“Clearside has a compelling opportunity to leverage our innovative, non-surgical suprachoroidal space (SCS) delivery platform to make a difference for patients with sight-threatening diseases in the U.S. and around the world,” said George Lasezkay, Pharm.D., J.D., Clearside’s Interim Chief Executive Officer. “We believe our proprietary approach and strong intellectual property in the suprachoroidal space are broadly applicable across a range of serious ophthalmic diseases.”
Dr. Lasezkay continued, “We are validating our platform with the potential approval of our first product candidate, XIPERE™ (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection for the treatment of macular edema associated with uveitis, a condition that currently has no approved therapies. Uveitis is a leading cause of vision impairment and blindness in the developed world, and treating the associated macular edema is particularly important as it is an underserved patient population often affecting younger people and can result in numerous years of lost visual function.”
“We have a highly experienced team that developed XIPERE, submitted our New Drug Application (NDA) to the
- Clearside’s NDA for XIPERE for the treatment of macular edema associated with uveitis was accepted for review by the
FDAand assigned a PDUFA (Prescription Drug User Fee Act) goal date of October 19, 2019.
- Biopharmaceutical executive and current Clearside Board member, George Lasezkay, Pharm.D., J.D., was appointed to the position of Interim Chief Executive Officer.
- Use of Clearside’s SCS injection platform in uveitis patients and with gene therapy was highlighted at the
Association for Research in Vision and Ophthalmology(ARVO) 2019 Conference.
- Clearside’s SCS injection platform was featured at the 42nd Annual Meeting of
The Macula Societyin multiple oral presentations, including release of new, non-clinical data on suprachoroidal administration of gene-based therapies.
First Quarter 2019 Financial Results
Clearside’s research and development expenses for the quarter ended
General and administrative expenses were
Net loss for the quarter ended
Cash, cash equivalents and short-term investments totaled
About Clearside’s 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.
XIPERE™ (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 non-surgically 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 to minimize side effects and harm to the surrounding healthy parts of the eye, thus potentially providing advantageous and sustained efficacy with a favorable safety profile. An NDA was submitted to the
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 the SCS injection platform and the potential approval and commercialization of XIPERE for the treatment of macular edema associated with uveitis. 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, 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.