The new funding is in addition to a $4 million venture capital investment received by Clearside Biomedical in early 2012 that served as the foundation for the startup company.
Santen Pharmaceuticals Co., Ltd in Osaka, Japan, will fund Clearside’s technology development, and has also entered into a research collaboration agreement for posterior ocular diseases. Santen, along with new investor Mountain Group Capital and its affiliates, joins current investors Hatteras Venture Partners in Durham, NC, the Georgia Research Alliance Venture Fund, and the University of North Carolina’s Kenan Flagler Business School Private Equity Fund.
Clearside Biomedical is developing microinjection technology that uses hollow microneedles to precisely deliver drugs to a targeted area at the back of the eye. If the technique proves successful in clinical trials and wins regulatory approval, it could provide an improved method for treating diseases including age-related macular degeneration and glaucoma, as well as other ocular conditions related to diabetes.
The technology was developed in a collaboration between the research groups of Henry Edelhauser, PhD, professor of ophthalmology at Emory University School of Medicine, and Mark Prausnitz, PhD, a Regents’ professor in Georgia Tech’s School of Chemical and Biomolecular Engineering. The National Institutes of Health sponsored research leading to development of the technology.
In contrast to standard treatments, this microneedle technology provides a more targeted approach for treating retinal diseases that confines the drug to the site of disease and reduces side effects from exposing other parts of the eye. Prior to the development of this technology, drugs could be delivered to the retinal tissues at the back of the eye in three ways: injection by hypodermic needle into the eye’s vitreous humor (the gelatinous material that fills the eyeball); eye drops, which have limited ability to reach the back of the eye; and pills taken by mouth that expose the whole body to the drug.
The technology developed by Georgia Tech and Emory uses a hollow micron-scale needle to inject drugs into the suprachoroidal space located between the outer surface of the eye – known as the sclera – and the choroid, a deeper layer that provides nutrients to the rest of the eye. Preclinical research has shown that fluid can flow between the two layers, where it can spread out along the circumference of the eye, targeting structures like the choroid and retina that are now difficult to reach.
By targeting the suprachoroidal space using microscopic needles, the researchers believe they can reduce trauma to the eye, make drugs more effective and reduce complications. The new delivery method could help advance a new series of drugs being developed to target the retina, choroid and other structures in the back of the eye.
“I cannot imagine a better alliance as we continue to understand the role the suprachoroidal space will play in dosing medicine directly to the site of retinal disease in patients experiencing retinal blindness,” says Daniel White, president and CEO of Clearside Biomedical. “The collaboration with Santen prepares an avenue to develop state-of-the-art medications for the critical treatment of sight-threatening diseases.”
In November 2012, Clearside announced its first successful human dosing with the device in a safety and tolerability study in patients with retinal disease.
The U.S. Food and Drug Administration has allowed Clearside Biomedical to pursue testing related to its Investigational New Drug (IND) Application for CLS1001 (triamcinolone acetonide) Suprachoroidal Injectable Suspension. This IND would treat sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Clinical testing is scheduled to proceed within the next few months.
Samirkumar Patel and Vladimir Zarnitsyn, researchers from the Prausnitz lab who were involved in development of the ocular drug delivery technique, have joined Clearside Biomedical. Edelhauser serves as vice president of scientific affairs and Prausnitz serves on the board of directors of Clearside Biomedical.
The company was formed with the assistance of Georgia Tech’s VentureLab program, Georgia Tech’s center for commercialization, serving faculty, staff and students who want to form startup companies based upon their research or invention.