Allergan announced the U.S. FDA has approved Durysta (bimatoprost implant) 10 mcg for intracameral administration. Durysta is the first intracameral, biodegradable sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
FDA approval was 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 studies, Durysta reduced IOP by approximately 30 percent from baseline over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator.
In controlled studies, the most common ocular adverse reaction reported by 27% of patients was conjunctival hyperemia. Other common adverse reactions reported in 5%-10% of patients were foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, intraocular pressure increased, corneal endothelial cell loss, vision blurred, iritis, and headache.
Durysta is a prostaglandin analog indicated for the reduction of IOP in patients with OAG or OHT.
Durysta is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant containing 10 mcg bimatoprost. Durysta is preloaded into a single-use applicator to facilitate the administration of the biodegradable implant directly into the anterior chamber of the eye.
Glaucoma is one of the primary causes of irreversible vision loss and blindness. An estimated 70 million people globally are living with glaucoma. This progressive disease is characterized by elevated IOP. Uncontrolled, elevated IOP causes damage to the optic nerve and loss of vision. Reduction of elevated IOP is the only proven way to slow the progression of vision loss associated with glaucoma.
Current treatments to lower IOP include topical medications (eye drops), laser trabeculoplasty, minimally invasive glaucoma surgery and incisional surgery. Eye drop medications are a standard first-line treatment for open-angle glaucoma, the most common form, but low patient adherence to these medications is common – up to 80 percent of patients are not using topical medications as prescribed. Poor adherence to glaucoma medication could result in disease progression and vision loss.