Steroids remain the fastest acting and most potent agent for the management of noninfectious uveitis. However, use of this class of drugs is limited by side effects including ocular hypertension, glaucoma, and cataract. Uveitis specialists have struggled to find a balance between the benefits and risks of steroid use. New phase 2 research, however, shows that a novel method of steroid delivery may be highly efficacious and result in minimal side effects.

PHASE 2 STUDY OF SUPRACHOROIDAL TA

CLS-TA is a proprietary form of triamcinolone acetonide from Clearside Biomedical. In a randomized, masked, controlled, multicenter study, researchers randomized 22 patients with uveitis to suprachoroidal injections of either 4.0 mg or 0.8 mg CLS-TA. At baseline, patients had mean 526 µm central subfield thickness (CST).

At the 1-month and 2-month time points, patients in the 4.0-mg arm demonstrated significantly decreased CST; at 1 month, mean change in CST from baseline was 135 µm, and at 2 months it was 164 µm (both P < .01). At 2 months, 69% of patients demonstrated at least a 20% reduction in CST, and 56% of patients demonstrated CST of less than 310 µm.

The safety profile in patients in the 4.0-mg arm showed that 47% of patients experienced at least 1 one adverse event, including conjunctival hemorrhage, conjunctival edema, eye pain, and intraocular pressure increases (researchers did not attribute pressure elevation to CLS-TA). No severe adverse events occurred during the study in this group.

These data suggest that suprachoroidal administration of CLS-TA may be a safe and effective treatment for patients with noninfectious uveitis. Injection of steroid into the suprachoroidal space was well tolerated and produced a significant reduction in CST at 2 months. A phase 3 study is currently enrolling.

 

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