B&L to delay FDA application for diabetic edema implant

FORT LAUDERDALE, Fla. — Bausch & Lomb will delay filing for regulatory approval of its Retisert implant by up to 3 years, according to a company announcement.

The implant, which is being evaluated for treatment of diabetic macular edema, is designed to provide intraocular sustained release of fluocinolone acetonide for up to 3 years.

According to Bausch & Lomb, the delay in filing of the new drug application (NDA) follows discussions with the Food and Drug Administration, which wants to see 12-month safety data for more patients before reviewing the implant. Both B&L and Control Delivery Systems, codeveloper of the implant, will assess the impact of the delay when 12-month data from a second phase 3 trial is completed later this year.

Results of 12-month data from the first phase 3 randomized, controlled, masked clinical trial were presented here at the annual Association for Research in Vision and Ophthalmology meeting. P. Andrew Pearson, MD, chairman of the department of ophthalmology at the University of Kentucky Medical School and lead investigator in the trial presented the results.

In the trial, 80 patients were randomly assigned to one of three arms; 11 patients were included in the 2 mg implant group, 41 patients were included in the 0.5 mg implant group and 28 patients were assigned to receive standard of care (SOC), which was macular grid laser or observation. Enrollment in the 2 mg arm of the trial was discontinued early in the trial.

According to Dr. Pearson, 48.8% of patients treated with the 0.5 mg implant had resolution of macular edema, compared to 25% of patients receiving SOC. The difference between the groups was statistically significant (P < .05). This was the primary endpoint of the trial.

Secondary visual endpoints were also assessed, although the study was not designed or powered to demonstrate visual improvement. More patients in the 0.5 mg treatment arm experience visual improvement, and fewer experienced visual deterioration, than in the SOC arm. The differences were not statistically significant, however.

At 12 months, 58.5% of patients implanted with the 0.5 mg implant and 10.7% in SOC group experienced serious ocular adverse events in the study eye. Investigators noted that these events were anticipated because of the type of drug used and the nature of the disease. Serious increases in intraocular pressure were experienced by 19.5% of the 0.5 mg implant group and 0% of patients in the SOC group. Also, 54.8% of the patients in the 0.5 mg implant group and 0% of the patients in the SOC group who had not undergone cataract surgery before study enrollment experienced cataract progression.

According to B&L, patients in the trial will be followed for an additional 3 years as the safety of the implant continues to be evaluated.