NDA Resubmission to the FDA Expected to Occur in the First Quarter of 2020
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. Clearside expects to resubmit its New Drug Application (NDA) for XIPERE to the
"
"We believe that partnering with Bausch + Lomb will allow us to maximize XIPERE's commercial potential and provide broad accessibility for patients," said George Lasezkay, Pharm.D., J.D., CEO of Clearside. "With an established and experienced ophthalmic sales force, we believe Bausch + Lomb can quickly and efficiently integrate XIPERE into their commercial operations. We look forward to coordinating with the Bausch + Lomb team to gain regulatory approval and to share key learnings from our physician training program to help ensure a successful launch of XIPERE in
Under the terms of the agreement, Clearside will receive up to
About XIPERE™
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 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.
About Clearside Biomedical
About Bausch + Lomb
Bausch + Lomb, a
About Bausch Health
Clearside 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 the timing for resubmitting the XIPERE NDA and the
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. Where applicable, these statements are based upon the current expectations and beliefs of