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Why Ocular Therapeutix Will See Approval For DEXTENZA In The Next Few Days

Summary

Both Phase 3 trials were positive in the applied for pain indication.

Significant number of patients with no pain compared to placebo despite use of other anti-inflammatory drugs.

There are no approved sustained release steroidal products and there are potential problems with traditional eye drops.

Ocular Therapeutix (NASDAQ:OCUL) is a biopharmaceutical company focused on diseases and conditions of the eye, with one product approved (see Figure 1) by the Food and Drug Administration (FDA). Ocular is developing its lead product candidate, DEXTENZA (sustained release dexamethasone) 0.4 mg Intracanalicular Depot using the company's proprietary hydrogel platform technology, for post-surgical ocular pain and inflammation, allergic conjunctivitis, and dry eye disease. The FDA is reviewing a New Drug Application (NDA) for DEXTENZA for the pain indication and has a Prescription Drug User Fee Act (PDUFA) target action date of July 24.

Figure 1. Ocular Therapeutix Pipeline

DEXTENZA delivers a 30-day course of anti-inflammatory steroid with a single application of a depot in the tear punctum and underwent two Phase 3 prospective multicenter parallel-arm randomized (double-masked vehicle)-controlled trials (RCTs). In the first RCT which enrolled 247 patients, 76.1% of DEXTENZA patients...


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