Shire’s Steven Zhang, M.D., Ph.D., joined Kala Pharmaceuticals to lead its medical affairs work as it begins transitioning to a commercial-stage ophthalmic company.
Kala received an FDA approval in August for Inveltys, a twice-daily, 1% corticosteroid solution for ocular pain and inflammation after eye surgery, and is preparing to launch the product in early 2019.
The Waltham, Massachusetts-based company is also developing a 0.25% eye drop solution of Inveltys’ active ingredient, KPI-121, for temporary relief from the symptoms of dry eye disease. The phase 3 candidate has completed two trials with a third still ongoing, and Kala submitted its application to the FDA using its current dataset earlier this month.
Kala’s platform is built around mucus-penetrating nanoparticles with a non-covalent coating that allows them to distribute evenly across the surface of the eye at a higher concentration, compared to other drops that may be trapped or eliminated by the body’s tear film layer.
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“Inveltys and KPI-121 0.25% have the potential to be significant additions to the treatment armamentariums for post-surgical inflammation and pain and dry eye disease, respectively,” Zhang said in a statement.
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At Shire, Zhang served as senior director, medical lead of the company’s global ophthalmic franchise and development programs, and headed its U.S. ophthalmic medical affairs, where he helped launch the Xiidra dry-eye solution.
Before that, he spent six years in medical affairs for Bausch + Lomb, supporting the launches of more than 15 ophthalmic products and devices, and was also the national clinical science manager at Abbott Labs’ respiratory and anti-infective franchise.
Editor's note: This story has been corrected to reflect Kala's recently submitted NDA.