Two years back, Kala Pharmaceuticals scored its first approval for the eye med Inveltys. Now, armed with a second ophthalmology nod, the company hopes to corner the market on a prolific, yet under-treated disease.
Tuesday, the FDA approved Watertown, Massachusetts-based Kala's Eysuvis for short-term treatment of the signs and symptoms of dry eye disease, the company said. It's the first prescription med approved in that indication, Kala said.
To improve penetration of the drug into the eye, Eysuvis leverages the company’s Ampplify mucus-penetrating particle (MPP) drug delivery technology. Those Ampplify particles are able to move more easily through mucus, which keeps them from getting trapped or eliminated, Kala CEO Mark Iwicki said on a call with analysts after the approval.
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Tens of millions of Americans suffer from dry eye disease, with about 17 million diagnosed and already under a doctor's care, but between 85% to 95% of them don’t take prescription drugs for their condition, COO Todd Bazemore estimated.
As for how Kala plans to capture that large—but apparently unwilling—audience, the company plans to grow its salesforce to 90 sales reps from 56 before the year is out and aims to bring that number up to 125 by 2021, Bazemore said. The company also aims to roll out “digital mediums” of its own to target patients directly—once it’s briefed its targeted prescribers.
There’s “a significant amount of excitement and pent up demand” among both doctors and patients for a treatment like Eysuvis, Bazemore said—a drug that works quicker than available meds and actually curbs inflammation, unlike artificial tears, which only offer temporary relief from symptoms.
The FDA based its approval on three phase 3 trials showing Eysuvis reduced conjunctival inflammation after two weeks of treatment. In two out of the three studies, the drug reduced the severity of eye discomfort across the study population and in a predefined subgroup that came into the trial suffering more severe discomfort, Kala said in a release.
The drug also offers rapid relief—charting improvements in patients’ comfort by day two or day three post-treatment, CMO Kim Brazzell said. That should make Eysuvis a clear preference over existing prescription options, which need to be taken over long stretches of time, work slowly and also carry a greater risk of side effects, the company figures.
Plus, this isn’t the company’s first ophthalmology rodeo. Kala in August 2018 snared a green light for another corticosteroid suspension, Inveltys, to treat ocular pain and inflammation after surgery. It plans to leverage its existing relationships with ophthalmologists and optometrists to build interest and train prescribers before a launch planned before year-end.
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But analysts on the approval call were skeptical about Kala’s launch plans and early adoption of Eysuvis amid ongoing pandemic disruptions to the healthcare system. Inveltys, for example, took a nasty beating from the pandemic as patients delayed surgery visits this year.
Kala figures Eysuvis has an advantage over Inveltys, though: Health consultations for dry eye disease are far better suited to telehealth and virtual medicine.
Kala hasn’t released a price for the drug, but during the call, stood by previous guidance that Eysuvis’ cost would land somewhere between that of branded steroids and other branded prescription dry eye therapies.