This month, we highlight Kala Pharmaceuticals, a biopharmaceutical company committed to advancing the treatment of eye diseases. I recently had the pleasure to speak with Kala’s Chairman, President, and CEO, Mark Iwicki.

MARK IWICKI
CHAIRMAN, PRESIDENT, & CEO, KALA PHARMACEUTICALS

Mr. Iwicki, please tell us about your company in terms of its history and direction.

Kala was started a little over 10 years ago through the work of two scientists—Hongming Chen, ScD, and Justin Hanes, PhD, who had worked in Dr. Robert Langer’s laboratory at Massachusetts Institute of Technology (MIT). Dr. Chen is now Kala’s chief scientific officer, and Dr. Hanes is the director of the Center for Nanomedicine and a professor of Ophthalmology at Johns Hopkins University.

Dr. Chen became Kala’s first employee and worked on what at that point was called mucus-penetrating particle technology—now branded as Ampplify drug delivery technology—that Dr. Hanes and Dr. Chen had developed at MIT and then patented. I joined the company just as early clinical data became available for the post-surgery product Inveltys and for the dry eye product Eysuvis a few months later. That was about six years ago; since then, those two products have been approved by the U.S. Food and Drug Administration and launched into the market.

Tell us about any new developments in which Kala is involved.

Before Eysuvis, there was no approved product with a clinical profile for the short-term treatment of dry eye disease, including flares. Our market research indicates that for as many as 80% of patients, the manifestation of their disease is the flares, a rapid onset of inflammation caused by a trigger, which typical patients suffer several times per year, rather than significant continual symptomatology. When we were finalizing the development of Eysuvis, there were maintenance products on the market or in development. Their onset of action is often weeks or months. If a patient is having an acute exacerbation or flare, those products will not likely help. And some patients who use maintenance products still experience flares.

It became clear that this was a significant unmet need. With Eysuvis, we used loteprednol—an inherently safe steroid, but one that does not penetrate the eye well—with our Ampplify technology so that three-to-four times more drug enters the target tissue. We’ve demonstrated clinically that Eysuvis can start working in the first few days and has excellent efficacy through two weeks. It also has an excellent tolerability profile, and the safety profile has been comparable to vehicle.

Only about 10% to 12% of diagnosed dry eye patients get a prescription therapy. We have found that problems with efficacy and tolerability are part of the reason for this. We think that dry eye patients who aren’t on a prescription therapy today can benefit from trying Eysuvis.

Tell us your vision for the dry eye field in the short term (less than 5 years) and in the long term (20 years from now).

Causes of dry eye such as screen time and people living longer will continue to ramp up. In the short term, controlling inflammation and perhaps at some point being able to return the physiology back to normal would be disease modifying.

I think that for the next five-to-10 years, we’re going to see a focus on keeping the ocular surface healthy. Eysuvis can play a role in that by managing the flares that milder patients experience a few times a year. If patients start to need it more frequently, a maintenance therapy can be added, but the Eysuvis can be kept on hand for when flares occur. We often use the analogy of an albuterol inhaler, which is a first-line therapy for the exacerbations or the flares of asthma and is kept on hand by patients as a rescue therapy when needed. Having Eysuvis on hand for flares could help to better treat dry eye disease over the long term. CLS