Eyeworld Daily News

2020 EyeWorld Daily News Saturday

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Page 61 of 63

Brief Summary—Please see the DURYSTA ™ package insert for full Prescribing Information INDICATIONS AND USAGE DURYSTA ™ is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). CONTRAINDICATIONS DURYSTA ™ is contraindicated in patients with active or suspected ocular or periocular infections; corneal endothelial cell dystrophy; prior corneal transplantation, or endothelial cell transplants; absent or ruptured posterior lens capsule, due to the risk of implant migration into the posterior segment; or hypersensitivity to bimatoprost or any other components of the product. WARNINGS AND PRECAUTIONS Corneal Adverse Reactions: 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. Iridocorneal Angle: Following administration with DURYSTA ™ , the intracameral implant is intended to settle within the inferior angle. 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: 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. Intraocular Inflammation: 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. Pigmentation: 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. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. While treatment with DURYSTA ™ can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Endophthalmitis: 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. ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common ocular adverse reaction observed in two randomized, active-controlled clinical trials with DURYSTA ™ in patients with OAG or OHT was conjunctival hyperemia, which was reported in 27% of patients. Other common ocular 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, and iritis. Ocular adverse reactions occurring in 1-5% of patients were anterior chamber cell, lacrimation increased, corneal edema, aqueous humor leakage, iris adhesions, ocular discomfort, corneal touch, iris hyperpigmentation, anterior chamber flare, anterior chamber inflammation, and macular edema. The following additional adverse drug reactions occurred in less than 1% of patients: hyphema, iridocyclitis, uveitis, corneal opacity, product administered at inappropriate site, corneal decompensation, cystoid macular edema, and drug hypersensitivity. The most common nonocular adverse reaction was headache, which was observed in 5% of patients. USE IN SPECIFIC POPULATIONS Pregnancy: There are no adequate and well-controlled studies of DURYSTA ™ administration in pregnant women to inform a drug associated risk. Oral administration of bimatoprost to pregnant rats and mice throughout organogenesis did not produce adverse maternal or fetal effects at clinically relevant exposures. Oral administration of bimatoprost to rats from the start of organogenesis to the end of lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant exposures. In embryo/fetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of bimatoprost which achieved at least 1770 times the maximum human bimatoprost exposure following a single administration of DURYSTA ™ (based on plasma C max levels; blood-to-plasma partition ratio of 0.858). In a pre/postnatal development study, oral administration of bimatoprost to pregnant rats from gestation day 7 through lactation resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at 0.3 mg/kg/day (estimated 470-times the human systemic exposure to bimatoprost from DURYSTA ™ , based plasma C max and a blood-to plasma partition ratio of 0.858). No adverse effects were observed in rat offspring at 0.1 mg/kg/day (estimated 350-times the human systemic exposure to bimatoprost from DURYSTA ™ , based on plasma C max ). Lactation: There is no information regarding the presence of bimatoprost in human milk, the effects on the breastfed infants, or the effects on milk production. In animal studies, topical bimatoprost has been shown to be excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when DURYSTA ™ is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for DURYSTA ™ and any potential adverse effects on the breastfed child from DURYSTA ™ . Pediatric Use: Safety and effectiveness of DURYSTA ™ in pediatric patients have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses up to 2 mg/kg/day and 1 mg/kg/day respectively for 104 weeks (approximately 3100 and 1700 times, respectively, the maximum human exposure [based on plasma C max levels; blood-to-plasma partition ratio of 0.858]). Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests. Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day (1770-times the maximum human exposure, based on plasma C max levels; blood-to-plasma partition ratio of 0.858). PATIENT COUNSELING INFORMATION Treatment-related Effects: Advise patients about the potential risk for complications including, but not limited to, the development of corneal adverse events, intraocular inflammation or endophthalmitis. Potential for Pigmentation: Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. When to Seek Physician Advice: Advise patients that if the eye becomes red, sensitive to light, painful, or develops a change in vision, they should seek immediate care from an ophthalmologist. Rx only © 2020 Allergan. All rights reserved. DURYSTA ™ is a trademark of Allergan, Inc. Patented. See: www.allergan.com/patents DUR133688 03/20 based on v1.0USPI9652

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