■ In an earlier 75-patient phase 1/2 trial of the biodegradable sustained-release Bimatoprost SR implant conducted by Allergan, 28% of patients (n=19) went 24 months with a single implant without retreatment. The phenomenon was seen among all dose cohorts and was not dose dependent, said principal investigator Ike Ahmed, MD, from Prism Eye Institute in Toronto.
“The extended response was unexpected and is not explained by the drug itself, but it is fascinating,” said Dr. Ahmed. “The ability of the drug to reach 4,000 times concentration in the ciliary body by injecting it into the anterior segment is far beyond what can be done topically.”
Patients who went 24 months without retreatment shared the following characteristics: baseline IOP of less than 25, at least 5-year history of glaucoma, and previous treatment with a prostaglandin analog.
Bimatoprost SR has now advanced to 2 large pivotal phase 3 clinical trials with positive early data regarding long-term durability recently reported. Allergan expects to submit a new drug application to the FDA in the second half of 2019.