Dexamethasone insert 0.4 mg (Dextenza Ocular Therapeutix) met its primary endpoints in a third pivotal trial investigating its efficacy and safety for the treatment of inflammation and pain after cataract surgery, said Eric D. Donnenfeld, MD.
Presenting data from the prospective, multicenter, randomized, double-masked phase III study, Dr. Donnenfeld said he was excited about the results because he anticipates they will support FDA approval of the intracanalicular insert in the near future.
“Corticosteroids are a mainstay of cataract surgery medication regimens, but topical regimens are complex, depend on patient compliance, and have the potential to cause ocular surface toxicity at a time when the eye is particularly vulnerable,” said Dr. Donnenfeld, clinical professor of ophthalmology, NYU Langone Medical Center, New York. “The development of alternatives to topical treatment is what it is all about.”
Dr. Donnenfeld also presented positive results from a phase III study investigating another investigational one-time corticosteroid medication, IBI-10090 (Dexycu, Icon Bioscience). IBI-10090 is a novel, bioabsorbable drug-delivery product for anterior chamber intracameral placement of dexamethasone. It is given as a single 5 µL injection after the completion of cataract surgery.
The study Dr. Donnenfeld presented showed IBI-100090 demonstrated similar efficacy and safety compared with “standard of care”—topical prednisolone acetate 1.0% four times daily as standard of care.