Tempe, AZ, December 20, 2018 – SDC, a specialized strategic scientific consulting and data services Contract Research Organization (CRO) providing scalable clinical trial solutions, congratulates Ocular Therapeutix™, Inc. (NASDAQ: OCUL) on their recent announcement that the U.S. Food and Drug Administration (FDA) has approved DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery. Ocular Therapeutix reports that the FDA approval decision was made approximately one month ahead of the scheduled PDUFA date.
“On behalf of all of us at SDC, congratulations to Ocular Therapeutix on the recent FDA approval of DEXTENZA,” said Dale W. Usner, Ph.D., CSO & Sr. VP, Strategic Scientific Consulting at SDC. “We are proud to have supported the clinical trials and submission data for this important program. Congratulations on this exciting achievement!”
“We thank SDC for their expertise and support of the DEXTENZA program,” said Michael Goldstein, MD, CMO at Ocular Therapeutix.
For more information, please see the full and original press release dated December 3, 2018: OCULAR THERAPEUTIX™ ANNOUNCES FDA APPROVAL OF DEXTENZA® FOR THE TREATMENT OF OCULAR PAIN FOLLOWING OPHTHALMIC SURGERY.