Kala Pharmaceuticals, Inc. (NASDAQ: KALA) shares dipped on Thursday after the US Food and Drug Administration (FDA) announced that the INVELTYS (loteprednol etabonate ophthalmic suspension) had approved 1% for the treatment of post-operative inflammation and post-ocular eye pain.
In most cases FDA approval would help to increase inventory, but this seems to be the case for selling the news for Kala Pharma.
What separates INVELTYS from the rest is that it is a twice daily (BID) ocular corticosteroid, while all other ocular steroids are approved for a dosage of four times a day. This more frequent dosing requirement can cause problems for both doctors and patients.
Apart from that, Kala continues 0.25% KPI-121 for dry eyes. The company has started a third Phase 3 clinical phase, STRIDE 3 (STRIDE – Short-term Relief In Dry Eye), assessing KPI-121 0.25% for temporary relief of the signs and symptoms of dry eye.
Kim Brazzell, Ph.D., Chief Medical Officer of Kala, commented on the approval:
The FDA approval from INVELTYS is a great milestone for Kala. Approximately 8 million patients undergo ocular operations each year. The INVELTYS approval offers patients and their eye care professionals the first and only BID treatment with ocular corticosteroids that have been shown to be clinically effective in clinical trials, while maintaining a proven safety profile, which can improve adherence and reduce the burden on patients. patients. We believe that INVELTYS will be an important addition to the treatment armamentarium of eye care professionals.
The Kala shares were last seen at around 4% against $ 12.98, with a consensus price target of $ 30.80 and a 52-week range of $ 11.39 to $ 26.75.