Ocular Therapeutix, a biopharmaceutical company focused on eye-care products, has announced a restructuring involving employee reductions of 19% of its workforce and has named a new chief executive officer (CEO).

In July 2017, the company received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its resubmission of a new drug application (NDA) for Dextenza (dexamethasone) for treating ocular pain following ophthalmic surgery.

The CRL referred to deficiencies in manufacturing processes and analytical testing related to the manufacture of the drug product for commercial production identified during a pre-NDA approval inspection of Ocular Therapeutix’s manufacturing facility that was completed in May 2017.

Ocular Therapeutix says that it expects to realize savings in operating expenses, including personnel costs, as result of streamlining headcount by approximately 19%, as part of an initiative to enhance operations and reduce expenses. In conjunction with this initiative, Andy Hurley, chief commercial officer, will be leaving the company. With these anticipated cost savings and based on the company’s current plans and forecasted expenses, the company believes that existing cash and cash equivalents and marketable securities will fund operating expenses, debt service obligations, and capital expenditure requirements through the third quarter of 2018.

The company has also named Antony Mattessich as CEO, effective immediately, and transitioned former CEO Dr. Amar Sawhney to executive chairman of the Board.  Mattessich most recently served as CEO of Mundipharma International, a developer and commercializer of products in pain, inflammation, cancer, and respiratory diseases. Mattessich also held leadership roles at global pharmaceutical companies, including at Novartis, Bristol-Myers Squibb, and Merck & Co.

Source: Ocular Therapeutix