Arctic Vision Congratulates Clearside Biomedical on U.S. FDA NDA Filing Acceptance for XIPERE™ (Triamcinolone Acetonide Suprachoroidal Injectable Suspension)
2021-06-03

SHANGHAI, China, June 3, 2021 -- Arctic Vision today congratulates its collaboration partner Clearside Biomedical, Inc. (Nasdaq: CLSD) on the U.S. FDA acceptance of their resubmitted New Drug Application (NDA) for XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of macular edema associated with uveitis. In March 2020, Arctic Vision acquired an exclusive license from Clearside for the development and commercialization of XIPERE in Greater China (mainland China, Hong Kong, Macau, and Taiwan) and South Korea. Arctic Vision’s project code for XIPERE is ARVN001.


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Dr. Eddy (Hoi Ti) Wu, Founder, CEO and Board Director of Arctic Vision, commented, “Clearside’s novel and proprietary suprachoroidal space (SCS®) injection platform has the potential to deliver therapeutic benefits for patients globally. We are delighted with the achievement of this major regulatory milestone for XIPERE and would like to congratulate the Clearside team for the progress they have made. As the first asset established within Arctic Vision, we are confident of ARVN001’s further development in China and other Asian Regions, and are proud to be Clearside’s trusted partner as we continue our collaboration in the future.”

 

The acceptance of the XIPERE NDA resubmission is an important milestone for Clearside,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer of Clearside. “As the pioneers in treating back of the eye diseases through the suprachoroidal space, we believe our extensive clinical experience with XIPERE shows the potential for a reliable, non-surgical, office-based method for the treatment of a broad range of retinal diseases. We appreciate the continued support and progress by Arctic Vision, as we look towards the opportunity to improve the lives of patients suffering from macular edema associated with uveitis.”

 

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About XIPERE™ / ARVN001

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 suprachoroidal space that is being investigated 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. An affiliate of Bausch Health acquired the exclusive license for the commercialization and development of XIPERE in the United States and Canada in October 2019. The Bausch Health affiliate also has an exclusive option for commercialization and development of XIPERE in Europe and the United Kingdom, Australia and New Zealand, and/or South America and Mexico.

 

In March 2020, Arctic Vision acquired the exclusive license for the development and commercialization of XIPERE in Greater China and South Korea. ARVN001 is Arctic Vision’s project code for the XIPERE asset. In December 2020, Arctic Vision obtained approval for its Investigational New Drug (IND) submission for an uveitic macular edema (UME) Phase III trial from the National Medical Products Administration (NMPA) in China.

 

XIPERE is not yet approved in any jurisdiction.

 

About Uveitic Macular Edema (UME)

Uveitis is a set of ocular inflammatory conditions and one of the major causes of visual morbidity.  Macular edema (ME) is a common complication in patients with uveitis, which is characterized by a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision. UME is the leading cause of vision loss and blindness in uveitis patients and can occur from uveitis affecting any anatomic location—anterior, intermediate, posterior or panuveitis.

 

About Arctic Vision

Arctic Vision is a China-based clinical stage specialty ophthalmology company with a leading portfolio of breakthrough technologies. The Company’s vision is to address unmet medical needs in ophthalmology with the discovery, development, and commercialization of innovative therapies in China, Asia and globally. Arctic Vision is led by an elite team of ophthalmic industry veterans with substantial and compelling R&D and commercial experience in both China and globally. For more information, please visit https://www.arcticvision.com.

 

Arctic Vision Media Contact

communications@arcticvision.com

 

Reference :

1.    Bausch Health And Clearside Biomedical Announce U.S. FDA Filing Acceptance For XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)

2.   Clearside Biomedical Announces Resubmission of New Drug Application for XIPERE™ for Treatment of Macular Edema Associated with Uveitis

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

4.   Arctic Vision obtains the first IND approval for the treatment of UME in China, Suprachoroidal space (SCS) injection potentially brings more benefits to patients

 


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