The first approval for the novel device was met with acclaim in the field this year. Now, specialists want to see how their colleagues will implement it.
New innovations move the field of medicine forward, providing novel avenues for treatment and aiding both clinician and patient in the management of diseases—particularly chronic diseases that require an increased amount of care.
Especially in the field of ophthalmology, such advances are reshaping the actual practice of eye care, from new agents to new efforts made to reduce the treatment burden of both the patient and the clinicians.
Of course, probably the biggest advancement this year in ophthalmology was the port delivery system (PDS) with ranibizumab (Susvimo), recently approved by the US Food and Drug Administration (FDA) for the treatment of neovascular (wet) age-related macular degeneration (nAMD).
Most nAMD patients are treated with frequent intravitreal injection therapy. Thus, the device itself represents more permanence in care, as a novel permanent eye implant that provides a continuous administration of ranibizumab formulation through a vitreous cavity.
As clinicians have previously explained to HCPLive, an important factor to note is that less injections generally means less treatment burden put onto a patient.
“Port delivery system is, thankfully, recently FDA approved and something that can really extend the life of a drug in the patient's eye, which then by definition, allows us to back off those injections and improves that patient's quality of life,” said Veeral Sheth, MD, Director of Clinical Trials, University Retina.
The FDA approval was based on the phase 3 ARCHWAY trial, a randomized, multicenter, open-label trial designed to assess the efficacy and safety of PDS with ranibizumab, compared to intravitreal ranibizumab injection in patients with nAMD.
A total of 418 patients were randomized to PDS implant with 6-month refills of ranibizumab, or monthly intravitreal injection of 0.5 mg ranibizumab. The primary endpoint was considered the best corrected visual acuity (BCVA) from baseline weeks 36 and 40, with secondary endpoints including safety, overall change in BCVA and center retina thickness.
These patients were previously responsive to anti-VEGF therapy, with ≥3 anti-VEGF injections within 6 months prior to trial screening.
Data from the trial show noninferiority of ranibizumab PDS to monthly ranibizumab injections. Those undergoing port delivery care improved BCVA by a mean 0.2 letters from baseline, in comparison to 0.5 letters in patients given injections. Additionally, consistent central retina thickness was observed across PDS and injection patients, with a 10 mcm change at week 36.
ARCHWAY data also showed 1.6% of patients with a PDS implant needed supplemental treatment for nAMD at first treatment interval. An overall favorable benefit-risk profile was observed with PDS with ranibizumab.
“The port delivery system represents another big, big step forward in how we manage nAMD, because it's true sustained delivery,” said Carl D. Regillo, MD, Director of Retina Service, Wills Eye Hospital, the principal investigator on the ARCHWAY study.
Arshad Khanani, MD, Managing Partner, Sierra Eye Associates, added in an interview with HCPLive that the data remains positive in regards to fluid’s effect on the efficacy of PDS in this patient population. He had previously presented the data at the American Society of Retina Specialists (ASRS) 2021 Meeting.
“I actually presented the data at ASRS about fluid in patients with the port delivery system and what we actually saw was that the majority of the patients had no fluid, and they were well controlled,” Khanani said.
The approval of PDS with ranibizumab represents 3 crucial factors in eye care: efficacy, safety, and durability.
Some have labeled its approval as a leap forward in the management of nAMD from the perspective of the clinician. An increased level of sustainability leads to less patient visits for injections and thus, a less overwhelming slate of patients for the caregiver.
“I think the port delivery system is a very exciting technology and certainly it speaks to also trying to reduce burden by increasing durability,” said Dilsher Dhoot, MD, California Retina Consultants. “It will be great to see what the uptake will be.”
Others have discussed keeping in mind the patient’s own burden, and how that may have increased both stress and fatigue associated with constant doctors office visits and frequent injections. David Lally, MD, Assistant Professor of Surgery, University of Massachusetts Medical School - Baystate, opined that PDS with ranibizumab is a great option for patients for these very reasons.
“In terms of those patients who are looking to reduce their treatment burden, many of our patients get very fatigued coming in month after month, year after year receiving injections into their eye,” he said.
Another facet of patient burden is the impact the COVID-19 pandemic has had on all of medicine, sprawling from the ICU to patients with AMD. It wasn’t necessarily the disease, but the restrictions that deterred these patients, who are generally already older and may have more trouble getting to an appointment.
This point was hammered in by Julia A Haller, MD, Ophthalmologist-in-Chief, Wills Eye Hospital, explaining that while PDS is viable in order for patients to live a more normal life, it also benefits them strategically at this time, during the COVID-19 pandemic.
“Particularly for people who are requiring very frequent injections in their eye, many of whom have to depend on family and caregivers to bring them into the hospital, particularly in times like these where you worry about getting sick and all the pandemic restrictions,” Haller said. “I think the time was right for this delivery system to come out and we're all very excited about it offering another option”
Others touched on how this decision impacted the burden that clinicians, not patients, face when dealing with an increased population who are suffering from the buildup of the chronic blinding disease.
“Also, the retinal physicians, we have a fixed amount of bandwidth to address vision threatening disease, and as the population ages, and we see more age-related eye disease, we're going to reach some sort of saturation level where we can't, you know, take care of any more patients,” said Theodore Leng, MD, Department of Ophthalmology, Stanford University.
Currently, PDS is only approved for use with ranibizumab, but other indications may be forthcoming. “I think having a sustained delivery device, like the port delivery system, is really going to help kind of unload our schedules a little bit so we can care for other indications, and also new therapies that are coming to market,” Leng said.
Seemingly, there are a lack of downsides to the approval and what it might mean for the future of ophthalmology care. While no clinician pointed out errors in treatment, due to positive data, it is apparent that there are still questions on how the novel procedure will become associated—either positively or negatively—with physician familiarity and patient upkeep.
“I think both physicians and patients are going to be very excited to have the opportunity to have this new tool in our tool belt that may be able to significantly reduce the treatment burden for those patients,” Lally said.
For now, the lasting potential of the approval and what it ultimately means in ophthalmology care feels like a greater waiting game than the approval itself—but one that is expected to be a resounding success.
“This is an even bigger step towards decreased treatment burden and the prospect of getting better vision outcomes, knowing that real world experience, so the port delivery is going to be a great option for many of our patients,” Regillo said.