Graybug Vision, a clinical stage pharmaceutical company developing potentially transformative long-acting therapies for ocular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and primary open angle glaucoma (POAG), today announced the securing of an $80 million Series C financing.

Proceeds from the financing will be used to progress GB-102, the company's lead asset, into both a phase 2b clinical study (the ALTISSIMO study) in wet AMD as well as a Phase 2a study in macular edema secondary to DME or RVO. The funding will also be used to advance GB-401, the company's preclinical glaucoma asset, into the clinic in 2020.

The Series C financing was led by CBC Group (formerly known as C-Bridge Capital), a new investor, and includes participation from existing investors Deerfield Management, OrbiMed Advisors, Hatteras Venture Partners, a fund managed by Blackstone Life Sciences, and other new investors.

Michael Keyoung, MD, PhD, Managing Director and Head of North America at CBC Group, and Chairman of AffaMed Therapeutics, will be joining the Board of Directors of Graybug Vision with immediate effect. "We have great confidence in Graybug Vision's management team and are excited by the potential of the company's lead asset, GB-102, to reduce the treatment burden in patients suffering from retinal diseases," said Michael Keyoung. "We look forward to working with Graybug Vision as they develop GB-102 and continue to advance their pipeline." Justin Hanes, PhD, a company founder and Lewis J. Ort Professor of Ophthalmology at the Wilmer Eye Institute, will transition to Board observer and continue to actively support the company.

Graybug Vision's transformative retina and glaucoma clinical programs

GB-102, a pan-VEGF inhibitor, is a potential twice-per-year treatment targeted to alleviate the significant burden of current therapies, and reduce the need for frequent intravitreal injections of currently approved anti-VEGF treatments of wet AMD, DME and RVO. GB-102 completed a Phase 1/2a study (ADAGIO study) in Q1 2019 in which GB-102 met the primary endpoint of safety and tolerability and provided evidence of a durable biological signal. Graybug Vision plans to commence enrollment of the ALTISSIMO study in Q3 2019, a one-year, 220-patient Phase 2b study of GB-102 targeted to achieve dosing every six months in wet AMD. The company also plans to commence enrollment of a six-month Phase 2a study of GB-102 in macular edema secondary to DME and RVO in Q3 2019.

GB-401, an intravitreal injection of the company's proprietary new molecular entity, is designed to be administered every four to six months in patients with primary open angle glaucoma (POAG). While eye drops, the current standard of treatment for POAG, are effective at reducing intraocular pressure, patients often struggle to administer them once or several times a day, which may lead to vision impairment or loss. GB-401 is anticipated to improve compliance and clinical outcomes with sustained intraocular pressure reductions. Graybug Vision plans to commence enrollment in a Phase 2a study in 2020.

"We are grateful for the strong support from our new and existing investors who share our long-term vision for our company and appreciate the need for long-acting, safe, and effective ocular therapies," said Frederic Guerard, President and CEO of Graybug Vision. "The need for transforming patient outcomes in clinical practice has never been higher, and we look forward to announcing the initiation of enrollment in two GB-102 phase 2 studies later this year, as well as providing updates on our glaucoma program as it progresses towards a first-in-human study in 2020."

About Wet Age-related Macular Degeneration (wet AMD)

Wet AMD is the leading cause of blindness in the developed world in individuals aged 50 years or older. It is caused by the formation of abnormal and leaky new blood vessels behind the retina, termed choroidal neovascularization. The leakage of fluid and protein from the vessels, causes retinal degeneration and leads to severe and rapid loss of vision. According to the National Eye Institute, the prevalence of wet AMD among adults 40 years or older in the United States alone is estimated at 1.75 million people. In addition, an estimated 20 million adults are affected by wet AMD worldwide.

About Diabetic Macular Edema (DME)

DME is caused by a complication of diabetes called diabetic retinopathy (DR) and is a leading cause of irreversible blindness in working age individuals 50 years and younger. Diabetes can lead to abnormal retinal blood vessels that can leak fluid causing swelling of the retina (DME) and subsequent vision loss. Of an estimated 285 million people with diabetes worldwide, approximately a third is associated with vision-threatening DME. These estimates are expected to rise further due to the increasing prevalence of diabetes, ageing of the population and increasing life expectancy of those with diabetes.

About Retinal Vein Occlusion (RVO)

RVO is a condition in which the main vein or its branches that drains blood from the retina closes off partially or completely. Blockage of the blood vessels can lead to swelling of the retina (macular edema) leading to vision-loss. The incidence of RVOs is estimated at 180,000 eyes per year in the United States and branched blockages account for nearly 80%. An estimated 16 million adults are affected by RVO worldwide.

About Primary Open Angle Glaucoma (POAG)

POAG is a leading cause of blindness worldwide and is a condition in which the clear fluid (called aqueous humor) inside the eye behind the cornea cannot drain properly causing the fluid to build up and elevating intraocular pressure (IOP) in the eye that can permanently damage the optic nerve. The only proven treatment to slow or halt progression of vision-loss in glaucoma is to reduce IOP, commonly with patient-administered eye drops. The estimated number of individuals with POAG is approximately 3 million in the US alone and over 30 million worldwide.

About Graybug Vision

Graybug Vision is a clinical stage pharmaceutical company developing novel products for the treatment of ocular diseases. The company's proprietary injectable products are designed to enable less frequent administration to reduce the burden of treatment for patients and their physicians. The company's lead clinical-stage injectable product, GB-102, has the potential to achieve 6-month dosing in the treatment of retinal diseases. GB-401 has the potential to achieve 4 to 6-month dosing in the treatment of elevated IOP associated with POAG. For more information, please visit www.graybug.com.