Clearside Biomedical, Inc. Completes Enrollment in Phase 2 Clinical Trial of CLS-TA Using Suprachoroidal Space (SCS™) Drug Administration

For the Treatment of Macular Edema Associated with Non-Infectious Uveitis

October 12, 2015 07:30 AM Eastern Daylight Time

ALPHARETTA, Ga.-- (BUSINESS WIRE)--Clearside Biomedical, Inc., a clinical-stage biopharmaceutical company developing innovative first-in-class drug therapies to treat blinding diseases of the eye, today announced completion of enrollment in the company’s Phase 2 clinical trial (Dogwood) of CLS-TA, Clearside’s proprietary form of triamcinolone acetonide, using SCS™ drug administration for the treatment of macular edema associated with non-infectious uveitis. Clearside remains on track to report top-line Phase 2 CLS-TA data by the end of 2015.

“I am exceedingly pleased with the efforts of the participating physicians and with our team who contributed to our approach to the treatment for uveitis. We are very excited to announce that we have completed enrollment of the Dogwood trial,” said Daniel H. White, CEO and President of Clearside. “We believe SCS™ drug administration of multiple drugs like CLS-TA may provide superior outcomes for patients suffering from chronic ophthalmic diseases like uveitis.”

The Dogwood trial is the first masked, randomized trial conducted in humans administering drug through the suprachoroidal space. The primary efficacy endpoint of the Dogwood Phase 2 clinical trial is the mean change from baseline in retinal thickness at two months after treatment. Secondary efficacy endpoints include visual acuity improvements at one- and two-months after treatment, measured by the mean change in best corrected visual acuity (BCVA) from baseline. Safety measures are being monitored over the two-month observation period and include the incidence of adverse events and serious adverse events, including increases in IOP.

Drug administration through the SCS potentially provides a route of access from the anterior region of the eye to treat diseases of the back-of-the-eye like uveitis, retinal vein occlusion (RVO), wet age-related macular edema (AMD) and diabetic macular edema (DME). In June 2015, the company met with the U.S. Food and Drug Administration (FDA) to review the ongoing clinical activities and discussed the clinical strategy for CLS-TA using SCS™ drug administration for the treatment of macular edema associated with non-infectious uveitis. Agreement was reached with the FDA for the overall development plan with a single pivotal Phase 3 clinical trial, and the company is planning to enroll the first patient by December 2015.

About Uveitis

Uveitis is inflammation inside the eye, specifically affecting one or more of the three parts of the eye that make up the uvea: the iris (the colored part of the eye); the ciliary body (behind the iris, responsible for manufacturing the fluid inside the eye); and the choroid (the vascular lining tissue underneath the retina). Uveitis is one of the most frequent causes of blindness in the developed world. Based on prevalence data published in the journal Ophthalmology in 2004 and United States census data for 2010, it is estimated approximately 350,000 individuals in the United States suffer from some form of uveitis. Typically diagnosed in individuals between the ages of 20 and 50, uveitis can occur in one or both eyes and accounts for approximately 10% of cases of blindness in the United States, according to a study published in Journal of Ophthalmology. Uveitis can be either infectious or non-infectious. Non-infectious uveitis accounts for approximately 80% of all uveitis cases. Macular edema related to uveitis is the predominant cause of blindness or visual impairment among patients with uveitis, accounting for approximately 30% of cases of blindness in uveitis patients. Because uveitis can become chronic or recurrent if not adequately treated, some patients may become refractory, or unresponsive, to treatment, leading to irreversible blindness.

About Clearside Biomedical, Inc.

Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is a clinical-stage biopharmaceutical company developing innovative first-in-class drug therapies to treat blinding diseases of the eye. Clearside’s product candidates focus on diseases affecting the retina and the choroid, especially diseases associated with macular edema. Clearside holds intellectual property protecting the delivery of drugs of any type through the SCS to reach the delicate tissues of the choroid and retina. Visit www.clearsidebio.com for more information.