Ocular Therapeutix to Slash Jobs After FDA Rejection
Published: Aug 04, 2017
August 2, 2017
By Alex Keown, BioSpace.com Breaking News Staff
BEDFORD, Mass. – One month after the U.S. Food and Drug Administration rejected its post-eye surgery pain treatment, Ocular Therapeutix is slashing 19 percent of its employees, including a senior executive, and has tapped a new chief executive officer.
This morning, the company announced its new strategic initiative it hopes will enhance operations and reduce expenses. Restructuring costs are expected to be about $1.5 million, the company said. The long-term costs from terminating 26 employees will allow the company to focus its energies on securing regulatory approval for Dextenza, the post-surgical pain treatment the FDA spurned in July, as well as other ophthalmic therapies.
In July, the FDA sent Massachusetts-based Ocular a Complete Response Letter that said the agency could not approve Dextenza, a dexamethasone insert, in its present form. The FDA’s CRL pointed to deficiencies in the manufacturing process, as well as concerns over analytical testing related to the manufacture of the drug that the FDA identified during a “pre-NDA approval inspection” of Ocular Therapeutix’s new manufacturing facility. The company submitted an amendment to its New Drug Application to address some of the concerns the FDA raised prior to issuing the CRL, but by the time Dextenza was rejected the FDA said it had not had an opportunity to review the amended NDA. Ocular has hope that once the FDA is satisfied with the manufacturing issues it will approve Dextenza, particularly since there were no questions raised regarding its efficacy or safety.
In addition to seeking approval of Dextenza, Ocular Therapeutics is also focused on the development of OTX-TP (travoprost insert) and OTX-TIC (glaucoma injection) for the treatment of glaucoma and ocular hypertension, as well as extended release intravitreal depots for the treatment of serious retinal diseases. The company is also collaborating with Tarrytown, N.Y.-based Regeneron to develop a new extended release formulation of that company’s approved drug, Eylea. Ocular and Regeneron are combining their efforts to develop a sustained release form of Eylea (aflibercept), a vascular endothelial growth factor trap, for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases. Eylea, which is injected into the eyes, is approved for wet AMD, as well as macular edema following retinal vein occlusion.
The employees Ocular terminated includes at least one executive, Andy Hurley, the company’s chief commercial officer. Cost savings from the restructuring and job cuts are expected to provide the company with enough funds to finance operations through the third quarter of 2018, the company said.
Ocular also finally onboarded Antony Mattessich as the company’s new CEO. Mattessich, who most recently served as CEO of Mundipharma International, will replace former CEO Amar Sawhney, who is transitioning to the role of executive chairman of the company’s board of directors.
“I am excited to begin my role as CEO of Ocular Therapeutix at such an important juncture for the Company,” Mattessich said in a statement. “As I begin my tenure, I would like to reiterate that we remain committed to Dextenza, while we also focus our efforts on the development of the entire breadth of innovative drug product solutions that the team has built under Amar’s guidance.”
Shares of Ocular Therapeutix are up to $6.46 in premarket trading.