Health and Healthcare

FDA Ignites Ocular Inflammation Treatment Dextenza in Most Recent Approval

Chris Lange

Published: June 21, 2019 10:08 am

Last Updated: January 6, 2020 3:33 am

Ocular Therapeutix, Inc. (NASDAQ: OCUL) shares jumped on Friday after the firm announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Dextenza to include, as an additional indication, the treatment of ocular inflammation following ophthalmic surgery.

With the approval of the sNDA, Dextenza is now approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.

The approval of this sNDA was supported by three Phase 3 vehicle-controlled trials. In all three trials, Dextenza had, at a statistically significant level, a higher proportion of patients than the vehicle group who were pain-free on post-operative on Day 8. On post-operative Day 14, in two of the three studies, Dextenza had a higher proportion of patients than the vehicle group, at a statistically significant level, than those who had an absence of anterior chamber cells.

Originally, Dextenza received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery.

Antony Mattessich, the company’s president and CEO, commented:

We could not be more excited about both the approval and its earlier-than-expected timing. With our C-Code and pass-through payment status effective on July 1, the expanded indication gives us tremendous momentum as we approach our commercial launch.

Shares of Ocular Therapeutix were last seen up about 7% at $4.41, with a 52-week range of $2.35 to $7.79. The consensus analyst price target is $9.67.