“Our SCS injection platform continues to be well-received by the medical community,” stated
Gene Therapy Presentations:
Summary: At the
Viral Kansara, Ph.D., Clearside Vice President, Discovery, presented a poster entitled, “Suprachoroidally delivered non-viral DNA nanoparticles transfect chorioretinal cells in non-human primates and rabbits.” The poster stated that suprachoroidally injected DNA nanoparticles (DNPs) were well tolerated, with luciferase expression/activity in the choroid and retina of rabbit eyes. Most importantly, suprachoroidal administration of luciferase non-viral DNPs produced activity that was comparable to that seen from subretinal injections. In non-human primates, the persistence of luciferase activity was observed through day 22 (last study timepoint) with ellipsoid-shaped DNPs. These studies support further evaluation of suprachoroidally administered non-viral DNA nanoparticle gene therapy.
Summary: Ongoing assessment of the Clearside clinical programs for XIPERE continue to demonstrate the potential effectiveness of the agent to treat patients suffering from macular edema secondary to uveitis. Clearside submitted a New Drug Application to the
These presentations are available on Clearside’s website in the Science section under Programs (http://www.clearsidebio.com/programs.htm#SCIENCE).
About Suprachoroidal Space (SCS) Injection Platform
Clearside’s 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.
XIPERETM (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection, formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via suprachoroidal injection 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, thus potentially providing advantageous and sustained efficacy with a favorable safety profile. A New Drug Application was submitted to the
About Uveitis and Macular Edema
Uveitis is a set of ocular inflammatory conditions and is one of the leading causes of vision loss, affecting approximately 350,000 patients in the United States and more than one million worldwide. Approximately one-third of these patients develop uveitic macular edema, a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision. Macular edema 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 pan. The uveitis market is expected to grow by 2024 to nearly $550 million in the United States and over $1 billion globally.
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 expectations regarding the potential benefits of SCS injection platform, the potential attributes and benefits of Clearside’s product candidates and the potential approval and commercialization of XIPERE in