Clearside Biomedical Expands Patent Portfolio in the U.S. and Europe

Clearside Biomedical announced the recent issuance of three additional patents in the United States and Europe.

The United States Patent and Trademark Office (USPTO) recently granted patent number 10,722,396 to Clearside.  This patent covers Clearside’s SCS Microinjector® for the suprachoroidal administration of axitinib (CLS-AX) and expires in 2034.

The European Patent Office (EPO) issued two patents in the largest European markets. Patent number 2,563,429 expires in 2031 and covers a device for the suprachoroidal administration of any therapeutic agent. Patent number 2,916,827 expires in 2033 and covers the use of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) and the treatment of uveitis and other posterior ocular diseases with triamcinolone acetonide.

Clearside’s 21 granted U.S. patents and its 20 granted European patents provide extensive coverage of the SCS Microinjector device, the use of the device, administration of any drug into the suprachoroidal space by injection, as well as specific product candidates.

“Clearside is the market leader in suprachoroidal delivery, and the issuance of these patents in two of the largest world markets significantly strengthens the IP portfolio governing our proprietary SCS Microinjector and our product candidates,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “We are committed to broadening our global patent estate as we continue to expand our internal pipeline and increase patient access to innovative therapies. We look forward to achieving additional milestones by the end of 2020 as we and our partners expect to have three product candidates delivered via our SCS Microinjector in four clinical trials.”

Clearside’s patented, proprietary suprachoroidal space (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 such as gene therapy.

CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. 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. Clearside believes 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. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and an exclusive option for Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health’s affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.