Ocular Therapeutix Inc. (NASDAQ: OCUL) recently provided a number of updates regarding its candidate called DEXTENZA for treatment of post-surgical ocular pain.
The company earlier said that the FDA had raised several issues in a complete response letter (CRL) after it submitted New Drug Application (NDA) for the candidate to the regulator.
In another response letter, the FDA said that it was satisfied by the proposed actions to address the issued it had raised in the earlier letter, save for one issue that relates to identity testing.
That issue is still pending and it appears to be the only major thing standing between DEXTENZA and its launch on the market. So what’s Ocular Therapeutix Inc. (NASDAQ: OCUL) saying about it? The management of Ocular continues to exude confidence that DEXTENZA will soon come to market.
In a recent update, the management said that it was working to resolve the one pending issue that is delaying the final NDA review. As such, the company said that it is working closely with FDA. On top of that, Ocular has already embarked on labeling talks with the FDA.
The message that Ocular management is trying to send out is that it remains committed to see that DEXTENZA launches on the market as soon as possible. The company hopes to resolve the remaining issue before the end of the current quarter.
Besides making efforts to bring DEXTENZA to market, Ocular Therapeutix Inc. (NASDAQ: OCUL) is also planning two Phase 3 studies of its other candidate called OTX-TP. The compound is being developed for treatment of ocular hypertension and glaucoma and the first Phase 3 trial is expected to begin in 3Q2016.
How Ocular Therapeutix Inc. (NASDAQ: OCUL) fared in 2Q
Ocular generated revenue of $0.44 million in 2Q2016, which dipped 4.3% YoY and missed the consensus estimate of $0.55 million. But EPS loss of $0.46 was better than the consensus estimate for EPS loss of $0.49.
Ocular Therapeutix Inc. (NASDAQ: OCUL) finished 2Q with cash and equivalents totaling $83.9 million, which is offset by outstanding debt amount of $15.6 million. The management said that the available cash should be adequate to fund operations and capital expenditure through 3Q2017.