Clearside macular edema program headed for submission

Clearside Biomedical Inc. (NASDAQ:CLSD) added $2.51 (32%) to $10.33 on Monday after reporting 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 at least 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)...