REDWOOD CITY, Calif., April 21, 2020 – Graybug Vision, Inc., a clinical stage biopharmaceutical company focused on developing transformative medicines to treat vision-threatening diseases of the retina and optic nerve, announces that a recent publication of the article ‘Sustained treatment of retinal vascular diseases with self-aggregating sunitinib microparticles’ in Nature Communications was recognized as an Editors’ Highlight by the publication. 

The article details the findings of a collaborative preclinical research project involving scientists at Graybug Vision and the Johns Hopkins University School of Medicine. The researchers developed a novel non-inflammatory polymer microparticle formulation containing sunitinib, an approved tyrosine kinase inhibitor drug that blocks vascular endothelial growth factor (VEGF) receptors. The microparticle formulation was specifically designed to self-aggregate into a depot in the eye.

The study demonstrated that a single intravitreal (IVT) injection of sunitinib microparticles potently suppresses choroidal neovascularization in a mouse model for six months, far longer than the effect of an IVT injection of aflibercept in the same model. The sunitinib microparticles were also shown to block VEGF-induced leukostasis and retinal nonperfusion, which are associated with the progression of diabetic retinopathy.

The invention of new compositions and methods to produce non-inflammatory polymer microparticles for the eye was a key achievement in prior research led by Justin Hanes, Ph.D., Lewis J. Ort Professor of Ophthalmology and Director of the Center of Nanomedicine at the Johns Hopkins University School of Medicine, and Peter J. McDonnell, Director of the Wilmer Eye Institute at Johns Hopkins. Graybug Vision was founded on the basis of technologies initially developed by Justin Hanes in collaboration with co-author Peter A. Campochiaro, M.D., Professor of Ophthalmology and Director of the Retinal Cell and Molecular Laboratory at Johns Hopkins School of Medicine.

“VEGF signaling plays a critical role in retinal diseases like wet age-related macular degeneration, and our experiments with the sunitinib sustained-release formulation showed efficacy and durability,” said Ming Yang, Vice President of Research and Development at Graybug Vision. “Based on the results reported in this publication, Graybug advanced GB-102 into clinical development to evaluate its potential to improve the lives of patients with ocular diseases,” concluded Ming Yang.

GB-102, Graybug’s microparticle depot formulation of the anti-VEGF sunitinib malate, is currently in Phase 2 clinical development in patients with wet age-related macular degeneration (wet AMD). It seeks to reduce the need for frequent IVT injections by expanding treatment duration to six months while reducing the burden of current treatments.

About Wet AMD
Wet AMD is one of the most common retinal diseases, leading to vision decline caused by excess VEGF. VEGF is a protein produced by cells that stimulates the formation of abnormal new blood vessels behind the retina, called choroidal neovascularization. The leakage of fluid and protein from the vessels causes retinal degeneration and leads to severe and rapid loss of vision. Early intervention is essential to treat wet AMD. According to the American Academy of Ophthalmology, the prevalence of wet AMD in the United States is estimated at 1.75 million people. We estimate that approximately 20 million adults are affected by wet AMD worldwide.

About Graybug Vision
Graybug Vision is a clinical stage biopharmaceutical company focused on developing transformative medicines to treat diseases of the retina and optic nerve. The company’s proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for up to six months and potentially longer, improving patient compliance, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug’s lead product candidate, GB-102, a microparticle depot formulation of sunitinib malate, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration, with a six-month dosing regimen. This approach is differentiated from the current standard of care, which requires more frequent dosing and primarily targets one neovascular pathway. Graybug is also using its proprietary technologies to develop GB-401, an injectable depot formulation of a beta-adrenergic prodrug, for primary open angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.com.

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