Privately-owned ophthalmic company Clearside Biomedical has gained the go-ahead from the FDA to begin clinical trials of CLS1001, an injectable formulation of triamcinolone using its microneedle technology.
CLS1001 is in development for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. The initial Phase I/II trial will take place in the U.S. in patients with non-infectious uveitis.
Clearside's microinjection technology gets drugs between the sclera (the white part of the eye) and the choroid (the vascular tissue between the sclera and the retina), allowing them to get to the back of the eye where they are needed. Microneedles less than a millimeter long are less invasive than intravitreal injection with a hypodermic needle, more convenient than eye drops, especially in elderly people who are more likely to develop eye disease, and more likely to get drugs to the right place than formulations applied to the surface of the eye.
Clearside raised $4 million in Series A venture financing in January 2012, and its technology grew out of a collaboration between Georgia Institute of Technology and Emory University School of Medicine.
- read the press release