Suprachoroidal injection of triamcinolone meets primary endpoint in phase 3 trial

MAR 07, 2018

By Keng Jin Lee

Clearside Biomedical

Uveitis

Clearside Biomedical announced that their proprietary formulation of triamcinolone acetonide (CLS-TA) improved vision in patients with macular edema noninfectious uveitis.

Injecting triamcinolone into the suprachoroidal space with a single-use microinjector enabled efficient delivery to the posterior segment, while limiting exposure to the anterior segment.

The phase 3 PEACHTREE trial included 160 patients. Ninety-six were randomized to the treatment arm and received two 4.0 mg doses of suprachoroidal CLS-TA 12 weeks apart. The remaining 64 patients underwent sham procedures at the same 12-week interval. 

At the 24-week follow-up, 47% of CLS-TA patients gained at least 15 ETDRS letters, compared with 16% of controls (P<0.001). The study arm also showed significantly better mean improvements in BCVA (13.7 vs. 2.9 letters) and central subfield thickness (-157 vs. -19 microns) relative to controls.

The treatment was generally well tolerated and produced no serious adverse events.  Through 24 weeks, corticosteroid-related elevated intraocular pressure adverse events were reported for approximately 11.5% of patients in the CLS-TA treatment group, compared with 0% of controls.

“The PEACHTREE study was the first pivotal phase 3 clinical trial of a drug candidate for patients with uveitic macular edema in which a BCVA measure was the primary efficacy endpoint, potentially raising the bar for future trials in this population,” said investigator Rahul N. Khurana, MD, adding that suprachoroidal CLS-TA could potentially shift the treatment paradigm for these patients, pending additional positive results and FDA approval.

Clearside said it expects to file a marketing application with FDA in the fourth quarter of 2018. Suprachoroidal CLS-TA is also being studied for diabetic macular edema and macular edema associated with retinal vein occlusion.   

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