Allergan announced that the FDA has approved the company’s new drug application (NDA) for Durysta (bimatoprost implant) 10 mcg for intracameral administration. With this approval, Durysta becomes the first intracameral, biodegradable sustained-release implant indicated to reduce IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
To learn more about Durysta and what makes it different from existing glaucoma therapies, Eyewire News spoke with Ramin Valian, Allergan’s Vice President, Interventional Glaucoma.
“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,” Mr. Valian said. “And then at the same time, 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.”
The FDA approval is based on results from the two 20-month (including 8-month extended follow up) phase 3 ARTEMIS studies evaluating 1,122 subjects on the efficacy and safety of Durysta versus twice daily topical timolol drops, an FDA accepted comparator for registrational clinical trials, in patients with OAG or OHT. In the two phase 3 ARTEMIS studies, Durysta reduced IOP by approximately 30 percent from baseline over the 12-week primary efficacy period, meeting the predefined criteria for noninferiority to the study comparator.
“Today’s FDA approval marks a breakthrough milestone for the glaucoma community and provides a much-needed option for patients challenged with topical drops or needing alternative options,” David Nicholson, Chief Research and Development Officer, Allergan, said in a company news release. “At Allergan, our mission is to contribute meaningful strategies that help preserve people’s vision, while ensuring that therapies are mindful of the realities of administration and compliance.”
Durysta is currently indicated as a single-use implant, and patients who receive thee implant would not be able to be re-administered a second time. Allergan is conducting five ongoing phase 3 studies with Durysta to support further potential FDA label enhancements, including allowing for different dosing schedules and re-administration.
Allergan said that Durysta will be commercially available in the second quarter of this year.
With the launch of Durysta, Allergan expands availability of Allergan EyeCue, a reimbursement service for eye care professionals to facilitate patient benefit verification, savings program enrollment for eligible patients, and prior authorization (PA) assistance for Allergan eye care products.