Clearside Biomedical Announces Leadership Team Update
Clearside Biomedical, Inc. (NASDAQ:CLSD) announced the transition of Chief Medical Officer Thomas A. Ciulla, M.D., M.B.A., to Chief Medical Advisor-Retina, effective February 17, 2023. Dr. Ciulla will continue to provide expertise as chair of the Scientific Advisory Board and support the ODYSSEY Phase 2b clinical trial. CEO George Lasezkay highlighted Dr. Ciulla's contributions to the company’s success, particularly in advancing their suprachoroidal delivery platform. The clinical team, led by Chief Clinical Officer Dr. Susan Coultas, is prepared to initiate the ODYSSEY trial, showcasing Clearside's commitment to innovative eye therapies.
- Tom Ciulla's new role enhances strategic advisory support for ongoing clinical trials.
- Dr. Susan Coultas brings extensive experience to oversee upcoming clinical trials.
- Transition of a key executive may disrupt continuity in leadership.
- Potential challenges in maintaining momentum in ongoing clinical trials.
ALPHARETTA, Ga., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today announced that its Chief Medical Officer and Chief Development Officer, Thomas A. Ciulla, M.D., M.B.A., will transition to the role of Chief Medical Advisor-Retina for Clearside and step down from his full-time position, effective February 17, 2023. In his new advisory capacity, Dr. Ciulla will chair the Company’s Scientific Advisory Board (SAB), sharing his medical expertise as a practicing retinal specialist and providing counsel on Clearside’s ODYSSEY Phase 2b clinical trial and other suprachoroidal development programs.
George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer, commented, “As a leading industry expert regarding suprachoroidal delivery, Tom has been an integral part of our team as we achieved approval for our first commercial suprachoroidal product, XIPERE®, and successfully advanced our lead development asset, CLS-AX, into our Phase 2b ODYSSEY trial in wet AMD. We thank Tom for his many contributions to Clearside. His belief in, and dedication to demonstrating, the potential of administering therapeutics into the SCS has been outstanding. We look forward to his continuing relationship with Clearside by providing ongoing advice and guidance as our Chief Medical Advisor-Retina and Chairman of our SAB. It has been my personal and professional privilege to work with Tom for the last four years and I want to wish him all the very best as he begins a new endeavor.”
“Under Tom’s leadership, our Phase 2b ODYSSEY protocol was designed and is now in place, and our clinical team, led by our Chief Clinical Officer, Dr. Susan Coultas, is prepared to initiate the trial in the first quarter of this year. With overall operational responsibility for conduct and execution of the study, Susan’s prior experience in advancing ophthalmic therapies from the early clinical development stages through final approval for commercialization is an important and valuable asset for us at this stage,” concluded Dr. Lasezkay.
“It has been a rewarding experience for me to work at Clearside as its Chief Medical Officer and Chief Development Officer, and I am proud of my time serving on the Clearside management team. Now, as its Chief Medical Advisor-Retina and Chair of its SAB, I look forward to continuing to provide advisory support to the Company’s ODYSSEY clinical trial and to other innovative programs targeting the suprachoroidal space with Clearside’s proprietary SCS delivery platform. The ODYSSEY clinical trial is well designed to show potential 6-month durability and maintenance of visual acuity that CLS-AX may provide for wet AMD patients. Since joining Clearside last summer, Susan has utilized her extensive industry experience in clinical development operations to progress CLS-AX into later stage development and ensure a successful initiation and execution of the ODYSSEY trial. I will be excited to follow the progress of ODYSSEY in my advisory role with Clearside,” said Thomas A. Ciulla, M.D., M.B.A.
Susan Coultas, Ph.D., Chief Clinical Officer
Dr. Coultas joined Clearside as the Company’s Chief Clinical Officer in June 2022, bringing 35 years of experience in clinical development in the biopharmaceutical industry. As Chief Clinical Officer, she is responsible for clinical operational planning and management oversight of the initiation and execution of all Clearside clinical trials as well as interactions with the FDA and international health authorities regarding all clinical trials. Prior to Clearside, Dr. Coultas served as Senior Vice President of Clinical Development at Kala Pharmaceuticals, where she was responsible for the planning and execution of its clinical programs, resulting in two new drug application filings and product approvals. Dr. Coultas has worked with multiple ophthalmic companies, both internally and as a consultant, including Alcon Laboratories, Inc., CibaVision Ophthalmics, Sucampo Pharmaceuticals, and Bausch+Lomb, Inc. Earlier in her career, as owner of InfoQuest Clinical Network, Inc., Dr. Coultas successfully identified, developed, and led a large network of clinical research professionals that managed numerous clinical trials in multiple systemic and ophthalmic therapeutic areas. Dr. Coultas earned a Ph.D. in Public Health, Epidemiology, from Walden University, a M.S. in Biology from University of North Texas, and a B.S. in Biology from Texas Wesleyan University.
About Clearside Biomedical
Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Clearside’s SCS injection platform, utilizing the Company’s proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector and strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. Clearside’s first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, is commercially available in the U.S. For more information, please visit 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 statements regarding the clinical development of Clearside’s product candidates, including CLS-AX, and Dr. Ciulla’s and Dr. Coultas’s future contributions to the 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, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the U.S. Securities and Exchange Commission (SEC) on March 11, 2022, Clearside’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2022 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.
Investor and Media Contacts:
Jenny Kobin
Remy Bernarda
ir@clearsidebio.com
(678) 430-8206
Source: Clearside Biomedical, Inc.
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