ALPHARETTA, Ga.--(BUSINESS WIRE)--Clearside Biomedical, Inc., a privately held ophthalmic company developing and commercializing targeted therapeutics for the treatment of sight threatening diseases, announced today that the standard 30-day review period by the U.S. Food and Drug Administration (FDA) relating to Clearside’s Investigational New Drug (IND) Application for CLS1001 (triamcinolone acetonide) Suprachoroidal Injectable Suspension for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids has concluded and clinical testing can proceed.
Clearside Biomedical, Inc. treats the pathological changes to the blood retinal barrier that lead to retinal blindness by delivering therapeutics through the suprachoroidal space using a proprietary microinjection dosage form. This microinjection process allows eye care professionals to treat patients in their offices without complicated surgical techniques. Clearside Biomedical accomplishes targeted drug delivery to the site of disease through a proprietary microinjection platform that allows compartmentalization within the distinct areas of the eye, such as retina and posterior segment via the suprachoroidal space. Clearside Biomedical is currently targeting the initiation of a Phase 1-2 clinical trial in the US in first quarter 2013 to evaluate the safety and tolerability of the product candidate in subjects with non-infectious uveitis.
“Our initial data showed that the microinjection platform is a viable technique for delivering drugs to the retina and choroid within the current standards of medical practice,” said Daniel White, President and CEO of Clearside Biomedical. “We’re looking forward to making progress in this important next step.”
About Clearside Biomedical
Clearside Biomedical, based in Alpharetta, is a clinical-stage ophthalmic pharmaceutical company developing and commercializing targeted therapeutics for the treatment of sight-threatening diseases. Clearside treats the pathological changes to the blood retinal barrier that lead to retinal blindness by delivering therapeutics through the suprachoroidal space using a proprietary microinjection dosage form. Clearside Biomedical was founded by an executive team with extensive development and revenue growth expertise focused on improving the delivery and performance of therapeutic agents to improve the standard of care for patients with retinal and choroidal disease. Visit http://www.clearsidebio.com/ for more information.