Clearside macular edema program headed for submission

Clearside Biomedical Inc. (NASDAQ:CLSD) reported that suprachoroidal CLS-TA met the primary endpoint in the Phase III PEACHTREE trial to treat macular edema associated with non-infectious uveitis. Clearside plans to submit an NDA to FDA in 4Q18 for the suspension of triamcinolone acetonide delivered using the company's suprachoroidal space microinjector.

On the 160-patient trial's primary endpoint, a significantly greater proportion of patients who received two unilateral suprachoroidal injections of 4 mg CLS-TA given 12 weeks apart gained ≥15 letters in best corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at week 24 vs. sham procedure (46.9% vs. 15.6%, p<0.001)...