Ocular Therapeutix Raises $37.5 Million in Debt Financing to Support Commercialization of DEXTENZA for Post-Ocular Surgery Pain Relief

On February 25, 2019, VCBeat (WeChat official account: vcbeat) learned that Ocular Therapeutix, headquartered in Bedford, Massachusetts, USA, announced on the 21st that it had entered into a purchase agreement with accredited investors to issue $37.5 million in aggregate principal amount of 6.00% subordinated convertible notes. The transaction is expected to close on March 1, 2019.

It is understood that Ocular Therapeutix is a biopharmaceutical company focused on the treatment of ocular diseases. The company leverages its proprietary bioabsorbable hydrogel formulation technology to formulate, develop, and commercialize ophthalmic therapeutic products, addressing unmet needs in eye care. Ocular Therapeutix’s product portfolio includes ReSure Sealant and DEXTENZA.

ReSure Sealant is a synthetic polyethylene glycol hydrogel that primarily serves as a synthetic ocular bandage in ophthalmic surgery. It is the first product approved by the U.S. Food and Drug Administration (FDA) for sealing clear corneal incisions following cataract surgery. The ReSure Sealant kit consists of two liquid solutions, which are mixed by the physician and applied to the wound using a foam applicator. Within 20 seconds, the mixture forms a gel that covers the surgical incision, sealing the wound and creating a smooth surface barrier. Over the course of one week, the gel gradually breaks down and is eliminated from the eye through natural tear flow.

DEXTENZA (dexamethasone intracanalicular insert) is a corticosteroid intracanalicular insert primarily used to alleviate ocular pain following ophthalmic surgery. After the surgeon completes the ophthalmic procedure, DEXTENZA is inserted into the natural opening of the lower eyelid (the punctum) and subsequently enters the canaliculus, where it releases the corticosteroid dexamethasone to relieve postoperative pain. Each insert contains a 0.4 mg dose and provides drug delivery for up to 30 days. DEXTENZA enables single-insertion steroid therapy and is made of bioabsorbable material, eliminating the need for removal and thereby improving the patient experience.

In 2016, Ocular Therapeutix submitted a New Drug Application (NDA) for DEXTENZA to the FDA, which was rejected. In July 2017, the company resubmitted its application, but the FDA again denied approval due to certain deficiencies in its manufacturing processes. One year later, Ocular Therapeutix secured FDA approval for its NDA for DEXTENZA. As a result, DEXTENZA became the first FDA-approved intracanalicular insert for drug delivery.

The FDA’s approval of DEXTENZA was based on a review of its efficacy and safety. Scientists conducted two randomized, vehicle-controlled Phase 3 trials, which demonstrated that the proportion of patients who reported no pain at Day 8 after cataract surgery was significantly higher in the DEXTENZA group than in the control group. The safety of DEXTENZA was also established in these two Phase 3 trials as well as in another randomized, controlled Phase 2 trial.

Ocular Therapeutix expects the net proceeds from this bond issuance to be approximately $37.1 million, which will be primarily used for the launch of DEXTENZA and its late-stage product pipeline. Mr. Antony Mattessich, Chairman and Chief Executive Officer of the company, stated, “Reforming drug delivery methods has always been our goal. Moving forward, we will strive to bring DEXTENZA to market and make it accessible to more patients.”