The news comes less than a month after the US Food and Drug Administration (FDA) rejected Ocular’s eye pain treatment Dextenza (dexamethasone insert), for a second time.
The firm said it “expects to realise savings in operating expenses, including personnel costs, as a result of streamlining headcount by approximately 19% as part of an initiative to enhance operations and reduce expenses.”
According to Ocular, the restructure will secure its finances for the coming year, and allow it to focus on drug candidate Dextenza.
“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 services obligations and capital expenditure requirements through the third quarter of 2018.”
“Cost savings will enable Ocular to focus on advancing its pipeline, including Dextenza for the treatment of ocular paint and inflammation following ophthalmic surgery,” said the firm.
Dextenza
Last month the US FDA rejected Ocular’s Dextenza – a hydrogel-based dexamethasone depot designed to be inserted through the tear duct - in a complete response letter (CRL), citing concerns about how the drug is made and tested.
At the time, the firm said, “The CRL refers to deficiencies in manufacturing processes and analytical testing related to the manufacture of drug product for commercial production.”
This is the second CRL Ocular has been issued for Dextenza, the first of which was issued in July, 2016.
A summary of Dextenza’s regulatory history can be found here.