AMD year in review: Highlights from 2020
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Due to the COVID-19 pandemic, 2020 was marked by innovation and rapid advances in medicine, and the field of ophthalmology was no exception. With the unveiling of important data on age-related macular degeneration at the year’s major conferences, physicians may soon see these changes reflected in clinical practice.
To highlight these advances, Healio has compiled a list of exciting studies, along with expert commentary and reporting from this year’s virtual meetings, that showcase some of the novel therapies and new technologies in AMD.
Archway Trial
The phase 3 Archway trial, which was presented at the American Academy of Ophthalmology Meeting, evaluated the noninferiority and safety of continuous delivery of ranibizumab by a port delivery system (PDS) compared with monthly ranibizumab injections.
The study met all endpoints, with most patients preferring PDS to monthly treatments, according to Nancy M. Holekamp, MD, director of retina services at Pepose Vision Institute and professor of clinical ophthalmology at Washington University, who presented the findings.
In a video interview with Healio, Arshad M. Khanani, MD, MA, clinical associate professor of ophthalmology at the University of Nevada, placed the study results into clinical context, noting that PDS could offer a significant advantage for certain patients with AMD.
“Port delivery system with ranibizumab has the potential of decreasing treatment burden,” Khanani said. “The patient satisfaction survey that Dr. Holekamp presented showed over 90% of patients actually preferred the port delivery system, so these are exciting times for patients, as well as practicing physicians to have this option available, hopefully in the next few years.”
Caroline R. Baumal, MD, professor at Tufts University School of Medicine, also expressed excitement about the Archway findings.
“I look forward to seeing what happens over the next year with the port delivery system and whether it gets approved for treatment for our patients,” she told Healio.
KSI-301
Also at AAO, Khanani presented the positive 1-year-and-beyond data for KSI-301, an antibody biopolymer conjugate under investigation for use in wet AMD, diabetic macular edema and retinal vein occlusion, compared with aflibercept (Eylea, Regeneron).
“If we are able to have the similar efficacy and safety in the pivotal trials, it's going to help physicians, as well as patients, by decreasing the number of visits and number of injections that are required to maintain or improve vision in patients with wet AMD, DME and RVO. KSI-301 can address the top unmet need of having a durable agent with similar efficacy and safety as current agents to help patients decrease their visits to the clinic,” Khanani told Healio.
Commenting on the findings, Diana V. Do, from the Byers Eye Institute at Stanford University, expressed enthusiasm for safety and efficacy observed in the phase 3 study.
“Data showed that this individual agent was very safe, effective and could be dosed every 4 to 6 months and provide sustained anti-VEGF inhibition in wet AMD, DME and RVO. This is a very exciting biologic,” Do told Healio.
HAWK and HARRIER
Ophthalmology meetings throughout the year also saw discussion of multiple analyses of the phase 3 HAWK and HARRIER trials.
At the American Society of Retina Specialists Meeting, Carl D. Regillo, MD, FACS, chief of retina service at Wills Eye Hospital, presented data from a post hoc analysis of the studies evaluating brolucizumab (Beovu, Novartis) vs. aflibercept in patients with neovascular AMD over 96 weeks.
Additionally, at the AAO annual meeting, Jeffrey S. Heier, MD, co-president and medical director of Ophthalmic Consultants of Boston and assistant professor of ophthalmology at Tufts University School of Medicine, presented findings on patients with and without intraocular inflammation in the HAWK and HARRIER trials.
“Beovu has been out for the past year now, and we’re looking forward to utilizing this drug for patients ... where it could dry the retina better than other drugs that were currently available,” Rishi P. Singh, MD, staff surgeon at Cleveland Clinic Cole Eye Institute and associate professor of ophthalmology at Lerner College of Medicine, said in a video interview with Healio.
The problem, he said, has been intraocular inflammation. Heier presented “some of the more interesting characteristics of patients both with and without this inflammation,” which may help guide treatment decisions, according to Singh.
GATHER1
The phase 2/3 GATHER1 trial, designed to assess the efficacy of two different doses of the complement C5 inhibitor avacincaptad pegol (Zimura, Iveric bio) compared with sham control, was presented by Donald J. D’Amico, MD, at the AAO annual meeting.
The data were largely positive, linking the avacincaptad pegol to a reduction in AMD-related geographic atrophy.
“The GATHER1 study achieved the primary efficacy endpoint for reduction in the growth rate of geographic atrophy for both the 2 mg and 4 mg doses of avacincaptad vs. sham,” D’Amico, professor and chairman of ophthalmology at Weill Cornell Medical College and ophthalmologist-in-chief at the New York-Presbyterian Hospital, said during his presentation of the data.
In a video interview, Singh said that ophthalmologists are aware that “the alternative complement pathway plays a large role in the progression of patients with non-neovascular AMD or geographic atrophy,” adding that phase 2 and 3 studies have shown that they have been “beneficial to slow the progression and growth rate.”
OpRegen
Interim results of phase 1/2 clinical trial evaluating OpRegen (Lineage Cell Therapeutics) — subretinal transplantation of retinal pigment epithelial cells derived from human embryonic stem cells — were discussed at the Association for Research in Vision and Ophthalmology and AAO meetings.
Christopher D. Riemann, MD, vitreo-retinal fellowship director at the Cincinnati Eye Institute and associate professor at the University of Cincinnati School of Medicine, who presented the data at both conferences, said patients with dry AMD appeared to tolerate the treatment well and had stable or improved vision with OpRegen.
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