Kala to Take Another Shot at FDA Approval With New Dry Eye Drug Data

Xconomy Boston — 

A Kala Pharmaceuticals dry eye disease drug that was rejected by the FDA is now being readied for another regulatory filing based on new data.

Last August the FDA rejected a Kala (NASDAQ: KALA) product meant to temporarily relieve signs and symptoms of dry eye disease. On Monday the Watertown, MA-based biopharma announced preliminary results from an additional clinical trial—which the agency said the company would need to support the resubmission of the product—showing that the eye drops improved patients’ eye pain better than a version without the active ingredient.

The drug itself isn’t new: It’s a formulation of loteprednol etabonate, a Bausch Health (NYSE: BHC) topical steroid that the FDA has approved to treat pain and inflammation after eye surgeries. That formulation, which Kala markets as Inveltys, a twice-daily eye drop, launched in January 2019.

The formulation designed for dry eyes was tested in STRIDE 3 (for “short term relief in dry eye”), which enrolled about 900 patients. At day 15, the patients receiving the eye drops—which were administered four times daily—reported a statically significant improvement in the severity of their eye pain as reported by the patients on a rating scale, compared to a version of the treatment without its active component, Kala said Monday. A subset of dry eye patients with a more level of severe discomfort also reported improvement, the trial’s other main goal.

People with dry eye, a common eye problem due to the decreased production of tears, may experience discomfort, sensitivity to light, and excessive production of so-called “irritant” tears, which don’t lubricate as well as heathy tears. Such symptoms can spike from time to time, an occurrence known as a flare, which Kala says its product is better positioned to treat than existing drugs given its ability to more rapidly provide relief of signs and symptoms.

Like it did with its previous formulation of loteprednol etabonate, Kala developed the new treatment using nanoparticle technology that it says improves the efficacy of a drug by making its distribution more even and better penetrating mucosal surfaces.

Kala sees this latest formulation as a potential successor to existing prescription treatments for dry eye, such as Novartis’s lifitegrast (Xiidra), which the pharma acquired from Takeda Pharmaeutical (NYSE: TAK) in a $3.4 billion deal last March, and the Allergan (NYSE: AGN) product cyclosporine ophthalmic emulsion (Restasis). Those products can take weeks or months to have an effect, while the Kala drug, which was designed to be taken and have its effect within two weeks, the company says.

“Based on our interactions with both ophthalmologists and optometrists, we believe Eysuvis has the potential to become the preferred prescription therapy of the short-term treatment of dry eye,” Todd Bazemore, Kala’s chief operating officer, said during a conference call Monday.

While well tolerated by patients, the most common side effect in STRIDE 3 was pain at the site where the drug was given, which was reported by 2.9 percent of those receiving the drug compared to 1.5 percent of the other patient group. Topical corticosteroid administration is known to cause elevations in intraocular pressure, but rates of that side effect were similar between the two groups, Kala said.

Kala plans to submit the product to the FDA for review in the second quarter and, if approved, says it could launch it by year’s end.

To launch Eysuvis, Kala plans to build on the infrastructure it set up to market Inveltys, its first commercial product in the US, growing its sales force from roughly 60 representatives to as many as 125, a group that would promote both products.

Image: iStock/fitzkes