Clearside Biomedical announced that their proprietary formulation of triamcinolone acetonide (CLS-TA) improved vision in patients with macular edema associated with noninfectious uveitis.
Injected into the suprachoroidal space using a single-use microinjector, the technique enables efficient delivery of triamcinolone to the posterior segment while limiting exposure to the anterior segment.
Drug spread following administration into the suprachoroidal space using Clearside's proprietary microinjector
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.