Ocular Therapeutix Dextenza NDA accepted by FDA

Ocular Therapeutix (NSDQ:OCUL) said today the FDA accepted the new drug application for its drug-device combo Dextenza for treating ocular pain following ophthalmic surgery.

Bedford, Mass.-based Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear duct. The plug then dissolves and is flushed from the body as tears.

“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,” CEO Amar Sawhney said in a press release.

Ocular Therapeutix said the acceptance indicates that no issues which could cause a serious delay of the review process have been identified, and the FDA set a target action date of July 24, 2016 for potential FDA approval of Dextenza.

“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,” Dr. John Hovanesian of Los Angeles’ UCLA Jules Stein Eye Institute said in a prepared statement.

Data included in the NDA are from a Phase II clinical trial and 2 Phase III trials of the drug for treating post-surgical ocular inflammation and pain.

Last month, Ocular Therapeutix launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication.

In March, Ocular said a 1st, 247-patient trial examining Dextenza for reducing pain and inflammation after cataract surgery showed that 33.7% of the Dextenza arm showed no inflammatory cells after 14 days, compared to 14.6% for the placebo control arm. Some 76.1% of patients receiving the drug reported no pain after 8 days, compared to 36.1% of the placebo arm.

But Dextenza failed to meet a key endpoint the 2nd clinical trial for the pain & inflammation indication, the company said in April. The 240-patient trial met its pain endpoint but missed the inflammation endpoint. Although 77.5% of patients in the Dextenza arm reported no pain after 8 days, compared with 58.8% of the control arm, the difference in inflammatory cell counts after 14 days was not statistically significant (39.4% vs. 31.3%), the company said, noting that both endpoints had to be met to consider the study a success.

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