An approval may be pending for the unique delivery system. An expert explains its benefit for nAMD patients and physicians alike.
In the coming weeks, the US Food and Drug Administration (FDA) will be considering the application for ranibizumab delivered via port delivery system (PDS) for the treatment of patients with neovascular age-related macular degeneration (nAMD).
The timing for a potential approve aligns perfectly with expert discussion being hosted at a pair of national ophthalmology meetings this month, the first being the American Society of Retina Specialists (ASRS) 2021 Scientific Meeting this week. In fact, new data from the phase 3 Archway trial presented at ASRS showed the uniquely-delivered anti-VEGF therapy is not impacted by patient retinal fluid rates.
In an interview with HCPLive during ASRS 2021, presenting author Arshad M. Khanani, MD, MA, managing partner of Sierra Eye Associates, discussed what a fully-approved ranbizumab PDS agent could mean for patients with nAMD.
“Essentially, this is designed for sustained delivery of ranibizumab, so we can decrease the treatment burden for our patients with neovascular AMD,” Khanani said.
Khanani also explained the perceptible differences between clinical trial data—in which patients are consistently administered anti-VEGF injections to sustain vision improvements—and real-world outcomes—in which patients are more prone to miss monthly injections and compromise their disease management.
The difference that can be made with an agent approved for PDS delivery, he explained, is patient buy-in to assured long-term care without need for frequent intravitreal injections.
The benefit for physicians is apparent for those who are already familiar, as well.
“I think for physicians who are in the clinical trials, and have been trained to do the surgery in the operating room and the refill exchange procedure in clinic, they are very comfortable with the profile of efficacy and safety,” Khanani said.