Clearside Biomedical – FDA Regulatory Review Helps Company in its Successful IPO

Challenge

Located in metro Atlanta, Georgia, Clearside Biomedical is developing a prescription ophthalmic drug product. Clearside Biomedical is a clinical biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye. The company announced an initial public offering in 2016 to fund research and development of the lead product. Arnall Golden Gregory was tapped to conduct the regulatory section review of the IPO.

Approach

The regulatory section review focused primarily on FDA regulatory strategy, as the product is not yet FDA approved. AGG reviewed the meeting notes with FDA, had discussions with company officials, revised and prepared the underwriter counsel’s summary of FDA laws and regulations, and provided an opinion letter for the underwriter.

Result

Clearside Biomedical was listed on NASDAQ (CLSD) in December 2016. The client showed its appreciation for AGG’s work by inviting the lead attorney for FDA matters, Alan Minsk, to a reception celebrating the IPO launch. The company’s development of treatments for eye disease continue.