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… Read more »
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