Clearside Biomedical's eye disease treatment gets FDA approval
Mar 14th 2023, 1:22 pm
Part 1: Analysis of the Company's Performance Clearside Biomedical, Inc. is a biopharmaceutical company that focuses on developing treatments for chorioretinal diseases. The company's proprietary suprachoroidal injection technology is a targeted and compartmentalized delivery system aiming to improve and preserve vision. The company announced its approval for XIPERE, a therapeutic agent for the treatment of macular edema in patients with uveitis, by the FDA in October 2021. It is the first approved commercial product that Clearside Biomedical has developed, and it marks the company's success in the eye disease area. In addition, the company is developing small molecule product candidates for administration via its SCS microinjector, and it also has external collaborations with other ophthalmic therapeutic innovations to be administered using its SCS injection platform. Clearside Biomedical prioritizes its research and development projects to obtain regulatory approval of its product candidates, including the completion of clinical development of the CLS-AX product, and developing proprietary therapeutics to utilize with its SCS Microinjector. As of December 31, 2022, Clearside Biomedical had an accumulated deficit of $288.3 million. It recorded net losses of $32.9 million for the year ended December 31, 2022, net income of $0.4 million in 2021, and net losses of $18.2 million for the year ended December 31, 2020. Part 2: Forward-Looking Analysis Clearside Biomedical will need to continue its research and development to gain FDA approval for its CLS-AX product and to conduct additional clinical trials. The company's revenue has been primarily generated from its license agreements, but it does not expect to generate any product revenue until it obtains regulatory approval for its product candidates, either on its own or through partnerships. Clearside Biomedical is seeking to enter into additional license and other agreements with third parties to evaluate the potential use of its proprietary SCS Microinjector with other product candidates for the treatment of various eye diseases. These agreements may include payments to the company for technology access, upfront license payments, regulatory and commercial milestone payments, and royalties. Clearside Biomedical intends to continue its efforts to discover, research, and develop additional product candidates and seek regulatory approvals in additional regions for XIPERE for the treatment of macular edema associated with uveitis. Based on the company's current research and development plans, it expects to have sufficient resources to fund its planned operations into the second quarter of 2024. However, Clearside Biomedical will require additional capital to complete clinical development of CLS-AX. Overall, Clearside Biomedical's proprietary suprachoroidal injection technology presents an exciting opportunity for drug delivery in the ophthalmic field. The FDA approval of XIPERE is a vital milestone for the company, and it appears well-positioned to develop additional products using its SCS microinjector. The company's ability to secure additional strategic partnerships, complete clinical development of CLS-AX, and obtain regulatory approval of additional product candidates will all be critical factors for its future success. Investors should be mindful that the company's operations will continue to generate losses in the foreseeable future as it focuses on research and development activities.