Sara Hojjatie, MD
University of Washington
Seattle, WA
The Wet AMD Session 2 at the ASRS Annual Meeting in Seattle, WA highlighted several novel methods of VEGF inhibition for neovascular age-related macular degeneration.
Dr. Ashkan Abbey of Texas Retina Associates discussed a Phase 2 pharmacodynamics study looking at the subretinal delivery of RGX-314 for neovascular AMD. Dr. Abbey reviewed a new suspension bioreactor process that produces the RGX-314 subretinal injection material in a scalable and automated fashion. The trial was nonrandomized and performed in patients who have been shown to have a response to anti-VEGF.
RGX-314 can be administered subretinally during vitrectomy or in the office with a suprachoroidal injection. Participants received a vitrectomy with subretinal injection of RGX-314, then received a bolus injection of ranibizumab two weeks later. Patients were followed for six months after the procedure. No prophylactic steroids were given beyond the standard of care drops. One study group was given a high dose of RGX-314 and one group a lower dose. The primary end point was protein levels of RGX-314 in the anterior chamber. Secondary endpoints included visual acuity and anatomical outcomes, safety, and the need for re-treatment.
The results showed that visual acuity and central retinal thickness was stable or improved over the six months of the study. In the high-dose group, most patients required no supplemental injections over the six month period based on the study’s retreatment criteria. These patients previously received an average of 8-9 injections per year. This is exciting as it represents a potential reduction in treatment burden.
Overall, the medication was well tolerated, and no serious adverse events were considered drug-related. Postoperative subconjunctival hemorrhage and inflammation were the most commonly reported adverse events. These were considered mild-moderate and resolved within days to weeks with topical drops. Dr. Abbey recommends this therapeutic option for patients who do not tolerate in-office injections well.
Other talks during this session included those looking at other delivery systems for anti-VEGF, ranibizumab biosimilars, and home OCT systems.
Dr. Philip Storey of Austin Retina presented on the Phase 1 DAVIO Trial of EYP-1901, looking at the safety and efficacy of Vorolanib as maintenance therapy in patients with previously treated wet AMD. Vorolanib is a pan-VEGF receptor inhibitor delivered in the Durasert® intravitreal insert. Over the course of the study, no intraocular inflammation was observed, and visual acuity and CST remained stable. We look forward to the results of DAVIO 2 later this year.
Dr. David Massop of the Wolfe Eye Clinic presented on five-year results of the port delivery system with ranibizumab (PDS, Susvimo) for neovascular AMD, evaluating long-term efficacy and safety. Adverse ocular events included hyphema and cataracts with zero study patients developing endophthalmitis. Over the 5-year period, visual acuity was stable.
Dr. Carl Awh of Tennessee Retina then presented on Ranibizumab-nuna (Byooviz) and Ranibizumab-eqrn (Cimerli), which are ranibizumab biosimilars, in clinical use. He presented data from patients across 16 practices within the United States who were followed for at least 28 days after their first injection with a ranibizumab biosimilar. No change in VA after injection, no cases of vasculitis, and no inflammatory responses to the drug were observed. There were three cases of presumed bacterial endophthalmitis. The sample size was too small to make large outcome predictions.
Dr. Rahul Khurana of Northern California Retina Vitreous Associates talked about a CLS-AX suprachoroidal injection of axitinib, a tyrosine kinase inhibitor. The study presented found no inflammatory events, including no vasculitis. The average number of injections also decreased, reducing the patient’s treatment burden. Vision and central subfield thickness was maintained throughout the treatment period.
Finally, Dr. Kevin Blinder of the Retina Institute of St. Louis presented on Home OCT Monitoring Systems: Protocol AK. The objectives of the trial were to assess the feasibility, to collect data, and to validate the ability of the Home OCT to detect exudation. This study included patients who were newly diagnosed with untreated nAMD. Fourteen patients were enrolled in the study. Participants scanned themselves daily for six months and were concurrently followed and treated for nAMD based on in-office OCTs. The home OCT scans were compared to the in-office OCT scans.
Bevacizumab was the most common medication injected during the follow-up period. The participants performed an average of six scans per week, each scan taking less than one minute per eye. The average number of scans was able to be sustained throughout the study period. Participants found the device to be easy to use and comfortable. The study found good compliance on scanning and scan qualities. The home OCT machines demonstrated good agreement with the in-office scans. The hope is that home OCT images can be used by providers to help monitor disease.
Overall, the session resulted in an engaging discussion about the future of anti-VEGF therapies and patient treatment options.
