Drug-loaded plug eases adherence issues for patients, physicians

Reviewed by Joseph Gira, MD

St. Louis, MO-A novel sustained drug depot that aims to treat ocular pain and inflammation after cataract surgery-while also allaying concerns associated with adherence-has moved one step closer toward approval. 

Ocular Therapeutix submitted its dexamethasone intracanalicular depot (Dextenza) for FDA approval for postsurgical ocular pain following two successful phase III trials, said lead author Joseph Gira, MD, who presented the results of two phase III trials.

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“After cataract surgery, using dexamethasone drops is extremely important,” said Dr. Gira, Ophthalmology Consultants, St. Louis, MO.

Drops can help prevent inflammation, prevent macular edema, and ensure good outcomes in regard to vision, he noted.

“But we have to rely on patients to administer drops and a lot of patients are not very compliant with their medications,” Dr. Gira added. “The depot plug takes it out of the patient’s hands. You insert the plug with the drug already loaded at the conclusion of surgery, and that’s it.”

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Phase III outcomes

Both trials met the endpoints for postsurgical pain, but only one trial met the endpoints for postoperative inflammation.

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Both studies used a polyethylene glycol-based hydrogel drug depot inserted into the lower vertical canaliculus following cataract surgery. Patients either received a plug containing 0.4 mg of dexamethasone or a placebo plug. The drug-loaded plug is intended to replace the steroid eye drops typically prescribed following cataract surgery.

The plugs provide sustained and tapered drug delivery to the ocular surface for up to 30 days. Once inserted, the plugs are invisible under normal light but fluoresce yellow under blue light for easier placement and to confirm retention.

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