As Clearside prepares to transition from a clinical-stage to a commercial-stage company, Mr. Rodríguez will be responsible for ensuring that the company continues to design and implement appropriate programs, policies and procedures related to quality assurance and quality control activities across the company and its suppliers. He will also provide cross-functional compliance oversight of activities involving all recognized quality standards for the pharmaceutical industry, such as good manufacturing practices and good clinical practices.
Mr. Rodríguez is an accomplished quality management professional with over 30 years of experience in the pharmaceuticals industry. Before joining Clearside, Mr. Rodríguez was Vice President of Quality for Pharma Tech Industries, the world’s largest pharmaceutical contract manufacturer and packager of powder products. Mr. Rodríguez’s earlier experience includes quality and manufacturing leadership roles at various pharmaceutical companies, including Ciba Vision, Novartis Ophthalmics and Shionogi, Inc.
“Lester is a seasoned quality leader who brings to Clearside a wealth of experience and expertise in pharmaceutical quality assurance, quality control, and quality systems management,” said Clearside’s Chief Executive Officer and President, Daniel H. White. “As we plan for the potential commercial launch of our first product, and continue to develop our pipeline of advanced and pre-clinical product candidates, it is important that both Clearside and our suppliers continue to do everything we can to ensure strict quality control and regulatory compliance in our operations. We are pleased to have attracted a quality management professional of Lester’s caliber to this key position.”
Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases. Clearside’s proprietary suprachoroidal treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The company’s unique platform for eye disease treatments is inherently flexible and intended to work with established medicines, new formulations of medicines, as well as future innovations. Clearside’s pipeline includes advanced and pre-clinical product candidates in diseases where macular edema is a common complication, including uveitis, retinal vein occlusion (“RVO”) and diabetic macular edema (“DME”). Clearside’s most advanced program is in non-infectious uveitis and it expects to submit a New Drug Application to the U.S. Food and Drug Administration for use of suprachoroidal CLS-TA for the treatment of macular edema associated with non-infectious uveitis by the end of 2018. The company is also conducting two ongoing Phase 3 trials of suprachoroidal CLS-TA with an intravitreal anti-VEGF agent in patients with RVO. In addition, Clearside recently announced positive topline results from a Phase 2 clinical trial of suprachoroidal CLS-TA used with EYLEA® (aflibercept) in patients with DME, and is continuing to analyze additional data from the trial as it becomes available. Clearside is headquartered in Alpharetta, GA. For more information, please visit http://www.clearsidebio.com. Follow @clearsidebio on Twitter and Linkedin.
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 clinical development of Clearside’s product candidates, the timing of a potential submission of an NDA with the FDA, and the potential commercialization of CLS-TA and transition from a clinical-stage to commercial-stage company. 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, 2017, filed with the U.S. Securities and Exchange Commission(“SEC”) on March 16, 2018, 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.