ALPHARETTA, Ga. — November 24, 2025 — Leads & Copy — Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company focused on revolutionizing therapies for the back of the eye through suprachoroidal space (SCS®) delivery, has filed a voluntary Chapter 11 petition in U.S. Bankruptcy Court.
According to a press release, the filing was made in the U.S. Bankruptcy Court for the District of Delaware. As part of the proceedings, Clearside intends to file a motion seeking authorization to pursue an auction and sale process under Section 363 of the U.S. Bankruptcy Code. This process, if approved by the court, would require interested parties to submit binding offers to acquire Clearside’s assets, free and clear of liens and interests.
George Lasezkay, PharmD, JD, President and CEO of Clearside, stated that the decision to pursue a Chapter 11 structured process came after thorough assessment of strategic options. He said the board and management believe it represents the best option for Clearside and its stakeholders, citing the attractiveness of the company’s assets, including its clinically proven SCS Microinjector® platform, the CLS-AX clinical development program, and multiple suprachoroidal licensing agreements.
Clearside has also filed motions with the court aimed at ensuring normal operations continue during the Chapter 11 process. Cooley LLP and Richards, Layton & Finger, P.A. are serving as legal counsel, while Berkeley Research Group LLC (BRG) is the company’s financial restructuring advisor.
Company Highlights
The company’s SCS Microinjector is designed for targeted delivery of therapies to the macula, retina, or choroid, with the aim of preserving and improving vision in patients with sight-threatening eye diseases. Clearside also possesses commercial-scale manufacturing capabilities for the SCS Microinjector, including ISO and CE mark certifications.
Clearside received FDA approval for XIPERE® (triamcinolone acetonide injectable suspension) for treating uveitic macular edema. A permanent CPT code has been assigned for suprachoroidal injections in the United States, which may allow physicians to receive higher reimbursement for SCS injections.
The CLS-AX (axitinib injectable suspension) program is a proprietary suspension of axitinib for suprachoroidal injection, targeting diseases such as neovascular age-related macular degeneration (wet AMD) and diabetic retinopathy. Suprachoroidal injection of CLS-AX has shown potential in Phase 1/2a and Phase 2b wet AMD clinical trials, with a successful End-of-Phase 2 meeting held with the FDA to discuss a Phase 3 program in wet AMD. The company also has a Phase 2b/3 clinical trial design for CLS-AX in diabetic retinopathy.
Clearside is also evaluating preclinical data on two approaches for Geographic Atrophy (GA): improving choroidal perfusion and modulating pro-inflammatory cells. Suprachoroidal injection allows comprehensive drug coverage while potentially minimizing side effects.
They are also assessing data on a combination of a steroid and a TKI (axitinib formulation) for treating Diabetic Macula Edema (DME).
The company strategically partners its SCS injection platform with companies using other ophthalmic therapeutic agents, including gene therapies and anti-tumor agents. Their SCS Microinjector is being utilized in commercial ophthalmic products and clinical development programs by various companies, including Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO and its global partner AbbVie, and Arctic Vision and its commercial partner Santen.
Assets available for sale related to the Royalty Sub include equity in Clearside Royalty LLC, the right to revenue from Royalties after reaching a revenue cap of $106.5 million, and rights to CLS-AX and other pre-clinical programs.
Additional information about this process and proposed asset auction and sale, as well as other documents related to the restructuring and reorganization proceedings, is available through Clearside’s claims agent, Epiq Bankruptcy Solutions LLC, at https://dm.epiq11.com/ClearsideBiomedical.
Contact: ir@clearsidebio.com
Source: Clearside Biomedical, Inc.
