31 March 2017
ALPHARETTA, Ga. and MADISON, Wis., March 31, 2017 (GLOBE NEWSWIRE) -- Clearside Biomedical Inc. (Nasdaq:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, announced today that it has entered into a strategic collaboration with EyeKor Inc. to support Clearside’s ophthalmic clinical trial activities.
Clearside is currently conducting Phase 3 clinical trials of suprachoroidally administered CLS-TA (“suprachoroidal CLS-TA”), its proprietary suspension formulation of the corticosteroid triamcinolone acetonide, in patients with macular edema associated with non-infectious uveitis, as well as suprachoroidal CLS-TA used concomitantly with intravitreally administered EYLEA® (aflibercept) (“intravitreal Eylea”) in patients with macular edema associated with retinal vein occlusion (“RVO”). In addition, Clearside has a clinical program in diabetic macular edema.
EyeKor is a Software-as-a-Service (SaaS) company providing image and data management solutions for ophthalmic clinical trials. As part of the collaboration, Clearside will use ExcelsiorTM, EyeKor’s 510(k)-cleared, cloud-based software platform, for both clinical and preclinical applications. The software platform will enable Clearside and its contract research organization (“CRO”) partners to manage the ocular images and other data collected during its ophthalmic clinical trials and nonclinical studies, enhancing the efficiency and accuracy of data collection and potential interpretation. It will also allow leading scientists, principal investigators, CRO representatives, data managers and reading center graders to access and track data in real time.
“EyeKor did an outstanding job in our two completed Phase 2 trials in uveitis and in RVO, and is continuing to support our clinical research programs,” said Daniel White, President and CEO of Clearside. “The level of service and the prompt and thoughtful nature of their assistance, coupled with the powerful and efficient Excelsior™ platform, is not just greatly appreciated, but also highly valued. EyeKor has been a great partner for us and we are looking forward to solidifying our collaboration and to further extending our success in ophthalmology clinical and preclinical programs.”
“We are very pleased to support our partner Clearside, a company solely focused on ophthalmic drug development,” said Christopher J. Murphy, DVM, PhD., DACVO, CEO of EyeKor. “Our strategic collaboration is an important step for EyeKor to validate the great power of our Excelsior™ application by assisting Clearside in bringing its ophthalmic therapeutics into the marketplace to benefit patients suffering from serious back-of-the-eye diseases. We look forward to continuing our successful relationship with Clearside.”
Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is a late-stage clinical ophthalmic biopharmaceutical company that envisions a world without blindness. Clearside relentlessly pursues transformative, elegant, precise solutions to restore and preserve vision. Clearside is developing advanced clinical and pre-clinical candidates using a proprietary treatment approach offering unprecedented access to the back of the eye through the suprachoroidal space (SCS™). This offers potentially meaningful treatment benefit to patients suffering from sight threatening diseases like uveitis, RVO, DME and wet AMD. To learn more about how Clearside is changing ophthalmology, please visit us at www.clearsidebio.com.
EyeKor, Inc. is a Software-as-a-Service (SaaS) company that offers a complete spectrum of integrated ophthalmic clinical trial image data management and analysis services, from preclinical to clinical phases I-IV. EyeKor expertise encompasses a diverse array of ophthalmic testing methods including fundus photography and angiography, optical coherence tomography, fundus autofluorescence imaging, automated visual field testing, and electrophysiological testing. EyeKor’s cloud-based software application, EXCELSIOR™, was built specifically for supporting image data collection and management of ophthalmic preclinical studies and clinical trials. EXCELSIOR™ utilizes the latest web and imaging technologies for data standardization, analysis, grading and reporting. EXCELSIOR™ is cleared with FDA as a class II medical device, with specific indication for use for managing ophthalmic clinical trials.
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, and the potential market for, Clearside’s product candidates. 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, 2016, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 16, 2017 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.
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