Phase II results of ForSight Vision5’s bimatoprost ocular ring insert have shown the ring achieves clinically significant reductions in intraocular pressure (IOP) over six months with an acceptable level of safety and tolerability, principal investigator James D. Brandt, MD, reported at OIS@ASCRS.
The results were just published online in the journal Ophthalmology. The bimatoprost ring is a flexible, ring-shaped device that is placed under the upper lid into the fornix and then under the lower lid and left in place to release clinically effective concentrations of the agent over six months, Dr. Brandt said.
Of course, medication compliance is a common conundrum with glaucoma patients. Dr. Brandt said the medical literature suggests that more than 1 million glaucoma patients do not adhere to their prescribed drops regimens.
With the bimatoprost ring, ForSight Vision5 is focusing on early-stage glaucoma. Of more than 300 patients who participated in Phase I and II trials, 90% or more have said the ring is comfortable while it achieves IOP lowering averaging 4 to 6 mm Hg over six months. The Ophthalmology study showed 88.5% of patients retained the rings without assistance for six months, and adverse events were in line with bimatoprost or timolol exposure. Dr. Brandt said the FDA has provided “clear guidance” for the Phase III study.
“We are also excited about the opportunity to use the ring platform for other indications,” Dr. Brandt said. The insert has “sufficient volume” for two or more drugs to be loaded onto the ring, he said, and ForSight is currently conducting a Phase I trial of a ring containing a fixed combination of bimatoprost and timolol.
James Brandt, MD
Dr. Brandt is Professor & Vice-Chair of Ophthalmology & Vision Science at the University of California, Davis. Dr. Brandt’s clinical practice is limited to glaucoma, with a particular focus on childhood glaucoma.