Clearside Biomedical Announces Plan to Explore Strategic Alternatives to Advance its Proprietary Suprachoroidal Space Delivery Platform
Clearside Biomedical announced it has initiated a formal process to explore a range of strategic alternatives aimed at maximizing shareholder value and advancing its pipeline.
To support this initiative, Clearside has engaged Piper Sandler to assist in evaluating potential strategic transactions. These may include the sale, licensing, monetization, or divestiture of assets, partnerships, mergers, acquisitions, joint ventures, or other opportunities.
“We strongly believe that our proprietary suprachoroidal delivery platform provides an effective and reliable way to target challenging retinal diseases that need longer lasting treatments,” George Lasezkay, PharmD, JD, President and Chief Executive Officer, said in a company news release. “Our SCS Microinjector enables a proven in-office, repeatable, non-surgical procedure for the targeted delivery of a wide variety of therapies to the macula, retina, and choroid. Based on our retinal expertise and intellectual property, we delivered the first commercial product using our SCS platform, which is now approved and commercialized in the US, approved in Singapore and Australia, and is currently under regulatory review in China and Canada.”
Clearside recently held an end-of-phase 2 meeting with the FDA and aligned on the key elements of a phase 3 program for CLS-AX, an injectable suspension of axitinib for the treatment of wet age-related macular degeneration (AMD). Clearside said the drug candidate showed encouraging safety and efficacy data in earlier studies.
“The CLS-AX ODYSSEY phase 2b trial remains the only tyrosine kinase inhibitor (TKI) study in wet AMD to demonstrate positive safety and efficacy from multiple doses. We are optimistic about the future potential of CLS-AX to reduce the treatment burden for patients with retinal disease,” Dr. Lasezkay said.
As part of its strategic review, Clearside announced it will pause all internal research and development programs and transition all employees—including executive leadership—to consulting roles in order to conserve cash and support ongoing licensing agreements. The company will continue to support partners utilizing its SCS Microinjector in clinical and commercial programs.
“The extraordinary contributions of our Clearside team have led to transformational advances in retinal drug delivery,” Dr. Lasezkay said. “In today’s challenging financial climate, we believe this strategic review is a prudent step toward identifying the best path forward for our platform, our therapies, and ultimately, the patients we serve.”
Clearside's suprachoroidal platform has resulted in the commercial approval of Xipere (triamcinolone acetonide injectable suspension), the first and only therapy approved in the US for suprachoroidal use in uveitic macular edema. The product is also approved in Singapore and Australia, and under regulatory review in China and Canada. Clearside's preclinical programs include candidates for geographic atrophy (GA) and diabetic macular edema (DME) using combinations such as TKI + steroid therapies.
Clearside said that no agreement has been reached, and there is no assurance any transaction will result from the process. The company has not set a timeline and will refrain from providing further updates unless and until its Board of Directors approves a specific course of action.