March 5, 2020: Allergan announced that the U.S. 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 intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
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 effectiveness and safety of DURYSTA™ versus twice-daily topical timolol drops, an FDA accepted comparator for the registrational clinical trials, in patients with OAG or OHT. In the two Phase 3 ARTEMIS studies, DURYSTA™ reduced IOP by about 30 percent from baseline over the 12-week primary value period, meeting the predefined criteria for non-inferiority to the study comparator. With the launch of DURYSTA™, Allergan proudly expands availability of the Allergan EyeCue®, a proven reimbursement service for the eye care professionals in order to facilitate patient benefit verification, savings program enrollment for eligible patients, and prior authorization (PA) assistance for Allergan Eye Care products.
About DURYSTA™DURYSTA™ is a prostaglandin analogue indicated for the reduction of IOP in the patients with OAG or OHT. DURYSTA™ is an ophthalmic drug delivery system for a single intracameral administration of the biodegradable implant containing 10 mcg bimatoprost. DURYSTA™ should not be re-administered to an eye that received a prior DURYSTA™. DURYSTA™ is preloaded into a single-use applicator to assist the administration of the biodegradable implant directly into the anterior chamber of the eye.
INDICATIONS AND USAGE: DURYSTA™ (bimatoprost implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
IMPORTANT SAFETY INFORMATION Contraindications: DURYSTATM is contraindicated in patients with: confirmed or suspected ocular or periocular infections; corneal endothelial dystrophy (e.g., Fuchs ‘ dystrophy); previous corneal transplantation or endothelial cell transplantation (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [ DSAEK ]); absent or ruptured posterior lens capsule, due to the risk of the implant migration into posterior segment; hypersensitivity to bimatoprost or to any other components of the product.
Warnings and Precautions: The presence of
DURYSTA™ implants has been associated with the corneal adverse reactions and
increased risk of the corneal endothelial cell loss. DURYSTATM administration
should be limited to one single implant per eye with no retreatment. Caution
should be taken in patients with limited corneal endothelial cell reserve when
prescribing DURYSTATM.Adverse reactions: In
controlled studies, 27 per cent of patients reported the most common ocular
adverse reaction being conjunctival hyperemia. Other common adverse reactions
included foreign body sensation, eye pain, photophobia, conjunctival
hemorrhage, dry eye irritation, increased intraocular pressure, corneal
endothelial cell loss, blurred vision, iritis, and headache in 5 per cent of
patients.
https://www.allergan.com/News/Details/2020/03/Allergan%20Receives%20FDA%20Approval%20for%20DURYSTA%20bimatoprost%20implant%20the%20First%20and%20Only%20Intracameral%20Biode
