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news.Clinical-stage biopharmaceutical firm Clearside Biomedical has completed the enrollment of patients in its Phase II clinical trial (Dogwood) of CLS-TA, a proprietary form of triamcinolone acetonide.
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The firm has enrolled the patients using suprachoroidal space (SPS) drug administration in the trial, which is designed to assess CLS-TA to treat macular edema associated with non-infectious uveitis.
Drug administration through SCS is said to offer 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 this year, the firm met with the US 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.
The Dogwood is a randomized trial, in which the primary efficacy endpoint is the mean change from baseline in retinal thickness at two months after treatment.
Secondary efficacy endpoints comprise of visual acuity improvements at one- and two-months after treatment, assessed by the mean change in best corrected visual acuity (BCVA) from baseline.
The company plans to reveal the data from Phase II CLS-TA by the end of this year.
Clearside CEO and president Daniel White said: "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 believe SCS drug administration of multiple drugs like CLS-TA may provide superior outcomes for patients suffering from chronic ophthalmic diseases like uveitis."