Investor Overview

Clearside Biomedical, Inc. is a privately-held ophthalmic pharmaceutical company dedicated to developing and commercializing therapeutics that safely treat diseases of the posterior (back) segment of the eye like macular edema, wet AMD and inflammation.  The Company’s patented microinjection dosage form is the only non-surgical method for focal delivery of drugs to the retina and choroid through the suprachoroidal space (SCS).  Clearside Biomedical has initiated clinical development of its lead product in macular edema following non-infectious uveitis and following retinal vein occlusion, expanded its internal drug development efforts in steroid-sparing anti-inflammatory drugs as well as multikinase inhibitors for wet AMD, and entered into a collaboration with Santen Pharmaceuticals Co., Ltd.

The company reports that these milestones have been reached:

  • Successful IND filing and initiated a Phase I/II study in macular edema following non-infectious uveitis with a Phase II trial in macular edema following retinal vein occlusion to begin enrollment before the end 3Q2014.
  • Evaluated and tested a broad portfolio of compounds for wet AMD and posterior inflammation.
  • In 2014 will take most promising candidates into pre-clinical development.
  • Company established with a $12 million investment from Hatteras Venture Partners, Santen Pharmaceuticals Co., Ltd., Kenan Flagler Venture Fund, Mountain Group Capital and Georgia Research Alliance Venture Fund.
  • Proprietary microinjection dosage form targeting the retina and choroid through the suprachoroidal space (SCS).
  • Three US patents issued and international intellectual property secured encompassing drug delivery into the SCS with microinjection dosage form.
  • Successfully completed a human safety/tolerability study of SCS delivery with multiple drugs.
  • Financing and research collaboration agreements for posterior ocular disease signed with Santen Pharmaceuticals Co., Ltd. in January 2013.

In January 2012, Clearside announced $4 million Series A financing from Hatteras Venture Partners, a venture capital firm based in Research Triangle Park, N.C. Hatteras Venture Partners focuses on seed and early stage prospects in biopharmaceuticals, medical devices, diagnostics, and related opportunities in human medicine. This financing is funding the development of Clearside Biomedical’s ocular microinjection platform, the initial clinical testing of the company’s lead product for inflammation and the establishment of Clearside Biomedicals’ team of scientific experts in offices in Alpharetta and Raleigh.

The Hatteras Venture Partners team brings operational experience, a successful track record, and a proven ability to enhance the value of the companies in which it invests. With four funds, the firm has more than $200 million under management.

“Clearside Biomedical represents an ideal fit for Hatteras Discovery,” said Christy Shaffer, Ph.D., Venture Partner and Managing Director of Hatteras Discovery, and Chairman of the Board of Clearside Biomedical. ”The platform technology is highly innovative and based on elegant science. The lead product is expected to be in clinical trials in the U.S. in 2013.”

The microinjection platform was developed cooperatively by the laboratories of Mark Prausnitz, Ph.D., Regents’ Professor and Love Family Professor of Chemical & Biomolecular Engineering at the Georgia Institute of Technology, and Henry Edelhauser, Ph.D., Emeritus Professor in the Department of Ophthalmology at Emory University School of Medicine.

The research was supported by the National Eye Institute, which is part of the National Institutes of Health, and by the organization Research to Prevent Blindness.

The researchers’ study was reported in the July, 2012 issue of Investigative Ophthalmology & Visual Science. In addition to demonstrating that microneedles can deliver drug molecules and particles to the eye, the study established that the suprachoroidal space could accommodate a variety of drugs and microparticles. This finding could lead to the use of timed-release drugs that may reduce the need for frequent injections to treat chronic eye diseases.