Ocular Therapeutix Gains FDA Alignment for Axpaxli Submission

The Bedford, Massachusetts-based biopharmaceutical firm intends to leverage a specialized regulatory pathway designed to shave up to two months off the standard FDA review process. If the submission proceeds as scheduled in the fourth quarter, the company anticipates a commercial rollout for the therapy the following year.

Investors reacted positively to the update, sending company shares up 3% to $9.22 in pre-market trading. This alignment removes a significant hurdle for the company as it works to position Axpaxli within the competitive ophthalmology market.