The FDA has accepted for review Ocular Therapeutix's new drug application for sustained release dexamethasone to relieve ocular pain in patients post-ophthalmic surgery.
The FDA has accepted for review Ocular Therapeutix’s new drug application for sustained release dexamethasone (Dextenza) to relieve ocular pain in patients post-ophthalmic surgery.
If accepted, Dextenza would provide patients with a 30-day course of medication in a single application in the tear punctum.
“Dextenza would provide a full post-operative course of therapy with 1-time administration as compared with the current standard of care, which requires a complex and tapering regimen of multiple eye drops on a daily basis,” said Amar Sawhney, president and CEO of Ocular Therapeutix, in a press release. “We are excited to potentially offer both surgeons and their patients a novel alternative to steroid eye drop therapy.”
Ocular Therapeutix is also seeking approval for other indications beyond ocular pain, including relief of post-surgical ocular inflammation and ocular itching associated with allergic conjunctivitis.
The FDA’s acceptance of the application was based off phase 2 and phase 3 studies.
Dextenza exits the nasolacrimal system without needing to be removed from the patient.
The FDA has set a target action date of July 24, 2016, for the drug application.