REDWOOD CITY, CA--(Marketwired - May 2, 2016) - Graybug Vision, Inc., a venture-stage pharmaceutical company committed to developing potentially transformative therapies for ocular diseases including wet age-related macular degeneration (AMD) and glaucoma, today announced that data from a preclinical study of its lead product, GB-102, a novel injectable depot formulation containing a compound blocking VEGF and PDGF receptors for twice a year treatment of wet AMD, was presented in a poster session today at the Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting in Seattle, WA.
Raquel Formica, PhD, a senior investigator in the Retinal Cell and Molecular Laboratory directed by Peter A. Campochiaro, MD, at the Wilmer Eye Institute of Johns Hopkins University, in collaboration with Justin Hanes, PhD, the Lewis J. Ort Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University, a renowned bioengineer with extensive expertise in polymer chemistry and drug delivery, presented data demonstrating prolonged suppression of choroidal neovascularization (CNV) after a single intravitreous injection of GB-102 in a poster entitled, "Sustained Suppression of Murine Choroidal Neovascularization by Intravitreous Injection of Sunitinib-encapsulated Polymer Microparticles."
The objective of the study was to evaluate the long-term efficacy of sunitinib released from biodegradable polymer microparticles following intravitreous injection in a mouse model of laser-induced CNV, which has shown predictive value for effects of agents such as Eylea® in clinical trials. The results showed inhibition of CNV at all time points after injection through 9 weeks, the longest time point tested. These data suggest that sunitinib microparticles may provide a durable new treatment for neovascular AMD.
"We appreciate the excellent work done by Drs. Hanes, Campochiaro and their team. Their data validates the efficacy of our lead product, GB-102, in a standard model of neovascular AMD, a mouse laser model," said Jeffrey L. Cleland, PhD, President and Chief Executive Officer, Graybug Vision, Inc.
Study Design and Results
In the study reported for the first time at ARVO, researchers from the laboratory of Dr. Hanes incorporated sunitinib, an FDA-approved potent receptor tyrosine kinase inhibitor that blocks all members of the VEGF and PDGF receptor families, into biodegradable polymer microparticles. Microparticles were characterized in vitro, including average size, size distribution, drug loading and drug release profile. The microparticles had drug loading of 3.4% (by weight) and a mean diameter of about 13 µm.
In Dr. Campochiaro's laboratory, cohorts of C57BL/6 mice (n=5) had intravitreous injection of sunitinib microparticles (10 µg total drug content) and laser-induced rupture of Bruch's membrane at 0, 2, 4, or 8 weeks after injection. The area of CNV was measured one week after laser treatment (1, 3, 5, and 9 weeks after microparticle injection). A statistically significant reduction in the area of CNV was observed at each time point through 9 weeks in microparticle-injected eyes compared with corresponding controls. The mean area of CNV (mm2 x 10-3) in microparticle-injected eyes versus controls was: 1 week, 5.0±0.9 vs 8.0±1.0; 3 weeks, 10.6±1.2 vs 15.3±1.5; 5 weeks, 8.6±1.5 vs 14.5±1.7; and 9 weeks, 9.7±3.7 vs 22.5±5.4.
About Graybug Vision
Graybug Vision, Inc. is developing novel products for the treatment of ocular diseases. Graybug Vision's technologies enable the delivery of compounds to the eye up to twice per year and were co-developed by Graybug Vision founder Justin Hanes, PhD, who is the Lewis J. Ort Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University, in collaboration with Graybug Vision cofounders, and leading ophthalmology clinician-scientists from the Wilmer Eye Institute Peter A. Campochiaro, MD, and Peter J. McDonnell, MD. Graybug Vision's lead product, GB-102, is being developed for twice a year treatment of wet AMD patients. Graybug Vision's second product consists of compounds with intraocular pressure lowering and neuroprotection that may be administered to the subconjunctiva twice per year for the treatment of glaucoma. For more information, please visit www.graybug.com.
EYLEA® is a registered mark of Regeneron Pharmaceuticals, Inc.
Contact Information:
Graybug Vision, Inc. Corporate
Jeffrey L. Cleland, PhD
650-868-5853
or
Graybug Vision, Inc. Media
Debra Bannister
530-676-7373