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Ocular Therapeutix™ Announces FDA Acceptance of NDA Filing for DEXTENZA™ for the Treatment of Post-Surgical Ocular Pain

BEDFORD, Mass.--(BUSINESS WIRE)--Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the New Drug Application (NDA) for DEXTENZA™ (sustained release dexamethasone), Intracanalicular Depot, for the treatment of ocular pain following ophthalmic surgery, has been accepted for review by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA by the FDA in its 74-day letter indicates that the application permits a substantive review and there are no issues that have been identified at present that would delay the FDA’s review progress. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of July 24, 2016 for potential FDA approval of DEXTENZA™.

“We are pleased that Ocular Therapeutix’s first NDA filing with our lead product candidate, DEXTENZA, has been officially accepted for review by the FDA. This is an important milestone for the Company and we will continue to work diligently with the FDA as they complete their review”

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“We are pleased that Ocular Therapeutix’s first NDA filing with our lead product candidate, DEXTENZA, has been officially accepted for review by the FDA. This is an important milestone for the Company and we will continue to work diligently with the FDA as they complete their review,” said Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman. “DEXTENZA would provide a full post-operative course of therapy with one-time administration as compared to the current standard of care, which requires a complex and tapering regimen of multiple eye drops on a daily basis. We are excited to potentially offer both surgeons and their patients a novel alternative to steroid eye drop therapy.”

The data included in the NDA are from a Phase 2 clinical trial and two Phase 3 clinical trials conducted with DEXTENZA for the treatment of post-surgical ocular inflammation and pain. Based on the results of these trials and following a Pre-NDA Clinical meeting with the FDA, the Company submitted an NDA for the treatment of post-surgical ocular pain.

“DEXTENZA is designed to give a patient an entire 30-day course of medication with a single application of a depot, placed by the doctor in the tear punctum. Patients don't have to take the medication themselves, and doctors don't have to wonder whether patients are being compliant. This is a novel development in ophthalmology. It is also exciting to consider the additional possibilities the company is pursuing for DEXTENZA, as a one-time use steroid with a strong safety profile that could have broad applicability in ophthalmology,” stated John Hovanesian, MD, Clinical Faculty, UCLA Jules Stein Eye Institute (Los Angeles, CA) and Harvard Eye Associates (San Clemente, CA).

About DEXTENZATM

DEXTENZA (sustained release dexamethasone) Intracanalicular Depot is placed through the punctum, a...


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