Company Description
Clearside Biomedical, Inc. (Nasdaq: CLSD) is a biopharmaceutical company focused on the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). According to the company’s disclosures, its work centers on retinal diseases where sight-threatening pathology often occurs in the macula, retina, and choroid. Clearside is based in Alpharetta, Georgia and its common stock has been listed on The Nasdaq Stock Market LLC under the symbol CLSD.
Clearside has developed a proprietary suprachoroidal space (SCS®) injection platform that uses its patented SCS Microinjector®. Company materials describe this as an in-office, repeatable, non-surgical procedure designed for targeted and compartmentalized delivery of therapies to the back of the eye. The SCS Microinjector consists of a syringe with a custom-designed hub and two 30-gauge hollow microneedles of approximately one millimeter in length, intended to optimize insertion and suprachoroidal administration of drugs. The platform is described as capable of delivering a wide variety of drug candidates into the SCS to potentially improve efficacy and limit exposure of medication to non-diseased tissues.
Through this platform, Clearside targets multiple retinal and macular diseases. Company descriptions state that its approach is designed for conditions such as neovascular age-related macular degeneration (wet AMD), diabetic retinopathy, diabetic macular edema, geographic atrophy, uveitic macular edema, and certain ocular cancers. By compartmentalizing drugs behind the retina, the company reports the potential to achieve prolonged duration of effect and to minimize systemic and anterior segment side effects relative to less targeted delivery approaches.
Commercial Product: XIPERE®
Clearside developed and obtained U.S. Food and Drug Administration (FDA) approval for its first commercial product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use. Company communications state that XIPERE is a proprietary suspension of the corticosteroid triamcinolone acetonide for administration to the suprachoroidal space for the treatment of macular edema associated with uveitis. XIPERE is approved by the FDA and is commercially available in the United States through a commercial partner. The company also reports that XIPERE has been approved for use in additional markets, including Canada, Australia, and Singapore, and that it is under regulatory review in China.
Clearside has licensed commercialization and development rights for XIPERE in various territories. According to company press releases, Bausch + Lomb has the exclusive license for XIPERE in the United States and Canada. Arctic Vision holds exclusive rights in Greater China, South Korea, Australia, New Zealand, India and certain ASEAN countries, where the product is referred to as ARCATUS® or ARVN001. These arrangements are tied to Clearside’s SCS Microinjector technology and generate royalty and milestone payment streams under license agreements.
Lead Development Program: CLS-AX (axitinib injectable suspension)
The company’s lead internal development asset is CLS-AX (axitinib injectable suspension), described as a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is characterized in Clearside’s materials as a tyrosine kinase inhibitor (TKI) that achieves pan-VEGF blockade by directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside reports that CLS-AX is being developed as a longer-acting therapy for serious back-of-the-eye diseases, particularly neovascular age-related macular degeneration (wet AMD), and has also outlined a development path in diabetic retinopathy.
Company disclosures state that suprachoroidal injection of CLS-AX has demonstrated meaningful potential in Phase 1/2a and Phase 2b wet AMD clinical trials, with data supporting potential efficacy, safety, and versatility in this chronic disease setting. Clearside has reported a successful End-of-Phase 2 meeting with the FDA and alignment on essential components of a potential Phase 3 program in wet AMD, including a design intended to offer dosing flexibility similar to anti-VEGF biologics while aiming for extended durability associated with a TKI. The company has also described a Phase 2b/3 clinical trial design for CLS-AX in diabetic retinopathy.
Preclinical Small Molecule Programs
Beyond CLS-AX, Clearside describes internal preclinical programs that use suprachoroidal delivery of small molecules for retinal diseases with high unmet medical need. The company has reported that it is evaluating approaches for geographic atrophy (GA), including strategies focused on improving choroidal perfusion and modulating pro-inflammatory cells. It has also described preclinical evaluation of a combination of a steroid plus a TKI (an axitinib formulation) for the treatment of diabetic macular edema (DME), which is characterized in company materials as a common cause of vision loss in people with diabetes due to fluid accumulation and retinal swelling.
According to Clearside’s descriptions, suprachoroidal delivery of these small molecules is intended to provide comprehensive drug coverage of both the retina and choroid while potentially reducing systemic and anterior segment side effects. These programs are positioned as potential long-acting treatments that leverage the same SCS Microinjector platform used for XIPERE and CLS-AX.
External Licensing and Collaboration
Clearside also pursues an external licensing model for its SCS injection platform. Company press releases state that the SCS Microinjector is used in commercial ophthalmic products and in clinical development programs run by partners. Named partners include Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO and its global partner AbbVie, and Arctic Vision and its commercial partner Santen. These collaborations involve a range of ophthalmic therapeutic agents, including gene therapies and anti-tumor agents, delivered via the suprachoroidal route.
To support monetization of its royalty streams, Clearside formed a wholly owned subsidiary, Clearside Royalty LLC (referred to as “Royalty Sub” in SEC filings). Under an August 2022 Purchase and Sale Agreement with entities managed by HealthCare Royalty Management, LLC, the subsidiary sold certain rights to receive royalty and milestone payments related to XIPERE and the SCS Microinjector technology. Subsequent amendments, as disclosed in an 8-K filing, adjusted the aggregate royalty cap and transferred additional assets related to the SCS Microinjector in exchange for additional consideration and modified terms.
Suprachoroidal Platform Characteristics
Across its disclosures, Clearside emphasizes several characteristics of its SCS platform. The SCS Microinjector is described as enabling in-office administration by eye care professionals, with a procedure that can be repeated and does not require surgery. The suprachoroidal space is presented as offering direct access to tissues at the back of the eye, potentially allowing higher local drug concentrations where disease is active and reduced exposure elsewhere. Company materials also reference a permanent CPT code in the United States for suprachoroidal injections, which they note may permit physicians to receive higher reimbursement for administering drugs into the SCS compared with injections into the vitreous.
Clearside has also reported development of supporting technologies and training around its platform. In scientific and medical meeting communications, the company has described a clinically validated suprachoroidal injection training program using synthetic eye models, machine learning algorithms for imaging the opening of the SCS after drug delivery, and force analysis methods to evaluate injectability of suspensions and optimize drug-device combinations. These efforts are presented as part of the company’s broader expertise in suprachoroidal drug delivery.
Corporate and Trading Status
According to a Form 8-K filed with the U.S. Securities and Exchange Commission on November 25, 2025, Clearside Biomedical, Inc. filed a voluntary petition for relief under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware on November 23, 2025 (Case No. 25-12109). The filing states that the company intends to operate as a debtor-in-possession under court supervision and that its objective in the case is to consummate a sale of substantially all of its assets to the highest bidder through a court-supervised process.
The same 8-K discloses that on November 24, 2025, The Nasdaq Stock Market LLC notified Clearside that, as a result of the Chapter 11 case and in light of prior listing compliance issues, Nasdaq had determined that the company’s common stock would be delisted. Trading of the common stock on Nasdaq is scheduled to be suspended at the opening of business on December 1, 2025, with a Form 25-NSE to be filed. The filing further states that the company does not intend to appeal the determination and that, following suspension from Nasdaq, the common stock is expected to trade exclusively on the over-the-counter (OTC) market under the symbol CLSDQ.
Prior to the bankruptcy-related delisting notice, Clearside had received Nasdaq notices regarding non-compliance with minimum bid price and market value of listed securities requirements. Company 8-K filings describe stockholder approval of a reverse stock split, a subsequent one-for-fifteen reverse stock split and reduction in authorized shares, and an initial determination that the company had regained compliance with the minimum bid price rule following the reverse split.
Strategic Review and Chapter 11 Sale Process
In mid-2025, Clearside announced plans to explore strategic alternatives for its SCS platform and ophthalmology pipeline, including potential sale, licensing, monetization, divestiture of assets, collaborations, partnerships, mergers, acquisitions, joint ventures or other transactions. Later in the year, in connection with its Chapter 11 filing, the company disclosed its intent to seek court approval for an auction and sale process under Section 363 of the Bankruptcy Code. Under the proposed procedures, interested parties would be required to submit binding offers to acquire Clearside’s assets in whole or in part, free and clear of liens and interests, subject to court approval.
As part of the Chapter 11 process, Clearside has filed motions seeking first-day relief to support continuation of operations during the case. The company has indicated that its assets include its SCS Microinjector platform and related intellectual property, its CLS-AX clinical program, preclinical programs targeting geographic atrophy and diabetic macular edema, and rights associated with royalty and milestone payments through its Royalty Sub structure, subject to existing agreements and caps described in SEC filings.
FAQs about Clearside Biomedical, Inc. (CLSD)
- What does Clearside Biomedical, Inc. do?
Clearside Biomedical, Inc. is a biopharmaceutical company that focuses on delivering therapies to the back of the eye through the suprachoroidal space (SCS®). It has developed a patented SCS injection platform using its SCS Microinjector® to administer drugs to the macula, retina, or choroid for sight-threatening eye diseases. - What is Clearside’s main technology platform?
The company’s main technology platform is its suprachoroidal space (SCS®) injection system, centered on the SCS Microinjector®. This device uses microneedles to deliver drug formulations into the SCS in an in-office, repeatable, non-surgical procedure, aiming for targeted and compartmentalized drug delivery at the back of the eye. - What is XIPERE® and how is it used?
XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use is Clearside’s first approved product. It is a proprietary suspension of the corticosteroid triamcinolone acetonide administered into the suprachoroidal space for the treatment of macular edema associated with uveitis. XIPERE is approved by the U.S. FDA and is commercially available in the United States through a licensee. It has also received approvals in Canada, Australia, and Singapore and is under review in China. - What is CLS-AX (axitinib injectable suspension)?
CLS-AX is Clearside’s lead development program. It is a proprietary suspension of the tyrosine kinase inhibitor axitinib formulated for suprachoroidal injection. Company materials state that CLS-AX is being developed as a longer-acting therapy for neovascular age-related macular degeneration (wet AMD) and has shown meaningful potential in Phase 1/2a and Phase 2b clinical trials, with FDA alignment on a potential Phase 3 program. - Which eye diseases does Clearside target with its platform?
According to its public statements, Clearside’s suprachoroidal platform is designed for retinal and macular diseases such as wet AMD, diabetic retinopathy, diabetic macular edema, geographic atrophy, uveitic macular edema, and certain ocular cancers. The goal is to deliver drugs directly to affected tissues at the back of the eye. - Who are some of Clearside’s partners?
Clearside reports that its SCS Microinjector is used in commercial products and clinical programs run by partners including Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO and its global partner AbbVie, and Arctic Vision and its commercial partner Santen. These collaborations involve suprachoroidal delivery of various ophthalmic therapeutic agents. - How does Clearside generate revenue from its technology?
Company disclosures describe license and other revenue from partners, including royalty and milestone payments related to XIPERE and the SCS Microinjector technology, as well as revenue from training, services and sales of SCS Microinjector kits to licensees. Certain royalty and milestone rights have been sold to entities managed by HealthCare Royalty Management, LLC through Clearside’s subsidiary Clearside Royalty LLC, subject to specified caps and terms. - What is Clearside’s current corporate status?
A Form 8-K filed on November 25, 2025 states that Clearside filed a voluntary petition for relief under Chapter 11 of the U.S. Bankruptcy Code on November 23, 2025. The company is operating as a debtor-in-possession under the supervision of the U.S. Bankruptcy Court for the District of Delaware, with the stated objective of pursuing a sale of substantially all of its assets through a court-supervised process. - Is CLSD still listed on Nasdaq?
In the same November 25, 2025 Form 8-K, Clearside reports that Nasdaq notified the company that its common stock would be delisted as a result of the Chapter 11 case and prior listing compliance concerns. Trading on Nasdaq is scheduled to be suspended at the opening of business on December 1, 2025, and the company does not intend to appeal. The filing states that the common stock is expected to trade exclusively on the over-the-counter market under the symbol CLSDQ. - What should investors know about Clearside’s Chapter 11 process?
According to the company’s 8-K and press release, Clearside’s Chapter 11 case is intended to facilitate an auction and sale process under Section 363 of the Bankruptcy Code, allowing potential buyers to submit binding offers for its assets. The company has filed first-day motions to support continued operations during the case. Additional information, including court documents and updates on the restructuring and potential asset sale, is made available through a claims agent website referenced in the company’s filings.