After twice being sidelined by manufacturing-related CRLs, Ocular Therapeutix got FDA approval on Monday for its first eye drug. The FDA nod came a month ahead of its latest PDUFA date after the eye specialist assembled a team to help it surmount FDA concerns over its production.
The agency approved Dextenza for the treatment of ocular pain following ophthalmic surgery. Dextenza is not only Ocular’s first drug but the first intracanalicular insert to be approved. It delivers the steroid dexamethasone for relief of pain for up to 30 days.
“We are extremely pleased to announce the approval of Dextenza coming so soon after our pre-approval inspection and approximately one month ahead of the PDUFA date,” CEO Antony Mattessich said in a statement.
“Just over a year ago, we set out to augment our scientific and formulation expertise with individuals who have the skills and experience to create a first-class team to get Dextenza approved and become a commercial stage biopharmaceutical company. We believe this approval is a major external validation of the drug delivery technology platform, and also of the transformation that has taken place at Ocular.”
It was in July 2017, when the Bedford, Massachusetts, biotech was issued a second complete response letter after the FDA found more issues at its manufacturing facility there. That CRL came almost exactly a year after the FDA first nixed its approval chances for Dextenza because of manufacturing problems.
The approval of Dextenza was based on two randomized phase 3 studies in which a statistically significantly higher number of patients were pain-free at day 8 following cataract surgery compared to the control group.
The company says the one-time placement of a single intracanalicular insert by a doctor can offer a full course of postsurgical steroid treatment compared to a “complex eye drop regimen that under the current standard of care requires up to 70 topical ocular steroid drops.”