Clearside Biomedical products

Clearside’s proprietary SCS injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The company’s unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations, that can be delivered via suprachoroidal administration.

The suprachoroidal space is a potential space that traverses the circumference of the eye’s posterior region and lies internal to the sclera and external to the choroid. The innermost layer of the choroid, known as Bruch’s membrane, is compact. The outermost border is more a zone of transition, consisting of several lamellae with variable thickness. Because of its proximity to the choroid, drug delivery through the suprachoroidal space has the potential to reach the retina and the retinal pigment epithelium via the choroid.

CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal use. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. We believe this broad VEGF blockade may have efficacy advantages over existing retinal therapies and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. With CLS-AX, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. We are currently developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

We believe our platform offers the potential for safer, targeted ocular gene therapy without some of the risks of surgery and subretinal administration. Suprachoroidal administration of gene therapy could ultimately enhance access to care because it does not require specialized gene therapy surgery treatment centers. The procedure for suprachoroidal injection is conducted in an office setting and is similar in terms of patient preparation and duration to the procedure for intravitreal injection.  Therefore, we believe our products could be incorporated into retina specialists’ standard medical practice. We believe suprachoroidal administration may further enhance the value proposition of ocular gene therapy by potentially improving safety and expanding access.

As part of our small molecule program, we are evaluating the suprachoroidal administration of an integrin inhibitor suspension. Integrins play a role in pathologic processes, such as inflammation, angiogenesis and fibrosis. Suprachoroidal delivery of an integrin inhibitor suspension could provide targeting, compartmentalization and durability advantages over topical or intravitreal delivery, similar to what we have observed in other preclinical studies of small molecule suspensions, such as triamcinolone acetonide and axitinib.