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Kala Pharma Tumbles Despite FDA Approval of Dry Eye Drug

Kala Pharmaceuticals slides even after the FDA approves its dry-eye disease treatment.
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Kala Pharmaceuticals  (KALA)  was sliding Tuesday even after the biopharma said the Food and Drug Administration approved its short-term treatment for signs and symptoms of dry-eye disease.

Shares of the Watertown, Mass.-based were down 10.36% to $6.92.

Kala Pharmaceuticals said Eysuvis is the first approved prescription therapy specifically for short-term treatment of the chronic, episodic disease that affects the tears and ocular surface.

The FDA approved Eysuvis based on results from four clinical trials, including three Phase 3 trials and one Phase 2 trial, the company said.

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Kala said that as of Sept. 30 it had  cash, cash equivalents and short-term investments of $159.1 million.

Kala said it anticipates that its existing cash, cash equivalents and short-term investments, along with sales of Inveltys, its pain treatment for post-ocular surgery, will enable it to fund its operations into at least the third quarter of 2022, with additional cash runway expected based on revenues from sales of Eysuvis.

In August, Kala reported second-quarter net product revenue of $800,000 related to sales of Inveltys, down $2.1 million from the year-ago quarter. Revenue was affected by a reduction in ocular surgeries due to restrictions related to the coronavirus pandemic.

The company reported a loss of $23.3 million, or 42 cents a share, compared with a loss of $23.8 million, or 70 cents, in the year-ago period.

"The FDA approval of Eysuvis as the first prescription therapy specifically developed to address the short-term treatment needs of people living with dry eye disease is a major accomplishment for Kala and an important moment for patients, who have been waiting for an FDA-approved, safe, effective and fast-acting therapy," said Mark Iwicki, chairman, president and CEO, in a statement.