Intravitreal implant with brimonidine reduced GA lesion growth in phase 2 study

ByBaruch D. Kuppermann, MD, PhD

BALTIMORE — A brimonidine drug delivery system was well tolerated and reduced geographic atrophy lesion growth, nearing statistical significance at year 2 with a higher dose, based on a phase 2, multicenter, double-masked study presented at the Association for Research in Vision and Ophthalmology annual meeting.

“In the AMD arena where there is a dire need and no treatments for geographic atrophy available, this is showing some signs of promise in a drug that we’ve had our hands on for over a decade,” Baruch D. Kuppermann, MD, PhD, said in an interview with Healio.com/OSN.

In the study, 113 patients with bilateral geographic atrophy (GA) secondary to age-related macular degeneration were randomized 2:2:1 to the Brimonidine Drug Delivery System (Brimo DDS, Allergan) 132 µg, Brimo DDS 264 µg or sham in the treated eye at baseline and 6 months, with follow-up through 24 months.

GA change from baseline was consistently lower in both Brimo DDS groups vs. the sham group and was significantly smaller with brimonidine 132 µg and 264 µg vs. sham at 3 months, according to the researchers.

Brimo DDS is an intravitreal implant with brimonidine in a slow-release matrix. “It’s a biodegradable pellet. The drug releases and the polymer biodegrades, so the entire drug delivery system disappears entirely,” Kuppermann said.

Researchers confirmed that Brimo DDS reduced the rate of progression at 1 year via a sensitivity analysis and a mixed model repeated measure analysis with covariate of baseline GA lesion area.

At 2 years, there was reduced lesion growth in the Brimo DDS 265 µg group.

Treatment-related ocular events were reported in 35%, 28% and 9% of patients in the 132 µg, 265 µg and sham groups, respectively, with most related to the injection procedure.

“When we looked at the data in this way, you can see the sham group and treatment effect very clearly. There’s a 30% reduction in growth in lesion size, which is quite significant,” Kuppermann said.

A phase 2b study is ongoing. – by Abigail Sutton

Reference:

Kuppermann BD, et al. Brimonidine drug delivery system generation 1 in patients with geographic atrophy: Post hoc analysis of a phase 2 study. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 7-11, 2017; Baltimore.

Disclosure: Kuppermann reports he has received financial support from Alcon, Allergan, Apellis, Genentech, GSK, Ophthotech and Regeneron and is a consultant for Alcon, Allergan, Catalyst, Genentech, Novartis and Ophthotech. Please see the study for all other authors’ relevant financial disclosures.