Implant helps reduce macular edema, diabetic retinopathy, study shows

ROCHESTER, N.Y. — A retinal implant reduced diabetic macular edema and the severity of diabetic retinopathy, according to results of a phase 3 trial.

The implant is a small drug reservoir implanted into the back of the eye. Researchers at Bausch & Lomb, developer of the Envision TD implant, said the implant delivers fluocinolone acetonide directly to the affected area of the eye for up to 3 years.

In the multicenter trial, 80 patients were randomized to receive standard of care (macular grid laser or observation) or either a 0.5 mg or a 2 mg implant. The 2 mg dose was discontinued early in the diabetic macular edema trial because data did not suggest a therapeutic advantage for the 2-mg dose over the 0.5 mg dose.

Patients receiving the 0.5 mg implant showed statistically significant improvement in macular edema compared to those receiving standard of care (P = .03). The patients who received the implant showed a greater improvement in the severity of their diabetic retinopathy compared to those treated with standard of care. More than 80% of the patients with the implants also had improved or stable visual acuity, compared with 50% of those treated with standard of care.

The incidence of serious ocular adverse events was similar in both groups. Adverse events included cataracts, vitreous hemorrhage, retinal neovascularization and ocular hypertension. All were anticipated events because of the nature of the disease, researchers said.

The Food and Drug Administration has granted fast-track designation for the implant. Bausch & Lomb officials have said data from this trial, together with results of a second ongoing 6-month pivotal trial, will serve as the basis for a new drug application expected to be filed in 2003. The second trial will include about 180 patients, and full enrollment is expected to be completed by the third quarter of this year.