Clearside closes patient enrolment in Phase II Dogwood trial of CLS-TA to treat macular edema

12th October 2015 (Last Updated October 12th, 2015 18:30)

US clinical-stage biopharmaceutical firm Clearside Biomedical has completed patient enrolment in its Phase II clinical trial (Dogwood) of CLS-TA, its proprietary form of triamcinolone acetonide, to treat macular edema associated with non-infectious uveitis.

US clinical-stage biopharmaceutical firm Clearside Biomedical has completed patient enrolment in its Phase II clinical trial (Dogwood) of CLS-TA, its proprietary form of triamcinolone acetonide, to treat macular edema associated with non-infectious uveitis.

Patient enrolment has been completed using suprachoroidal space (SCS) drug administration in the trial, which is designed to evaluate CLS-TA these patients..

The company noted that top-line Phase II CLS-TA data will be published by the end of this year.

The Dogwood study is claimed to be the first masked, randomised trial conducted in humans administering drug through the SCS.

Drug administration through SCS is said to provide a route-of-access from the anterior region of the eye to treat diseases of the back-of-the-eye, such as 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.

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."

"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's primary efficacy endpoint is the mean change from baseline in retinal thickness at two months after treatment.

Secondary efficacy endpoints of the trial include 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 noted that 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.