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Clinical Trials | Jul/Aug '14

Ora: Helping Surgeons Navigate Clinical Research and Product Development

Knowing the business of ophthalmic practice—not just the clinical aspect—is becoming a more important component of practicing medicine as the health care landscape continues to evolve. We eye care professionals have faced many challenges in bringing products to market and conducting innovative clinical trials. However, with the help of an organization like Ora, a full-service ophthalmic clinical research and product development firm, we are better able to combat those challenges by becoming involved in the inner workings of every aspect of developing a product, from concept to market. Based on my experience, I think of Ora as the wizard behind the curtain who helps transform ideas into commercialized products.


If you talk to your peers who conduct clinical trial research, the chances are high that they have some involvement with Ora. The team is extremely approachable, and, if you are interested in becoming involved in clinical trials, it is beneficial to get to know them. I first met with Ora at one of the national ophthalmology meetings, and every year since then, we have sat down to discuss their opportunities and my ideas. Thanks in part to this communication, our relationship has evolved into a mutually beneficial partnership.


One of my research interests relates to cerebral spinal fluid (CSF) pressure in glaucoma patients, as I believe that the origin of glaucoma comes from the balance between intraocular pressure (IOP) and CSF pressure. When I presented this idea to Ora, they connected me with companies that focus on noninvasive IOP monitoring. When we take a patient’s IOP measurement for 1 second, we think it is a representation of that patient’s IOP for the past year, but it is far from a complete picture of a patient’s IOP profile. New devices in development will allow us to get a much more complete picture of how a patient’s IOP is behaving at certain times, and there are surgical and nonsurgical devices that may potentially do this. Coupling the continuous IOP monitoring with our increased understanding of CSF pressure might help us find a breakthrough treatment for glaucoma. Ora’s introductions have been fruitful in helping me to pursue ideas, better understand my concepts, and potentially get a product to market.


As drug delivery becomes a more prominent part of how we practice ophthalmology, Ora has developed relationships with numerous companies that are interested in soliciting feedback from ophthalmologists to better understand our clinical needs, creating an opportunity to help companies get off the ground. Physicians are vital to the clinical aspect of creating a device or drug, and our involvement is key to the advancement of medicine; however, in order for a product to reach the market and thus our patients, industry connections are a must. As a result of my ongoing relationship with Ora, they contacted me to facilitate what could potentially turn into a clinical trial and advisement arrangement with a company producing medication for endothelial cell protection. As we perform more intraocular surgery for elective refractive reasons, the opportunity to protect endothelial cells makes a real difference in the postoperative outcomes of patients undergoing corneal transplantation, cataract surgery, or phakic IOL implantation.


The main challenge for ophthalmologists attempting to conduct research on their own is it is similar to building a plane while flying it. We can’t anticipate the unique challenges that go along with conducting clinical trials or bringing an idea to fruition. Ora’s network of ophthalmic experts and R&D professionals has a tight grasp on the intricacies of clinical trials that may be difficult for us to understand. Having access to a knowledgeable, experienced resource is imperative to successfully navigating clinical research. Ora’s preclinical and clinical models, unique methodologies, and regulatory strategies have helped facilitate 37 FDA approvals in the areas of allergy, allergic rhinitis, dry eye, retina, anti-infective and anti-inflammatory agents, glaucoma, drug delivery, and devices. Conducting clinical trials can be an overwhelming undertaking for eye care professionals, yet Ora has found a way to make the process smoother and more efficient.

John Berdahl, MD

John Berdahl, MD, is an Assistant Professor of Ophthalmology at the University of South Dakota and in practice at Vance Thompson Vision in Sioux Falls, South Dakota. He may be reached at john.berdahl@vancethompsonvision.com.