FDA accepts to review Ocular Therapeutix’s NDA for DEXTENZA

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™.

Ocular Therapeutix president, CEO and chairman Amar Sawhney said: "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.

"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 natural opening in the eyelid, into the canaliculus and is designed to deliver dexamethasone to the ocular surface for four weeks. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without need for removal. To capitalize on the broader opportunity for the sustained delivery of corticosteroids to the front of the eye, the Company is pursuing multiple indications for DEXTENZA. These include treatment of:

post-surgical ocular pain
post-surgical ocular inflammation
ocular itching associated with allergic conjunctivitis
signs and symptoms associated with inflammatory dry eye disease

In addition to the NDA submission for the treatment of ocular pain following ophthalmic surgery, the Company has recently initiated a third Phase 3 clinical trial for post-surgical ocular inflammation and pain. The Company also recently completed its first Phase 3 clinical trial for allergic conjunctivitis and reported that DEXTENZA successfully met the primary endpoint for the treatment of ocular itching associated with allergic conjunctivitis, and recently initiated a second Phase 3 clinical trial for this indication.

Subject to approval of the NDA for post-surgical pain and subject to obtaining favorable results for the Phase 3 trial of DEXTENZA for post-surgical ocular inflammation and pain, the Company intends to submit supplements to the NDA for the treatment of post-surgical inflammation, as well as for itching associated with allergic conjunctivitis, to seek to broaden DEXTENZA’s label.

The Company has also completed patient enrollment in an exploratory Phase 2 clinical trial of DEXTENZA for the treatment of inflammatory dry eye and expects to report topline efficacy data from this trial in December of 2015.