FDA Approves Durysta (bimatoprost implant) to Lower Intraocular Pressure In Open-Angle Glaucoma or Ocular Hypertension Patients
DUBLIN, March 5, 2020 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company with more than 70 years of heritage in eye care, today announced that the U.S. Food and Drug Administration (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).
"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," said David Nicholson, Chief Research and Development Officer, Allergan. "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. As a commitment to the ongoing development of this innovation, Allergan has five ongoing Phase 3 studies with Durysta to support further potential FDA label enhancement and rest of the world approvals."
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 non-inferiority to the study comparator.
"Millions of people are living with glaucoma, one of the leading causes of vision loss; however, new treatment options are needed to help doctors and patients better manage this disease," said Felipe Medeiros , M.D., Ph.D., Distinguished Professor of Ophthalmology and Vice-Chair for Technology, Director Clinical Research Unit, Department of Ophthalmology, Duke University. "The ARTEMIS trials demonstrated that Durysta lowered IOP in patients by approximately 30 percent and demonstrated a duration of effect through the 12-week primary efficacy period. As the first FDA-approved intracameral, biodegradable sustained-release implant providing continuous drug delivery, Durysta has the potential to significantly shift the paradigm for treating glaucoma."
With the launch of Durysta, Allergan proudly expands availability of Allergan EyeCue®, a proven 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.
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 should not be re-administered to an eye that received a prior Durysta. Durysta is preloaded into a single-use applicator to facilitate 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
Durysta is contraindicated in patients with: active or suspected ocular or periocular infections; corneal endothelial cell dystrophy (e.g., Fuchs' Dystrophy); prior corneal transplantation or endothelial cell transplants (e.g., Descemet's Stripping Automated Endothelial Keratoplasty [DSAEK]); absent or ruptured posterior lens capsule, due to the risk of implant migration into the 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 corneal adverse reactions and increased risk of corneal endothelial cell loss. Administration of Durysta should be limited to a single implant per eye without retreatment. Caution should be used when prescribing Durysta in patients with limited corneal endothelial cell reserve.
Durysta should be used with caution in patients with narrow iridocorneal angles (Shaffer grade ˂ 3) or anatomical obstruction (e.g., scarring) that may prohibit settling in the inferior angle.
Macular edema, including cystoid macular edema, has been reported during treatment with ophthalmic bimatoprost, including Durysta intracameral implant. Durysta should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Prostaglandin analogs, including Durysta, have been reported to cause intraocular inflammation. Durysta should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Ophthalmic bimatoprost, including Durysta intracameral implant, has been reported to cause changes to pigmented tissues, such as increased pigmentation of the iris. Pigmentation of the iris is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. While treatment with Durysta can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
Intraocular surgical procedures and injections have been associated with endophthalmitis. Proper aseptic technique must always be used with administering Durysta, and patients should be monitored following the administration.
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.
Please see link to full prescribing information
For more information about DURYSTA, visit www.DURYSTAhcp.com
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. (Article from : www.drugs.com)