Sustained-release formula may obviate need for post-cataract steroid therapy

Take-home message: Two phase III trials evaluated sustained-release dexamethasone for the treatment of inflammation and pain after cataract surgery.

Reviewed by Thomas R. Walters, MD

Austin, TX-The first sustained-release dexamethasone formulation for the treatment of pain following cataract surgery is under review by the FDA.

The submission followed successful completion of two phase III clinical trials for the first sustained-release topical steroid for ophthalmic use. If approved, the new formulation would obviate the need for steroid eye drops after cataract surgery.

“Compliance with drop therapy after cataract surgery is always an issue,” said Thomas R. Walters, MD, of Texan Eye in Austin.

“When we have breakthrough inflammation postoperatively, it is more commonly from compliance than other issues,” he said. “This will allow us to place the drug device immediately post-surgery, in the operating room, to deliver a stable, safe and sustained steroid therapy for a month. That is one less drop the patient will need to use postoperatively.”

Dr. Walters presented data from two U.S. studies to examine the use of sustained-release dexamethasone for inflammation 14 days after surgery and pain 8 days postoperatively. Both trials met the pain endpoint but one trial failed the inflammation endpoint. Both trials showed solid evidence of safety.

Both studies used a punctum plug composed on a polyethylene glycol-based hydrogel impregnated with 0.4 mg of dexamethasone compared with placebo. The plugs are implanted at the end of surgery to release a constant level of drug for a set period. The plugs are eventually resorbed and flushed via the nasolacrimal system and do not need to be removed. The plugs are not visible under normal illumination but fluoresce under blue light for placement and confirmation of retention.

The plug is made by Ocular Therapeutix, which sponsored the trials.

Internal server error