Clearside’s Phase II Trial for DME Candidate Meets Primary Endpoint

June 8, 2018: By Jon Swedien

Clearside Biomedical’s Phase II study of suprachoroidal CLS-TA used with Eylea to treat diabetic macular edema (DME) met its primary endpoint, the company reported May 31.

CLS-TA is Clearside’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space.

TYBEE—the multicenter, randomized, masked, controlled study—enrolled 71 patients who were naïve to DME treatment, and randomized them 1:1 to a combination arm or a control arm.

The combination arm received treatments of suprachoroidal CLS-TA together with intravitreal Eylea injections (two injections) at the beginning of the study and at the three-month mark.

Patients in the control arm received Eylea and a sham suprachoroidal procedure at the beginning of the study and at the one-, two, and three-month mark.

Patients in both arms were treated with Eylea at the four- and five-month marks if they needed it.

Clearside said the trial met its primary endpoint of mean improvement in best corrected visual acuity (BCVA) from baseline over six months, as measured using the Early Treatment of Diabetic Retinopathy Trial (ETDRS) scale.

Patients in the combination arm gained an average of 12.3 ETDRS letters compared with 13.5 ETDRS letters in the Eylea alone control arm (p = 0.664).

Clearside CEO Daniel White said the data suggests that suprachoroidal CLS-TA paired with an anti-VEGF agent could provide a longer response to treatment and substantially lower the treatment frequency.

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