This article is more than 5 years old. Information may no longer be current.
Study: Bimatoprost sustained-release implant maintains IOP lowering up to 24 weeks
Click Here to Manage Email Alerts
FORT LAUDERDALE, Fla. — At all dose strengths, a bimatoprost sustained-release implant was well tolerated and comparable to topical bimatoprost in overall IOP reduction, according to 6-month interim results of a phase 1/2 study.
“We need something better than eye drops, so we’re all looking for that right way to lower pressure with a sustained delivery device,” E. Randy Craven, MD, said at the American Glaucoma Society meeting.
E. Randy Craven
The Bimatoprost SR (Allergan) biodegradable implant is delivered intracamerally via a prefilled single-use applicator and releases drug slowly over 4 to 6 months.
“Our study objective was to look at, how effective was this sustained-release device in lowering intraocular pressure and how safe is it?” Craven said.
In this study, 75 glaucomatous patients received one of four doses — 6 µg, 10 µg, 15 µg or 20 µg — in one eye and topical bimatoprost 0.03% therapy in the fellow eye. The primary endpoint was change in IOP from baseline.
More pressure reduction was seen initially with the 20 µg dose, but by 16 weeks, the dose response for all the doses was “pretty much the same,” Craven said, with those similar effects still apparent at 24 weeks.
“Between 12 and 16 weeks, the pressure reduction is maintained for the vast abundance of patients who have this implanted,” Craven said in regard to the need for re-dosing. However, by 20 weeks, maintaining the pressure reduction is “less likely.”
Pressure reduction on the average over 16 weeks for the 10 µg and 15 µg groups was similar to the pressure reduction for the drops, that is, 7.4 mm Hg, 8.1 mm Hg and 8.4 mm Hg, respectively.
Most ocular adverse events were associated with the injection, with incidence of hyperemia diminishing beyond 2 days after the injection, he said.
“Overall, it seems to be very well tolerated in the long run,” Craven said. – by Patricia Nale, ELS
Reference:
Craven ER. Interim 6-month results from a phase 1/2 clinical trial of bimatoprost sustained-release implant: IOP lowering, safety, and patient-reported outcomes. Presented at: American Glaucoma Society 26th annual meeting; March 3-6, 2016; Fort Lauderdale, Fla.
Disclosure: Allergan is the study sponsor. Craven reports he is a consultant to and has received lecture fees from Alcon and Allergan, has received grant support from Allergan, Ivantis and Transcend Medical, and is a consultant to Pfizer.