DEC 06, 2018
Cataract/Anterior Segment, Comprehensive Ophthalmology
Ocular Therapeutix announced FDA clearance of their dexamethasone punctum plug (Dextenza) for managing ocular pain after cataract surgery. The implant is the first intracanalicular drug delivery device.
Dextenza manages pain by dispelling 0.4 mg of preservative-free dexamethasone over a 30-day period. It is inserted through the lower lacrimal punctum into the canaliculus, where it is activated by moisture and swells to securely fit. The implant slowly reabsorbs during treatment and exits via the nasolacrimal, eliminating the need for surgical removal.
“The approval of Dextenza offers surgeons the opportunity to treat patients with a preservative-free steroid after surgery with the placement of a single drug insert,” said Michael Goldstein, MD, the company’s chief medical officer. “With this product, patients may be liberated from having to deal with the burdensome regimen of using steroid eye drops after ophthalmic surgery.”
The recent FDA approval of Dextenza was based on multiple clinical studies. Two randomized, vehicle-controlled phase 3 studies demonstrated a higher percentage of Dextenza patients who were pain free at day 8 post-cataract surgery compared with controls. Of the 351 patients treated with Dextenza, 9% experienced anterior chamber inflammation and 5% had increased IOP; reduced visual acuity, eye pain, cystoid macular or corneal edema and hyperemia affected less than 2% of patients.
The regulatory nod comes after 2 prior rejections stemming from manufacturing deficiencies, which resulted in staff cuts and management shake-ups. Despite the welcome news, the press release did not offer any details about when the implant would be made available.