Neovascular Age-Related Macular Degeneration (AMD),” was presented in a late-breaking session at the 36th ASRS annual meeting.
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