Allergan’s Durysta is the first intracameral, biodegradable sustained-release implant shown to reduce intra ocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Recently approved by the US Federal Drug Administration (FDA), the Durysta (bimatoprost implant) 10mcg for intracameral administration demonstrated a reduction in IOP by approximately 30% from baseline over a 12-week primary efficacy period, meeting the predefined criteria for noninferiority to the study comparator.
“If you look at the patient population in glaucoma, 27% of patients have some sort of comorbidity, being mental or physical, that could potentially [cause them to] not be able to administer a drug every single day or on a regular basis,” Allergan’s vice president, Ramin Valian told Eyewire.
“At the same time, with glaucoma being a progressive disease, what is clear is that most glaucoma patients continue to advance even with existing therapies being dropped for other interventions such as SLT or other types of interventions such as MIGS. Patients continue to progress and Durysta fits that paradigm,” Valian said.
The two 20-month Artemis phase III clinical studies, including eight months extended follow up, evaluated 1122 subjects on the efficacy and safety of Durysta vs twice daily topical timolol drops, an FDA accepted drug for comparison in registrational clinical trials in patients with OAG or OHT.
Allergan’s Durysta is scheduled to be commercially available in the second quarter of this year.