A few days ago, shares of biopharmaceutical startup Ocular Therapeutix (NASDAQ:$OCUL) were plummeting — but on July 11, the company’s shares shot up by 26%. This is largely due to the fact that Ocular Therapeutix announced that it has submitted an amendment for its lead drug candidate Dextenza. The document contains information on changes to manufacturing equipment and how the company is following the feedback from the U.S. Food and Drug Administration (FDA) after inspections done at Ocular Therapeutix’s manufacture factories earlier 2017.
These actions were expected by investors, and marks the very first steps Ocular needed to take to start making plans in the right direction — particularly towards gaining approval from FDA to sell Dextenza on the market — after setbacks regarding the company’s manufacturing issues. Ocular’s stock closed at a 17.10% gain.
What happened
Phase 3 trials for Dextenza was completed several months ago. Dextenza includes a small medical device that can be put into a small opening of the eyelid after eye surgery — the device releases postoperative steroid therapy to help treat pain and/or inflammation one could experience after an eye surgery. A New Drug Application (NDA) was submitted by Ocular back in February and was accepted by the FDA. A decision is expected to be reached by July 19, 2017.
In the wake of rising success, however, Ocular ran into trouble in May 2017 when the FDA issued a Form 483 to the company. Inspections carried by the FDA showed that some manufacturing processes done by the company could contaminate Dextenza — an obviously unacceptable fact for a drug that will be in direct contact with the patient’s eyes.
Today, Ocular turned things around by responding appropriately to each issue in the Form 483 and submitting an amendment to Dextenza’s NDA. The company also requested for the FDA to extend its review date for another three months, as the July 19 deadline would leave the administration with little to no time to properly review the new information. If the request is accepted and the FDA responds positively to Ocular’s plans to resolve the issues found in its Form 483 and its NDA amendment, it could be very good news to both the company and its investors.
Now what
Investors can’t do much now besides wait for the FDA to respond to Ocular. While there are no certain guarantees that the manufacturing changes made by the biopharmaceutical company will be able aid its Dextenza operations, the company has had a history of manufacturing problems.
Once the problem that is causing the contamination is identified, it will be fairly easy for Ocular to address the problem with the right protocols. Although all investors can do now is wait, Ocular’s actions can help it gain a better chance regarding marketing approval for Dextenza and to finally being making some revenue.
Featured Image: twitter
