Industry Insider is a timely chat with an ophthalmic industry thought leader.

Robert J. Dempsey was appointed as CEO of TearClear in April. TearClear is developing a platform that can deliver preservative-free eyedrops to the ocular surface. Mr. Dempsey has spent more than 20 years in the ophthalmic pharmaceutical industry and previously served as the global head of ophthalmology at Shire.

Ophthalmology Management: What can you tell us about TearClear’s preservative-free topical technology?

Robert Dempsey: Each year, there are about 36 million prescriptions written to treat glaucoma with topically administered drops, the majority of which contain a preservative such as benzalkonium chloride (BAK). A 2013 study by Rouland et al shows that BAK may contribute significantly to the ocular toxicity and inflammation associated with the chronic use of glaucoma medications.

At TearClear, we want to safely contain these medications in a bottle, but also capture that preservative before it hits the ocular surface so the only thing the patient is receiving is the medicine. We accomplish that through a novel approach in which we capture BAK as it enters the tip of the bottle, keeping it from the eye.

This delivery method is versatile, as well. In our pipeline we have more than 10 programs to treat multiple disease states. Glaucoma will pave the way for other programs in development.

OM: Why focus on glaucoma at first?

RD: When you look at the literature surrounding glaucoma treatments, you see that about 30% of patients have a reaction to BAK, which can lead to moderate to severe symptoms of ocular surface disease. Giving those patients a preservative-free topical treatment will be our immediate focus.

In addition, we are currently in the process of building a pharmaceutical company that can disrupt the way topical medication is delivered to the ocular surface. Because of that, glaucoma was an inviting space for us as it is a large U.S. market and worth approximately $4 billion.

OM: You have spent more than two decades in the ophthalmic pharmaceutical industry. How has that prepared you for leading TearClear?

RD: My diverse experiences have positioned me to be CEO of TearClear. When I think of my background, starting in sales, to sales management, to leadership positions, having a deep understanding/appreciation of development — those verticals allowed me to seamlessly assume this position.

As CEO, you’re responsible for all these critical areas of building the business; at the end of the day, you have to understand the clinical development pathway. Working with the FDA and other regulatory agencies is critical, and once you know how that works you can build a business plan, development plan and medical plan.

OM: What are your goals for TearClear?

RD: First, I want to prepare a successful launch for the company into the ophthalmic space and ensure the viability of that program.

In 2021, we will conduct multiple registration studies in the United States and submit them to the FDA for approval, with the plan to advance additional pipeline programs of our preservative-free delivery program in 2022. Our goal is to build and execute the commercial plan in preparation for launch over the next two years.

As a final thought, we have a first-in-class versatile platform. TearClear’s immediate focus is the 30% of glaucoma patients on chronic medications who are experiencing moderate to severe DED symptoms. If we can capture these preservatives before they reach the ocular surface, we can enhance both patient safety and compliance. OM