Clearside Biomedical is pioneering a novel approach to treating retinal diseases through its proprietary suprachoroidal administration technology. This method allows for precise drug delivery directly to the back of the eye, specifically targeting the suprachoroidal space (SCS). By injecting fluid between the choroid and sclera, the drug can spread spherically to reach diseased tissues, enhancing absorption and efficacy. The company’s first FDA-approved product, XIPERE® (triamcinolone acetonide injectable suspension), is designed for suprachoroidal use and addresses macular edema associated with uveitis, marking a significant advancement in ocular therapeutics.

In addition to XIPERE®, Clearside is developing CLS-AX, an injectable suspension of axitinib, a potent tyrosine kinase inhibitor (TKI) aimed at treating various VEGF-driven disorders, including wet age-related macular degeneration (AMD) and diabetic macular edema. The SCS Microinjector facilitates targeted delivery of CLS-AX, which compartmentalizes the drug away from the vitreous and anterior chamber, potentially reducing side effects and improving patient comfort. This innovative delivery system aims to provide longer-lasting therapeutic effects, thereby decreasing the treatment burden on patients who currently face frequent injections with existing therapies.

United States

Clearside Biomedical, Inc., a biopharmaceutical company, engages in the developing and delivering treatments that restore and preserve vision for people with serious eye diseases. Its product includes CLS-AX, an axitinib for suprachoroidal injection which is in Phase 1/2a clinical trial. It also develops XIPERE, a triamcinolone acetonide suprachoroidal injectable suspension for the treatment of macular edema associated with uveitis, diabetic macular edema, and macular edema associated with retinal vein occlusion. The company was incorporated in 2011 and is headquartered in Alpharetta, Georgia.

Cancer

Eye Diseases

Clearside Biomedical

Macular edema

XIPERE™&nbsp;(triamcinolone &nbsp;acetonide suprachoroidal injectable suspension), formerly known as &nbsp;CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone &nbsp;acetonide formulated for administration to the back of the eye and being &nbsp;investigated for the treatment of macular edema associated with &nbsp;non-infectious uveitis. Clearside’s patented technology is designed to &nbsp;deliver drug to the suprachoroidal space located between the choroid and &nbsp;the outer protective layer of the eye, known as the sclera. &nbsp;Suprachoroidal injection enables the rapid and adequate dispersion of &nbsp;medicine to the back of the eye, offering the potential for the medicine &nbsp;to act longer and minimize harm to the surrounding healthy parts of the &nbsp;eye. Bausch + Lomb, a leading global eye health business of Bausch &nbsp;Health&nbsp;Companies Inc. (“Bausch Health”) (NYSE/TSX: BHC), has the &nbsp;exclusive license for the commercialization and development of XIPERE in &nbsp;the United States and Canada and exclusive options for the right to &nbsp;commercialize and develop XIPERE in Europe and the United Kingdom, &nbsp;Australia and New Zealand, and South America and Mexico (through a &nbsp;license agreement between Clearside and Bausch Health’s affiliate). &nbsp;Arctic Vision, a specialty ophthalmology company based in China, has the &nbsp;exclusive license for the commercialization and development of XIPERE &nbsp;in Greater China and South Korea.
<a href="https://ir.clearsidebio.com/news-releases/news-release-details/clearside-biomedical-announces-clinical-data-presentations">Source</a>

XIPERE (CLS-TA) 

Age-related macular degeneration

Wet age-related macular degeneration

CLS-AX (axitinib injectable suspension) is a &nbsp;proprietary suspension of axitinib for suprachoroidal injection. &nbsp;Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to &nbsp;treat renal cell cancer that achieves pan-VEGF blockade, directly &nbsp;inhibiting VEGF receptors-1, -2, and -3 with high potency and &nbsp;specificity. Clearside believes this broad VEGF blockade may have &nbsp;efficacy advantages over existing retinal therapies by acting at a &nbsp;different level of the angiogenesis cascade, and may benefit patients &nbsp;who sub-optimally respond to current, more narrowly focused anti-VEGF &nbsp;therapies. Suprachoroidal injection of this proprietary suspension of &nbsp;axitinib has demonstrated meaningful potential in preclinical studies in &nbsp;multiple species. Preclinical results from Clearside and independent &nbsp;investigators have shown pharmacodynamic effects with reduced growth of &nbsp;experimental neovascularization and decreased fluorescein leakage. With &nbsp;suprachoroidal administration of axitinib, there is the potential to &nbsp;achieve prolonged duration and targeted delivery to affected tissue &nbsp;layers. Clearside is developing CLS-AX as a long-acting therapy for the &nbsp;treatment of wet AMD. CLS-AX is currently being investigated in an &nbsp;ongoing U.S.-based, multi-center, open-label, dose-escalation, Phase &nbsp;1/2a, safety and tolerability study, entitled OASIS, in wet AMD &nbsp;patients, and additional information can be found on <a href="https://www.globenewswire.com/Tracker?data=mqI0-a8y5Q3yoZ6IFcr9HpHr1yWu2OBx98lJyJXHC3xSreFzUw2HTCjEooTXmDJQSOZQy0Os89OKtviK0-B4dHEty93Ri4H0zqJOnN3gIcs=" rel="nofollow" target="_blank">https://clinicaltrials.gov</a> (<a href="https://www.globenewswire.com/Tracker?data=XHubTZ58abnB2QP1_BTFCBjz4xkmTGk0ii5EtmRTmIHaxGjAR9UXySbm43ViW9ZBjDW1q4h0aJ3D1Cg3bE9VpFJGSaCqg33-3Lbkt_h7VvdIUuFfz-gZ9FLKJhDwLBcOLVkxjWqvM15vNs59LYOVsA==" rel="nofollow" target="_blank">NCT04626128</a>).
<a href="https://ir.clearsidebio.com/news-releases/news-release-details/clearside-biomedical-announces-completion-patient-dosing-first">Source&nbsp;</a>

CLS-AX 

Primary Choroidal Melanoma

The AU-011 clinical program is supported by extensive preclinical &nbsp;research that demonstrated that this novel therapy binds selectively to &nbsp;tumor cells.&nbsp; Aura’s preclinical data has also shown that &nbsp;photoactivation of AU-011 using an infrared laser results in very &nbsp;focused tumor cell necrosis and a secondary anti-tumor immune response &nbsp;in animal models.
Clearside’s patented, proprietary suprachoroidal &nbsp;space (SCS) injection treatment approach offers unprecedented access to &nbsp;the back of the eye where sight-threatening disease often occurs. The &nbsp;company’s unique platform is inherently flexible and intended to work &nbsp;with established medications, new formulations of medicines, as well as &nbsp;future innovations such as gene therapy.
<a href="https://ir.clearsidebio.com/news-releases/news-release-details/clearside-biomedical-announces-numerous-presentations-arvo-2020">Source</a>
Gene therapy

belzupacap saratalocan (bel-sar) (AU-011)

Diabetic macular edema

Diabetic retinopathy

RGX-314 uses an AAV8 vector that contains a gene that encodes for a &nbsp;monoclonal antibody fragment which binds to and neutralizes VEGF &nbsp;activity.
RGX-314 &nbsp;is being developed as a novel, one-time subretinal treatment that &nbsp;includes the NAV AAV8 vector containing a gene encoding for a monoclonal &nbsp;antibody fragment. The expressed protein is designed to neutralize &nbsp;vascular endothelial growth factor (VEGF) activity, modifying the &nbsp;pathway for formation of new leaky blood vessels and retinal fluid &nbsp;accumulation.
<a href="https://www.regenxbio.com/rgx-314/">Source</a>
Gene therapy

Clearside Biomedical

Company Details