Retina Subspecialty Day at the American Academy of Ophthalmology 2017
June 6, 2017
San Diego County Optometric Society Newsletter: Retina Corner
By Nikolas J.S. London, MD FACS
President and Director of Clinical Research, Retina Consultants San Diego
Chief of Ophthalmology, Scripps Memorial Hospital La Jolla
Dear SDCOS membership,
Every year, thousands of retina specialists from across the globe gather at the Retina Subspecialty Day Meeting prior to the annual meeting of the American Academy of Ophthalmology. This year was in beautiful New Orleans, Louisiana, and we were treated to several excellent clinical trial presentations, interactive point-counterpoint debates, surgical video discussions, and demonstration of cutting-edge technology and surgical techniques. Below is a brief summary of a few of these presentations.
Lampalizumab
Presented by Dr. Jeffrey Heier
Genentech’s Chroma and Spectri studies evaluated the safety and efficacy of lampalizumab, an anti-complement factor D monoclonal antibody fragment, for the treatment of geographic atrophy. The phase II MAHALO study suggested a 20% reduction in the growth of atrophy in treated patients, and an impressive 44% reduction in patients positive for the complement factor I biomarker. In fact, the growth rate reduction appeared to be driven entirely by cohort of patients positive for complement factor I (CFI+). the. However, this was a small study of 129 patients.
The follow-up phase III studies were presented by Jeffrey Heier at the meeting. They enrolled over 1,800 patients to 2 study arms: q 4 week sham, q 4 week lampalizumab 10mg, q 6 week sham, or q 6 week lampalizumab 10mg. CFI+ patients were targeted during enrollment. The primary outcome was the mean change in area of atrophy measured by fundus autofluorescence at 48 weeks. Unfortunately, this was not met in either study, not for the cohorts as a whole or for the CFI+ subgroups.
It is always disappointing when clinical trial results end up negative, particularly for disease states where we currently have no therapeutic options for our patients. Fortunately, however, several other therapeutic options are still under investigation including a higher upstream complement inhibitor from Apellis Pharmaceuticals as well as a stem cell study from Astellas Institute for Regenerative Medicine. RCSD will hopefully be involved in both of these trials.
HAWK and HARRIER: Brolucizumab
Presented by Dr. Pravin Dugel
Switching gears, Dr. Pravin Dugel gave what was certainly one of the most buzz-worthy presentations of the meeting on the outcomes of the phase III HAWK and HARRIER trials.
These studies examined the efficacy of the novel single-chain variable fragment, a 26kKa antiVEGF molecule, in neovascular age-related macular degeneration (AMD). They enrolled over 1,800 patients with treatment-naïve neovascular AMD in 48-week, multi-centered, randomized, double-masked trials comparing brolucizumab to aflibercept (Eylea). Upon enrollment, all patients were treated with three monthly injections of their assigned medication. Following this, eyes in the brolucizumab arm were treated every 12 weeks with an option to reduce this to every 8 weeks based on disease activity. Eyes in the aflibercept arm were dosed every 8 weeks following the loading phase.
Overall, brolucizumab met the goal of non-inferiority compared to aflibercept. Moreover, more than half of the eyes in the brolucizumab arm were maintained on every 12-week injections, and at both 4 and 11 months compared to aflibercept, roughly a third fewer brolucizumab-treated patients had persistent intraretinal fluid on OCT (p<0.0001). There were no new adverse event signals. These studies will continue on through week 96, and are expected to conclude in the middle of 2018.
Thanks again for reading. Please don’t hesitate to contact me with any questions.
Best wishes, and until next time,
