Kala Pharmaceuticals shares soar after FDA approves trial for drug to treat PCED
Shares of Kala Pharmaceuticals surged Wednesday after the small biotechnology company announced a drug candidate for a rare eye disease.
The Food and Drug Administration has accepted Kala's investigational drug application for KPI-012, a potential treatment for persistent corneal epithelial defect, or PCED, the Arlington, Massachusetts-based company announced on Tuesday.
Kala shares soared $9.45, or 266%, Wednesday to $13.52.
The agency's acceptance of Kala's drug application "is an important milestone" for the company as it works to improve outcomes for those living with rare ocular surface diseases, Kim Brazzell, head of R&D and Chief Medical Officer at Kala, said in a statement.
About 100,000 cases of PCED occur in the U.S. each year. The disease can lead to significant loss of vision, among other things, Kala stated.
"We are now turning our focus to clinical execution," Brazzell said. "We are working closely with investigators to initiate our Phase 2b clinical trial of KPI-012 for PCED in the first quarter of 2023."
If drug is cleared for use, it could become the first first approved treatment for PCED, according to Kala. The company expects to start enrolling patients in its trial in the first quarter of 2023 and to report preliminary results in early 2024.
