Once rejected, Kala's dry eye drug now gains entry to a field where Novartis is grooming its own blockbuster
When the FDA slapped a rejection on Kala Pharma’s dry eye drug last August, the biotech’s execs promised investors that a third Phase III study — they had already started at that point — would reverse their fortune.
Today they made good on that promise, clinching an approval for Eysuvis, an ocular corticosteroid being positioned as a first-line, short term treatment of dry eye disease.
Boasting a technology invented by Bob Langer out of MIT, Eysuvis is a corticosteroid, loteprednol etabonate, delivered by mucus-penetrating particles. It promises to enhance penetration into target tissue on the ocular surface, achieving an effect quicker than systemic corticosteroids and stronger than over-the-counter eye drops.
Kala, with $159.1 million in cash, cash equivalents and short-term investments that it expects to last until Q3 of 2022, expects to launch the drug by year’s end pending some final touches on the salesforce (125 reps to start with) and manufacturing.
The top team, led by CEO Mark Iwicki, has repeatedly emphasized that the market is huge yet untapped, with just a few prescription drugs available in the category. One of them, Shire’s Xiidra, was bought by Novartis for $3.4 billion upfront.
Here’s Iwicki from an earnings call in August:
Over 30 million people in the United States live with dry eye disease, of which over 17 million have already been diagnosed by an eye care professional.
Our market research suggests that 80% to 90% of these patients suffer from episodic flares rather than continuous symptoms, and feedback from eye care professionals suggest that these flares are – will be under-managed by current therapies.
In a note from September, Jefferies analyst Biren Amin wrote that steroids are commonly prescribed off-label for flares but risks of elevated intraocular pressure discourage non-corneal specialists from doing so.
Data from STRIDE3, the final Phase III study that finally satisfied regulators, suggested that Eysuvis induced a statistically significant improvement in ocular discomfort severity over placebo.
Doctors Amin spoke to “see the opportunity for it to be adopted by corneal specialists and should remove the barrier for non-corneal specialists to prescribe a steroid type treatment for DED flares.”