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The Do’s and Don’ts of Developing Dry Eye Treatments

Bringing physicians together with entrepreneurs and industry can generate some clear insights.

Preeya Gupta, MD, of Duke University Eye Center, led a conversation called “Evolution of the Dry Eye Market” at October’s Ophthalmology Innovation Summit, held just prior to the annual meeting of the American Academy of Ophthalmology.

Here are five distinct takeaways delivered by the panel.

Develop for the Markets of Tomorrow

Before he was chairman of Oyster Point Pharmaceuticals, Michael Ackermann, PhD, worked with a team developing an implantable device. It looked promising, but it was expensive. The team decided to abandon the program, realizing that it was no longer realistic to think the device would receive a high- dollar CPT code to cover the cost of the procedure. “Where I think that’s really relevant today is that we need to remember we’re not developing for what the market is now, we’re developing for the market that we’re going to be launching into, and the market that we’re going to be competing in for years to come,” he said.

Innovation Begets Innovation

Caroline Blackie, OD, PhD, medical director, ocular surface disease at Johnson & Johnson Vision Care, said successful innovation can provide an opportunity to change the way medicine is practiced, to have a profound effect on patients’ lives. In a previous position at TearScience, she saw that there was a significant lack of clarity over not only why meibomian gland dysfunction should be seen as important, but even what it was. The company realized that it was extremely unlikely that doctors would physically manipulate the gland to evacuate stagnant content, for rehabilitation. So, the firm innovated a device that would perform that function. What no one expected was that because the technology worked, a number of other device treatments now exist with an add-on manual expression of the gland. “So the base point,” she maintained, “is that when you innovate something that truly works, you have the opportunity to change the face of medicine.”

Don’t Skimp on Your Supply Chain

Quinton Oswald, CEO of Notal Vision, added that for venture- backed companies, venture capitalists sometimes think that the chemistry, manufacturing, and controls phase can be done at the end. But that’s not the case, he said. A company should start early on with its supply chain because products can fail at the approval level due to lack of control. “Push very hard on your boards to allow you to invest in that specific area,” Oswald said.

Clinical Trial Design Is Key … and Complicated

Dr. Blackie stated that clinical trial design, whether for a diagnostic or therapeutic product candidate, comes down to knowing what you’re doing, why you’re doing it, and how to measure it. She said the “why” is usually to try to elevate and potentially transform the patient experience. But for the “what” and “how,” there needs to be extreme clarity about what component or components of the ocular surface system are to be affected and perturbed. “As we think about the dry eye patient and how we collect that patient, if we think about the system in general it becomes overwhelmingly complex,” Dr. Blackie continued. “We really need to titrate and drill down to what components of that system we’re looking to address so that we can home in on the appropriate metric.”

Headwinds Are Good

Christian Roesky, MD, PhD, managing director and CEO at Novaliq, said his group encountered resistance to its decision to try to redefine cyclosporine for dry eye disease. People didn’t believe its use could be improved after 10 years on the market, but eventually the treatment succeeded. “We need headwinds,” Dr. Roesky explained. “If we just follow trends, we will not explore something new.” Want to hear more? At the upcoming OIS meeting at SECO, clinical leaders will share their perspective on the latest developments in treating Dry Eye Disease, including predictions on where they see the market going.

The purpose of this exclusive half-day meeting is to showcase ophthalmic innovations under development for the optometric community. The meeting also create opportunities for clinicians and industry professionals to connect and exchange insights on the future of the sector.

This is a must-attend program for any practitioner interested in advancing their practice to the next level. The summit is being conveniently held at the Marriott New Orleans Downtown, across from the Convention Center. Register ASAP and block out your schedule for Thursday, February 21 from noon until 6:00 PM. Go to https://ois.net/ois-seco- 2019/register/ to register.

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