Label: DURYSTA- bimatoprost implant

  • NDC Code(s): 0023-9652-01, 0023-9652-03
  • Packager: Allergan, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 16, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DURYSTA safely and effectively. See full prescribing information for DURYSTA.     DURYSTA® (bimatoprost intracameral implant) ...
  • Table of Contents
    Table of Contents
  • 1       INDICATIONS AND USAGE
    DURYSTA® (bimatoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
  • 2       DOSAGE AND ADMINISTRATION
    2.1 -       General Information - DURYSTA is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant. DURYSTA should not be readministered to an ...
  • 3       DOSAGE FORMS AND STRENGTHS
    Intracameral implant containing 10 mcg of bimatoprost in a drug delivery system.
  • 4       CONTRAINDICATIONS
    4.1 -       Ocular or Periocular Infections - DURYSTA is contraindicated in patients with active or suspected ocular or periocular infections. 4.2 -       Corneal Endothelial Cell ...
  • 5       WARNINGS AND PRECAUTIONS
    5.1 -       Corneal Adverse Reactions - The presence of DURYSTA implants has been associated with corneal adverse reactions and increased risk of corneal endothelial cell loss. Administration ...
  • 6       ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in labeling: Implant migration [see Contraindications (4.4)] Hypersensitivity [see Contraindications ...
  • 8       USE IN SPECIFIC POPULATIONS
    8.1 -       Pregnancy - Risk Summary - There are no adequate and well-controlled studies of DURYSTA (bimatoprost intracameral implant) administration in pregnant women to inform a drug ...
  • 11       DESCRIPTION
    DURYSTA is a sterile intracameral implant containing 10 mcg of bimatoprost, a prostaglandin analog, in a solid polymer sustained-release drug delivery system (DDS). The drug delivery system ...
  • 12       CLINICAL PHARMACOLOGY
    12.1 -       Mechanism of Action - Bimatoprost, a prostaglandin analog, is a synthetic structural analog of prostaglandin with ocular hypotensive activity. Bimatoprost is believed to lower IOP ...
  • 13       NONCLINICAL TOXICOLOGY
    13.1 -       Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses up to ...
  • 14       CLINICAL STUDIES
    Efficacy was evaluated in two multicenter, randomized, parallel-group, controlled 20-month (including 8-month extended follow-up) studies of DURYSTA compared to twice daily topical timolol 0.5 ...
  • 16       HOW SUPPLIED/STORAGE AND HANDLING
    DURYSTA contains a 10 mcg bimatoprost intracameral implant in a single-use applicator that is packaged in a sealed foil pouch containing desiccant, NDC 0023-9652-01. Storage - Store refrigerated ...
  • 17       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 ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0023-9652-01 - DURYSTA®  (bimatoprost intracameral implant) 10 mcg - One Sterile, Single-Dose Applicator - For Intracameral administration - Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information