EyeKor
An Imaging Company for Ophthalmic Clinical Trials
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EyeKor, Inc., Announces Partnership with Ophthalmic Photographer's Society to Develop Clinical Trial Imaging Certification

EyeKor's partnership with the OPS aims to accelerate the startup process of pharmaceutical sponsored ophthalmic clinical trials and provide ongoing support for those trials in terms of the necessary imaging certification requirements.

MADISON, Wis. (PRWEB) November 03, 2017 -- EyeKor, Inc., announced today that it will collaborate with the Ophthalmic Photographers’ Society (OPS) to develop a Clinical Trial Imaging Certification Program for OPS members who are Certified Retinal Angiographers or Certified Optical Coherence Tomographers. This program aims to accelerate the startup process of pharmaceutical-sponsored ophthalmic clinical trials and provide ongoing support for those trials in terms of the necessary imaging certification requirements.

The use of Certified Clinical Trial Imaging professionals will greatly improve the quality of the specialized imaging required for ophthalmic clinical studies. Specifically, certified imaging professionals will be able to provide a more accurate evaluation of ophthalmic images, thereby enabling earlier evaluation of the data required for the determination of therapeutic success.

EyeKor is a Software-as-a-Service (SaaS) company providing image and data management solutions for ophthalmic clinical trials. As part of the collaboration, certified OPS photographers will use EXCELSIOR™, EyeKor’s 510(k)-cleared, cloud-based software platform, for both clinical and preclinical applications. The software platform will enable pharmaceutical sponsors and their contract research organization (CRO) partners to manage the ocular images and other data collected during their ophthalmic clinical trials and nonclinical studies, enhancing the efficiency and accuracy of data collection and interpretation. EXCELSIOR also allows leading scientists, principal investigators, CRO representatives, data managers, and reading center graders to access and track data in real time.

“We are very pleased to support our ophthalmic photographer partners in this way,” said Christopher J. Murphy, DVM, PhD, DACVO, and CEO of EyeKor. “Our collaboration is an important step for EyeKor in connecting the quality of imaging provided by the ophthalmic photographers with our sponsors, who bring ophthalmic therapeutics into the marketplace to benefit patients suffering from serious ocular diseases. We look forward to continuing our successful relationship.”

About the Ophthalmic Photographers Society: The Ophthalmic Photographers’ Society is a nonprofit organization dedicated to a highly specialized form of medical photography in the field of ophthalmology. The main objectives of the Society are to provide primary and continuing education in the field of ophthalmic photography, to set and maintain standards for the profession through multiple certification programs, and to promote scientific advancement in ophthalmic imaging technology. Members of the Ophthalmic Photographers' Society perform imaging of all structures of the eye using highly specialized equipment to increase the level of patient care and help to advance the science and practice of ophthalmology.

About EyeKor: 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 through 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 the FDA as a Class II medical device, with specific indication for use for managing ophthalmic clinical trials.

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Yijun HuangComment
The Advantages of Using OCT in Ophthalmic Preclinical Studies

Optical coherence tomography (OCT) is an ophthalmic imaging technology that provides a cross sectional view of multiple ocular structures at near-cellular resolution.

The retina, vitreo-retinal interface, optic nerve, and portions of the choroid can all be examined in fine detail. Anterior segment OCT allows visualization of distinct corneal layers and structures in the iridocorneal angle. These capabilities make OCT a valuable imaging tool for diagnosing ocular diseases in the clinic, assessing the efficacy of treatments, and for evaluating the pharmacological and toxicological effects of drugs during clinical trials and in preclinical research.

As a research and clinical tool, OCT provides quantitative thickness and volumetric values for the central retina and is useful in the clinical diagnosis and longitudinal monitoring of various retinal lesions including macular edema, macular hole, and geographic atrophy. The quantitative nature of the measurement provides valuable biomarkers for investigating retinal diseases such as diabetic retinopathy, glaucoma, age-related macular degeneration and other hereditary retinal degenerations like retinitis pigmentosa.

While OCT is just one of many imaging technologies available to researchers, it offers some unique advantages, particularly during the preclinical phase of development.

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Yijun HuangComment
The 6 Phases of Ophthalmic Preclinical Research

The outcome of a clinical research program depends, in no-small part, on the decisions made during the preclinical phases of development. As with virtually all fields of pharmaceutical research, the goal of the ophthalmic preclinical process is to identify and elevate a lead candidate to advance into the next phases of research, or to eliminate a candidate in the research stage as early as possible to optimize R&D resources and efforts.

Since animal models can reproduce important pathologic aspects of human ocular diseases, they’re used in preclinical research to determine the efficacy of the novel therapies.

Those developing such therapies, however, should be well aware of important limitations associated with animal models. While it’s possible to model some parts of a human disease in a non-human species, many ophthalmic conditions – particularly those affecting the posterior segment – could present challenges for researchers.

To meet these challenges, EyeKor’s EXCELSIOR™ Preclinical platform gives researchers more power to see valuable results from their preclinical data. To set the stage for how these new systems can help, let’s briefly step back and run through each phase of the ophthalmic preclinical process step-by-step.

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EyeKor EXCELSIOR™ Platform Improves Efficiency in Ocular Preclinical Research

Working in partnership with the renowned experts at Ocular Services On Demand LLC. (OSOD), EyeKor is excited to continue introducing its cloud-based preclinical platforms to the ocular preclinical research community. The EXCELSIOR™ Preclinical platform is designed to bridge the gap between the laboratory and the clinic, bringing a powerful array of comparative vision science and ophthalmic imaging services to those developing exciting new treatments.

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Yijun HuangComment
Implications for Ophthalmology of the Just-released FDA Draft Guidance on Imaging in Clinical Trials

The evolution of diagnostic imaging technologies across medicine has been rapid, and a number of companies seeking approval for novel drugs and devices have been using and want to use imaging data as study endpoints in clinical trials. To assist these companies, the U.S. Food and Drug Administration (FDA) recently released a new draft guidance on the use of images in clinical trials. The new draft document, “Clinical Trial imaging endpoint process standards: Guidance for industry,” if enacted as written, will have important implications for the conduct of ophthalmic clinical trials.

Designed to provide a clear path for clinical trial sponsors who want to use images as an endpoint in drug and device clinical trials, the guidance focuses on creating standards for image acquisition, display, archiving, and interpretation, all of which the FDA considers key elements when imaging is used in determining whether a drug or device has met its primary endpoint.

Imaging process standards aim to help trial sponsors ensure that images are obtained in a uniform manner that complies with a trial’s protocol and that allows fair comparison with images obtained with different devices by different people and at different centers; the guidance also calls for a verifiable audit trail to document the accuracy and reliability of the imaging process. Uniformity in image gathering, transmission, and interpretation is a critical aspect of ensuring a clinical trial’s ability to establish treatment effects and detect potential safety concerns.

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Yijun HuangComment