Ocular Therapeutix (OCUL) Tops Q1 EPS by 4c; Sees DEXTENZA NDA Submission in H215

Ocular Therapeutix (NASDAQ: OCUL) reported Q1 EPS of ($0.35), $0.04 better than the analyst estimate of ($0.39).

Clinical Update for DEXTENZA for the Treatment of Post-Surgical Ocular Inflammation and Pain

Following a Pre-NDA Clinical meeting held with FDA in April 2015, Ocular Therapeutix is charting a path forward for DEXTENZA for the treatment of post-surgical ocular inflammation and pain. The Company’s plan now includes:

• Submission of an NDA for DEXTENZA for a post-surgical ocular pain indication in the second half of 2015.
• Initiation of an additional Phase 3 clinical trial for DEXTENZA for post-operative ocular inflammation and pain with modifications to the trial design based on learnings from the previously completed second Phase 3 trial, including the exclusion of patients on high-dose nonsteroidal anti-inflammatory drugs (NSAIDs), randomizing patients in a 1:1 ratio into treatment and placebo groups and providing more protocol specificity regarding the administration of rescue medications.
• Submission of an NDA supplement for DEXTENZA to broaden the indication to include treatment of post-operative ocular inflammation, subject to favorable results from the additional Phase 3 clinical trial and the approval of the NDA for DEXTENZA for the pain indication.

For earnings history and earnings-related data on Ocular Therapeutix (OCUL) click here.

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