ALPHARETTA, Ga., Oct. 25, 2018 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc.(NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced the appointment of Thomas A. Ciulla, M.D., M.B.A. to the position of Chief Medical Officer.
A board certified ophthalmologist and retinal specialist, Dr. Ciulla brings over 27 years of clinical practice, academic and executive management experience within the global ophthalmic industry to Clearside. Prior to joining Clearside, Dr. Ciulla served as Vice President, Ophthalmic Strategy Lead at Spark Therapeutics, Inc. In that role, among other accomplishments, he defined and led medical strategy to support development and commercialization of Luxturna (voretigene neparvovec-rzyl), the first U.S. Food and Drug Administration (“FDA”)-approved gene therapy for a genetic disease.
Before launching his executive management career, Dr. Ciulla co-directed the retina service and ocular angiogenesis research laboratory at Indiana University School of Medicine, the largest U.S. medical school. Today, he remains a volunteer Clinical Professor of Ophthalmology at the university and also serves on the Board of Directors of Midwest Eye Institute. Dr. Ciulla is an active member of the Association for Research in Vision and Ophthalmology, Macula and Retina Societies, American Society of Retina Specialists, and the American Academy of Ophthalmology.
Dr. Ciulla has held numerous leadership roles in clinical research, including principal investigator, medical monitor, and member of scientific advisory, data safety monitoring or writing committees in over 100 national clinical trials, including CATT and registration trials for nearly all retinal therapeutics currently approved by the FDA. He has served on journal editorial boards, edited several textbooks, presented at over 200 conferences, and co-authored over 200 publications, including the first published U.S.-based randomized clinical trial on any intravitreal therapy in neovascular AMD. Dr. Ciulla graduated from Harvard College and UCSF Medical School, followed by an internship and residency at Harvard Medical School, and a fellowship at Tufts Medical School. He also earned an MBA from Indiana University’s Kelley School of Business, specializing in the business of medicine.
“In addition to being a skilled ophthalmologist and retinal specialist, Tom is well recognized for his ability to serve as a strong liaison between ophthalmic biopharmaceutical developers and their stakeholders, as well as for his passionate commitment to ensuring clinical programs are designed to meet the needs of both clinicians and patients,” said Clearside’s Chief Executive Officer and President, Daniel White. “I have great confidence that he will play a key role in the continued advancement of both our late-stage pipeline and our non-clinical programs in areas such as gene therapy and choroidal drug delivery.”
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 FDA for use of XIPERE™ (formerly “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 XIPERE 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 XIPERE 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.
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, and the timing of a potential submission of an NDA with the FDA. 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.