Jul 31, 2020

Clearside Biomedical Announces License Agreement with Arctic Vision for XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) in Greater China and South Korea

2020-03-11

– Arctic Vision to Lead Expansion of Novel Approach to Treating Macular Edema Associated with Uveitis in Asia –

– Clearside Eligible to Receive Upfront and Milestone Payments and Royalties on Product Sales –

– Increasing Global Awareness of Innovative Suprachoroidal Injection Platform –

ALPHARETTA, Ga. and SHANGHAI, China, March 11, 2020 — Clearside Biomedical, Inc. (Nasdaq:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Arctic Vision, a  company focused on developing and commercializing innovative ophthalmology therapies in China and Asia, 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.

About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)

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.

About Clearside Biomedical

Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

About Arctic Vision

Arctic Vision is a leading specialty ophthalmology company in China with a portfolio of breakthrough technologies. The Company is led by an elite team of ophthalmic industry veterans with substantial and successful China and global experiences in R&D and commercialization of eye care products. Arctic Vision has top-tier biotech venture capital investors with a broad network in both China and the U.S./European ophthalmic markets, in-depth knowledge and an unprecedented track record in company incubation in China. For more information, please visit www.arcticvision.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding XIPERE™’s commercial potential and Arctic Vision’s ability to successfully launch XIPERE™ in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 15, 2019, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 6, 2019, and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Clearside Investor and Media Contacts:

Jenny Kobin

Remy Bernarda

ir@clearsidebio.com

(678) 430-8206

Arctic Vision Media Contacts:
Wenxin Li
info@arcticvision.com
(21) 6850 3275