Developments in imaging, translational research and clinical trials of treatments for retinal diseases dominated discussion at the two-day Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2022 virtual conference.
The two-day Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2022 virtual conference provided updates for clinicians and researchers on developments in imaging, translational research and clinical trials of treatments for retinal diseases. The Ophthalmology Times® Viewpoint series gathered several speakers to discuss their presentations.
Dr David Eichenbaum, director of research, Retina Vitreous Associates of Florida and collaborative associate professor of Ophthalmology, Morsani College of Medicine at the University of South Florida, St. Petersburg, and Dr Peter Campochiaro, George S. and Dolores Dore Eccles professor of ophthalmology and Neuroscience, Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland, discussed the Port Delivery System (PDS) with ranibizumab (Suvismo, Genentech) for treatment of neovascular age-related macular degeneration (nAMD).
Dr Eichenbaum reviewed his presentation on long-term outcomes based on data from patients followed for up to 4 years. He reported that overall, patients maintained their baseline vision, and thus efficacy was demonstrated.
Drilling down to look at individual data showed some heterogeneity in how well patients maintain disease control; about 90% of patients had excellent control of exudation and the remaining 10% had moderate or severe exudation sometime after PDS implantation. Recurrent exudation was most often subretinal fluid.
The rate of supplemental injections was low and the supplemental injections were most often given for a decrease in vision, which often occurred without exudation. Dr Campochiaro suggested the supplemental injection rate will be even lower in clinical practice, recognising that a drop in vision without exudation may be due to dry eye or a cause other than nAMD.
“One of the things that the port delivery system taught us is that sustained suppression of VEGF is really the correct way to treat this disease,” said Dr Campochiaro. Regarding safety, most adverse events of special interest occurred in the first 2 years. However, there are problems clinicians must continue to watch for, and those mostly involve the conjunctiva (erosion and retraction) and ocular surface.
Erosion is manageable but is important to watch for because it can lead to endophthalmitis, Dr Eichenbaum explained. Surgical and patient-related factors that can be associated with problems post-implantation were discussed, and it was noted that time will tell if a change in surgical technique implemented during the clinical trial program translates into a reduced rate of late erosions.
Additional data showed that patients strongly preferred PDS treatment over conventional injections. “I think this translation to patient happiness…is going to be a big impetus to offer this in clinical practice once surgeons in the community get experience with the PDS,” Dr Eichenbaum said.
Dr Jennifer K. Sun and Dr Jonathan F. Russell discussed the need for a new staging system for diabetic retinal disease. They spoke about the limitations of the Early Treatment Diabetic Retinopathy Study Severity Scale and the advancements that have occurred since its introduction that support the need for an updated staging system.
“The consensus of many of us in the field has been that our current staging system does not incorporate all the new insights that we have and all the imaging modalities that we can bring to bear on the retina,” said Dr Sun, associate professor of ophthalmology, Harvard Medical School, Boston, Massachusetts.
She said that a new system for rating the severity of diabetic retinal disease should be multidimensional and a more holistic scale that incorporates retinal, neural and vascular pathology and their contributions to visual function within a background of the molecular disease mechanisms and systemic health.
Dr Sun noted that an effort to create an updated diabetic retinal disease staging system is supported by the Juvenile Diabetes Research Foundation and The Mary Tyler Moore and S. Robert Levine, MD Charitable Foundation. She reviewed the work in progress and noted the update is the first step in the Restoring Vision Moonshot Initiative.
Dr Russell, assistant professor of vitreoretinal disease and surgery, University of Iowa, Iowa City, reviewed the advantages of using wide field swept-source optical coherence tomography angiography for evaluating patients with diabetic retinopathy and provided an overview of a proposed staging system that is based on this technology.
Drs Russell and Sun addressed the possibility that new staging systems will lead to the introduction of new terminology for describing diabetic retinopathy. They noted it might even result in a move away from using the latter term, which does not encompass the neural and other changes associated with diabetic retinal disease.
The latest findings from Phase 3 clinical trials investigating faricimab (Vabysmo, Genentech) for the treatment of nAMD and diabetic macular oedema (DMO) were discussed by Dr Robyn Guymer and Dr John A. Wells, chairman, Department of Ophthalmology, Palmetto Retina Center, Columbia, South Carolina. Dr Wells reviewed topline results from 48 weeks of follow-up in the TENAYA and LUCERNE nAMD studies that showed BCVA gains from baseline in patients being treated with faricimab 6 mg up to every 16 weeks were non-inferior to controls receiving aflibercept (Eylea, Regeneron) 2 mg every 8 weeks.
The durability of faricimab’s effect was highlighted by data showing that around 45% of patients were receiving injections every 16 weeks and almost 80% were being treated every 12 or every 16 weeks. Faricimab-treated patients also had greater reductions in central subfield thickness than the aflibercept groups.
Dr Guymer, professor of ophthalmology, University of Melbourne, East Melbourne, Australia, discussed data from 2 years of follow-up in the YOSEMITE and RHINE studies of faricimab treatment for DMO that also showed that faricimab administered according to a personalised treatment interval regimen greatly reduced injection burden and was associated with stable vision gains that were non-inferior to aflibercept 2 mg every 8 weeks or more regular faricimab injections.
She reported that at 2 years, around 60% of patients in the personalised treatment interval arm were being treated every 16 weeks and another 18% were receiving injections every 12 weeks. Vision gains achieved at 1 year were maintained at 2 years and reduction in central subfield thickness was better than with aflibercept.
Discussing safety, both Dr Guymer and Dr Wells highlighted the absence of cases of vasculitis or occlusive retinitis in the faricimab groups, which is important considering the occurrence of vasculitis with other new drugs, Dr Guymer said.
Produced in partnership with Roche.