Posurdex steroid-release implant effective in phase 2 trials

ANAHEIM, Calif. — The Posurdex dexamethasone implant from Oculex Pharmaceuticals was effective in improving visual acuity and reducing signs of macular edema in a phase 2 trial, according to a surgeon speaking here.

Julia A. Haller, MD, presented the outcomes of a 306-patient study of Posurdex at the retinal subspecialty day prior to the American Academy of Ophthalmology meeting.

In the study, 172 patients with diabetic macular edema, 103 patients with branch retinal vein occlusion or central retinal vein occlusion, 27 patients with Irvine-Glass syndrome and 14 patients with uveitic macular edema were randomized to one of two dosages of the Posurdex dexamethasone implant. The implants were inserted directly into the posterior segment. They continuously released dexamethasone for 35 days before biodegrading in the eye.

Patients received either a single intravitreal Posurdex implant containing 350 µg of dexamethasone, an implant containing 700 µg of dexamethasone, or observation with no medication.

Ninety days after implantation, patients who received 700 µg of dexamethasone had a statistically significant improvement in visual acuity of 2 lines or more (P = .019) compared to patients who received no drug therapy. Patients implanted with 350 µg of dexamethasone showed a trend toward visual acuity improvement, indicating a dose response to the therapy, Dr. Haller said.

Improvement in macular edema was marked by significant decreases in retinal thickness and fluorescein leakage (P < .001) in the large dosage group, and in the smaller dosage group (retinal thickness: P =.015, fluorescein leakage: P = .002). An elevation of intraocular pressure, noted in 32 study eyes, was controlled with topical antiglaucoma medications.

Phase 3 trials for the Posurdex implant are currently under way, Dr. Haller said.