In the phase 1/2 clinical study, eight patients diagnosed with non-infectious uveitis at three U.S. study centers received a single suprachoroidal injection of a formulation of preservative-free triamcinolone acetonide injectable suspension using Clearside’s proprietary microinjector. Of the eight patients treated in the trial, seven were experiencing macular edema at the time of treatment and were therefore evaluated for change in retinal thickness after the injection. All seven of these patients achieved clinically meaningful reduction in retinal thickness of at least 50 microns from their respective baselines at week 8. Five of these seven patients experienced a reduction in retinal thickness to below 310 microns, which represents the maximum retinal thickness for approximately 95% of the population with normal retinas. Regarding best-corrected visual acuity (BCVA), all eight patients have shown clinically meaningful improvement of five or more letters in BCVA at week 8, while five of the eight patients have improved by at least 15 letters at week 8.
The suprachoroidal injection of triamcinolone acetonide appeared generally well tolerated in all eight patients in this study. No patient in the study has experienced a clinically meaningful increase in intraocular pressure, a commonly known complication associated with intraocular or periocular administration of corticosteroids.
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 chronic, 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