Over a 12-week treatment period with Bimatoprost SR participants had an approximate 30% reduction in IOP.
A first-in-class implant reduced intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension by approximately 30%. The findings come from Phase 3 clinical study results of Bimatoprost SR, announced today by Allergan.
Bimatoprost SR is a investigative, sustained release, drop-free alternative therapy intended to lower eye pressure for glaucoma patients. The trial included 594 individuals with open-angle glaucoma or ocular hypertension. Participants were randomized to receive 3 administration cycles (Day 1, Week 16 and Week 32) of Bimatoprost SR or twice daily timolol eye drops. Vehicle eye drops or sham administrations (Day 1, Week 16 and Week 32) are used in the study eyes for masking purposes.
Over a 12-week treatment period with Bimatoprost SR participants had an approximate 30% reduction in IOP. Meeting the primary efficacy endpoint of non-inferiority to the comparator timolol.
Results from a second, identical Phase 3 study will be reported in early 2019, say the Company, which will precede a New Drug Application filing to the Food and Drug Administration (FDA) in the second half of 2019.
“This [Bimatoprost SR] is a real potential paradigm shift in our options to lower eye pressure in patients with glaucoma,” said Randy Craven, MD, Chief, Wilmer Eye Institute at Bethesda and Vice Chair of Wilmer Practice Network.