The FDA decision on Clearside Biomedical Inc’s (CLSD) Xipere, proposed for the treatment of macular edema associated with uveitis, is expected on October 30, 2021.Xipere is a proprietary suprachoroidal injectable suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye using a specially-designed SCS microinjector. SCS or suprachoroidal space is located between the choroid and the outer protective layer of the eye, known as the sclera.This is Xipere’s second go-around with the FDA. In August 2019, the regulatory agency had declined to approve Xipere and requested the company to provide stability data on its new manufacturing process for Xipere’s triamcinolone acetonide suspension. Under an agreement signed in 2019, Bausch + Lomb has exclusive license to Xipere in United States and Canada, and exclusive options for the right to commercialize and develop Xipere in Europe, the United Kingdom, Australia, New Zealand, South America and Mexico.If approved, Xipere could achieve peak sales of over $100 million in the indication of uveitic macular edema, according to analysts.CLSD closed Wednesday’s (Sep.29, 2021) trading at $5.88, down 3.13%.