According to the company, a pair of presentations at the American Society of Retina Specialists annual meeting in Seattle highlight CLS-AX as a promising wet AMD treatment with a new mechanism of action and the potential for longer duration of effect than current therapies.
Clearside Biomedical Inc., in a pair of presentations at the American Society of Retinal Specialists annual meeting in Seattle, is highlighting drug delivery.
On Thursday, during the Ophthalmology Innovation Source (OIS) Retina Innovation Summit, a panel titled “Spotlight on Delivery” was moderated by Thomas A. Ciulla, MD, MBA, chief medical advisor at Clearside.
George Lasezkay, Pharm.D., JD, the company’s president and CEO, presented during that session, according to the news release.
According to the company, CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity.
Moreover, company officials noted in a news release that this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade 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 and in a Phase 1/2a wet AMD clinical trial in which CLS-AX was well tolerated and demonstrated an excellent safety profile. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers while limiting drug exposure to the front of the eye. Clearside is developing CLS-AX as a long-acting therapy for the treatment of retinal diseases.
On Sunday, Rahul N. Khurana, MD, FASRS, is presenting “Safety and Tolerability of Suprachoroidal Injection of CLS-AX in Neovascular AMD Patients With Persistent Activity After Anti-VEGF Therapy.”
SCS Injection Platform and SCS Microinjector
Clearside’s patent protected, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye, where sight-threatening disease often occurs. The company noted its platform “is inherently flexible and intended to work with established and new formulations of medications.”
According to the company, its patented SCS Microinjector can deliver a wide variety of drug candidates into the suprachoroidal space, providing targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells.
According to the news release, the SCS Microinjector system comprises a syringe, a custom-designed hub, and two 30-gauge hollow microneedles of varying lengths, each less than 1.2 millimeters, optimizing insertion and suprachoroidal administration of drugs.