Allergan Receives FDA Approval for DURYSTA™ (bimatoprost implant) the First and Only Intracameral Biodegradable Sustained-Release Implant to lower Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension Patients
- DURYSTA™ lowered intraocular pressure in patients with open-angle glaucoma or ocular hypertension by approximately 30 percent from baseline in two Phase 3 studies -
- Allergan continues five ongoing Phase 3 studies with DURYSTA™ to support further potential FDA label enhancement and rest of the world approvals -
DUBLIN, March 5, 2020 -- 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.
About Allergan Eye Care
As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the industry for more than 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in new treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion. Our eye care pipeline includes 13 additional agents for multiple ocular conditions.
Our commitment to the well-being of patients is also reflected in social responsibility. Allergan, The Allergan Foundation and The Allergan International Foundation support more than 150 organizations around the world working to improve lives and communities. We remain steadfast in helping eye care providers deliver the best in patient care through innovative products and outreach programs.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
Manisha Narasimhan, PhD