Clearside Biomedical announced Arctic Vision has acquired an exclusive license for the commercialization and development of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.
XIPERE is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for suprachoroidal administration via Clearside’s proprietary SCS Microinjector™ that is being investigated as a targeted treatment of macular edema associated with uveitis.
“This licensing agreement further enables Clearside to expand the commercial opportunity for XIPERE in an attractive geographic market,” said George Lasezkay, Pharm.D., J.D., President and CEO, Clearside Biomedical. “We look forward to collaborating with Arctic Vision’s seasoned team of ophthalmic industry veterans who have substantial global experience at leading eye care companies, including Allergan, and expertise in launching eye care products in China, such as OZURDEX® (dexamethasone intravitreal implant). With strong resources and backing by top-tier global biotech venture capital investor, Pivotal bioVenture Partners, we believe Arctic Vision will be an effective strategic partner in helping to drive the expansion of XIPERE, if approved, in this important market.”
“We are excited to enter into this partnership with Clearside and we look forward to working together to bring this novel therapy to patients and healthcare providers in Greater China and South Korea,” said Eddy (Hoi Ti) Wu, Ph.D., Founder and CEO, Arctic Vision. “Due to the lack of satisfactory treatment with optimal efficacy and safety in our region, patients living with uveitis are in great need of an innovative approach. By potentially bringing meaningful benefit to these patients, XIPERE is an excellent addition to our growing portfolio of breakthrough treatments as we strive to lead the China ophthalmology market.”
Under the terms of the agreement, Clearside may receive up to a total of $35.5 million in development and sales milestones. This amount includes a $4.0 million upfront payment plus additional milestone payments for the achievement of specified events prior to and including receipt of approval of XIPERE in the United States. Clearside also will be entitled to receive tiered royalties of 10% to 12% based on annual net sales of XIPERE in Greater China and South Korea. Arctic Vision may pursue development and commercialization of XIPERE for additional ophthalmic indications in Greater China and South Korea, with consent from Clearside.
XIPERE™ (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 (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.