ECS07
DEVELOPMENT OF A NOVEL GORE SYNTHETIC CORNEA DEVICE
A. Singh1,*
1W. L. Gore & Associates, Elkton, United States
W.L. Gore & Associates is a material science company and a leading developer of successful medical devices with applications in cardiovascular and general surgery. Through our unique material technologies, we provide differentiated solutions to clinically critical unmet needs. Tasked with identifying new growth areas, we are investigating the value of our materials and medical device capabilities in Ophthalmology. Today, we are actively partnering with ophthalmologists to understand their unmet needs and to solve these problems with our materials technology, understanding of tissue-materials interfaces, device design and product development know-how.
Over the past eight years, we have engaged with hundreds of ophthalmologists to better understand the challenges they face. A significant challenge we have identified is in the treatment of corneal blindness. Diseases affecting the cornea are the third leading cause of blindness worldwide, following cataract and glaucoma, affecting about 7-9 million people globally. Currently, there are no medical treatments available to restore clarity in diseased corneas. Donor transplantation remains the mainstay of management. In countries where there is an inadequate supply of donor tissue or in patients who are unable to maintain corneal clarity, the only option to restore vision is through the use of a synthetic cornea.
To address this challenge, we have applied our materials expertise to develop a synthetic cornea device prototype that can potentially restore vision without the limitations of the current treatment options. The results of a recently concluded pre-clinical study attest to the favorable outcomes observed with our prototype device and materials of construction. Currently, we are preparing to initiate a first-in-human study in Q1 2024 to evaluate the initial safety and effectiveness of our device prototype in the treatment of corneal opacity in patients who are candidates for corneal surgery.