Clearside Starts Strategic Review for SCS Platform

Clearside Biomedical has announced the initiation of a formal strategic review to explore multiple potential pathways that could enhance shareholder value and further the development of its proprietary suprachoroidal space (SCS®) delivery platform. This process aims to align the company’s long-term growth with emerging opportunities in retinal drug delivery.

Strategic Review Led by Piper Sandler

To facilitate this initiative, Clearside has engaged investment bank Piper Sandler to assist in evaluating a broad spectrum of strategic transactions. These may include the sale, licensing, monetization, or divestiture of key assets, as well as strategic partnerships, mergers, acquisitions, or joint ventures. The company emphasized that the goal is to ensure its innovative delivery platform continues to be leveraged for both clinical and commercial advancements.

CEO Highlights Value of Suprachoroidal Technology

George Lasezkay, PharmD, JD, President and CEO of Clearside Biomedical, reaffirmed the company’s commitment to its proprietary delivery platform. According to Lasezkay, the SCS Microinjector® allows for an in-office, repeatable, and non-surgical method to deliver therapies directly to the macula, retina, and choroid. He stated that this approach offers a reliable way to treat retinal diseases that require sustained therapeutic activity.

Lasezkay also noted that Clearside’s platform has already resulted in a commercial product: Xipere (triamcinolone acetonide injectable suspension), which is currently approved and marketed in the United States, Singapore, and Australia. Xipere remains under regulatory review in both China and Canada.

CLS-AX Advancing Toward Phase 3

Clearside recently concluded an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA), during which agreement was reached on the key components of a phase 3 clinical program for CLS-AX. This investigational therapy is an injectable suspension of axitinib, a tyrosine kinase inhibitor (TKI), designed for the treatment of wet age-related macular degeneration (AMD).

The company reported that CLS-AX has shown favorable safety and efficacy data in earlier studies. The ODYSSEY phase 2b trial is currently the only TKI-based clinical trial in wet AMD to demonstrate positive safety and efficacy outcomes from multiple doses. Lasezkay expressed optimism regarding the potential of CLS-AX to reduce the treatment burden for patients with retinal disease.

Internal Restructuring to Conserve Resources

As part of the ongoing strategic review, Clearside has announced it will pause all internal research and development programs. In parallel, the company will transition all employees—including executive leadership—into consulting roles. This measure is aimed at conserving capital while continuing to support existing and future licensing agreements with partners utilizing the SCS Microinjector in both clinical and commercial programs.

Suprachoroidal Platform and Preclinical Pipeline

Clearside’s suprachoroidal delivery platform has not only supported the approval of Xipere but also laid the foundation for a growing preclinical pipeline. The company is developing candidates for geographic atrophy (GA) and diabetic macular edema (DME), including therapies that combine TKI and steroid mechanisms—underscoring the platform’s adaptability to complex retinal conditions.

No Timeline or Assurances Provided

Clearside clarified that, as of now, no agreement has been reached, and there is no certainty that any transaction will result from the strategic review. The company has not set a specific timeline for the process and does not plan to issue further updates unless or until the Board of Directors approves a definitive course of action.