ALPHARETTA, Ga.–(BUSINESS WIRE)–January 5, 2015–
Clearside Biomedical, Inc., a clinical-stage biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye, today announced the enrollment of the first patient in a Phase 2 randomized, controlled, masked, multi-center clinical trial for the treatment of macular edema associated with non-infectious uveitis using Clearside’s proprietary formulation of triamcinolone acetonide, CLS-TA, administered via suprachoroidal (SCS) injection using Clearside’s proprietary microinjector.
Approximately 30 patients will be randomized 1:1 to receive either a single 4.0 mg dose or a single lower dose of 0.8 mg of CLS-TA. The 4.0 mg dose is a commonly used amount when triamcinolone acetonide is dosed intravitreally. The trial is designed to explore safety and efficacy information on SCS injection of each of these doses of CLS-TA.
The primary efficacy endpoint of the Phase 2 trial will be the mean change from baseline in retinal thickness at two months after treatment. Secondary efficacy endpoints will include visual acuity improvements at one-month and two-month’s post-treatment, measured by the mean change in best corrected visual acuity from baseline. Safety measures will be monitored over the two-month observation period and will include the incidence of adverse events and serious adverse events, including increases in intraocular pressure.
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 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. Visit www.clearsidebio.com for more information.
Clearside Biomedical, Inc.
Charles Deignan, 678-270-4005