1:07 What is the Port Delivery System?
2:39 The history of developing the PDS
17:00 Is PDS exclusive to anti-VEGF?
19:52 Thoughts on the ranbizumab PDS approval
23:10 How will guidelines change?
24:15 Tips for best PDS use
26:30 Closing thoughts
The US Food and Drug Administration (FDA) approved the Port Delivery System (PDS) with anti-VEGF therapy ranibizumab for the treatment of wet age-related macular degeneration (AMD) last month, a decision which introduced a novel ophthalmic treatment delivery product to the US and capped off a 2-decade research venture into PDS.
The historic approval granted to Roche could implicate long-term benefits in treatment adherence and efficacy—and therefore, retention of vision and quality of life—in the burdened retina disease patient population. The permanent eye implant is designed to provide patients a continuous administration of formulary anti-VEGF therapy—the gold standard for AMD treatment—through a vitreous cavity that does not require intravenous injections, nor refills for months at a time.
The late-October timing of the approval could not be more apt, as clinicians gathered to highlight and review PDS-relevant data at the American Society of Retina Specialists (ASRS) 2021 Meeting and American Academy of Ophthalmology (AAO) 2021 Meeting shortly prior to and after the FDA decision, respectively. Many ophthalmologists talked with HCPLive on the promising implication of PDS, as well as the anticipated early hurdles of application and monitoring in patients.
But one expert was able to speak fully to the long-term history and future potential of the novel product.
Carl Regillo, MD, Director of Retina Service at Wills Eye Hospital in Philadelphia, joined DocTalk to discuss ranibizumab PDS, his experiences with port delivery research that spans 15 years, what the application of the new anti-VEGF delivery method could mean for wet AMD, and where he thinks PDS may also serve ophthalmologists.