Bimatroprost SR represents a paradigm shift in glaucoma treatment
This article was reviewed by Felipe Medeiros, MD, PhD
With the FDA approval earlier this month of a new drug application (NDA) for the bimatoprost implant (Durysta, Allergan) 10 mcg for intracameral administration, the bimatoprost implant becomes the first intracameral, biodegradable, sustained-release (SR) implant indicated to reduce IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT), according to the company.
Leading up to this approval, the bimatoprost SR implant met the primary endpoint of the ARTEMIS phase III study. It lowered IOP by about 30% and was found to be noninferior to timolol for reducing IOP through 12 weeks.
In extended follow-up, more than three-quarters of eyes did not require additional treatment for one year following three administrations of the drug.
In the ARTEMIS phase III trials, patients were randomly assigned to treatment with bimatoprost SR versus timolol. Two concentrations of bimatoprost were evaluated, 10 and 15 mcg.
The focus of the results reporting was on the lower dose, which will be the one that will be commercially available. Eyes randomly assigned to bimatoprost SR received implants every four months, for a total of three implants of the drug over the course of one year.
“Eighty percent of the eyes that received the three implants of bimatoprost SR had sustained IOP control for one year, without the need for additional treatment,” said Felipe Medeiros, MD, PhD, distinguished professor of ophthalmology and the Joseph Wadsworth Endowed Chair, Duke University, Durham, NC. “We currently believe that the higher concentration of the drug achieved at the target tissues, such as the ciliary body, may lead to greater expression of matrix metalloproteinases and more extensive extracellular tissue remodeling, potentially explaining the long-term effects in reducing IOP.”
In addition, visual field data indicated that the eyes treated with the 10-µg dose of bimatoprost SR had less glaucomatous progression of the visual fields over time.