Durysta

DURYSTA^® (bimatoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

• For ophthalmic intracameral administration. (
  2.000000000000000e+00

  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 eye that received a prior DURYSTA.
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• The intracameral administration should be carried out under standard aseptic conditions. (
  2.2

  Administration

  The intracameral injection procedure must be performed under magnification that allows clear visualization of the anterior chamber structures and should be carried out using standard aseptic conditions for intracameral procedures, with the patient’s head in a stabilized position. The eye should not be dilated prior to the procedure.

  Remove the foil pouch from the carton and examine for damage. Then, open the foil pouch over a sterile field and gently drop the applicator on a sterile tray. Once the foil pouch is opened, use the applicator promptly.

  Figure 1

  

  Perform a detailed visual inspection of the applicator, including ensuring that the actuator button has not been depressed, and the safety tab is in place. Carefully remove the plastic safety cap taking care to avoid contacting the needle tip. Inspect the needle tip for damage under magnification prior to use; the implant retention plug may be visible in the bevel and should not be removed.

  Prior to use, remove the safety tab by pulling it out perpendicular to the long axis of the applicator (refer to Figure 1a above). Do not twist or bend the tab.

  Stabilize the eye as the needle is advanced through the cornea. Enter the anterior chamber with the needle bevel visible through clear cornea. Enter parallel to the iris plane, adjacent to the limbus through clear cornea in the superotemporal quadrant.

  The needle should be inserted approximately 2 bevel lengths with the bevel completely within the anterior chamber; avoid positioning the needle bevel directly over the pupil. Ensure the needle is not bent before depressing the actuator button. See Figure 2.

  Figure 2

  

  Depress the back half of the actuator button (refer to Figure 1b above) firmly until an audible and/or palpable click is noted.

  Following the release of the implant, remove the needle via the same track in which it was inserted and tamponade the opening. The implant should not be left in the corneal injection track.

  Check the injection site for leaks; make sure that it is self-sealing and the anterior chamber is formed.

  After injection,

  do not

  recap the needle. Dispose of the used applicator in a sharps disposal container and in accordance with local requirements.

  Instruct the patient to remain upright for at least 1 hour after the procedure so the implant can settle.

  Some degree of eye redness and discomfort is expected following administration. However, it is recommended to instruct patients that if the eye becomes progressively red, sensitive to light, painful, or develops a change in vision, they should immediately contact the physician.
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Intracameral implant containing 10 mcg of bimatoprost in a drug delivery system.

There are no adequate and well-controlled studies of DURYSTA (bimatoprost intracameral implant) 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 an embryofetal development rat study, oral administration of bimatoprost to pregnant rats during organogenesis produced abortion at 0.6 mg/kg/day (1770-times the human systemic exposure to bimatoprost from DURYSTA, based on C_max and a blood-to plasma partition ratio of 0.858). The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 470-times the human systemic exposure to bimatoprost from DURYSTA, based on C_max). No fetal abnormalities were observed at doses up to 0.6 mg/kg/day.

In an embryofetal development mouse study, oral administration of bimatoprost to pregnant mice during organogenesis produced abortion and early delivery at 0.3 mg/kg/day (2240-times the human systemic exposure to bimatoprost from DURYSTA, based on plasma C_max level; blood-to plasma partition ratio of 0.858). The NOAEL for abortion and early delivery was 0.1 mg/kg/day (400-times the human systemic exposure to bimatoprost from DURYSTA, based on C_max). No fetal abnormalities were observed at doses up to 0.6 mg/kg/day (5200-times the human systemic exposure to bimatoprost from DURYSTA, based on C_max).

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).

• Endothelial cell loss
  : Due to possible corneal endothelial cell loss, administration of DURYSTA should be limited to a single implant per eye without retreatment. (
  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 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.
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• Corneal Adverse Reactions
  : DURYSTA has been associated with corneal adverse reactions and risks are increased with multiple implants. Use caution in patients with limited corneal endothelial cell reserve. (
  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 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.
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• Iridocorneal Angle
  : DURYSTA should be used with caution in patients with narrow angles or anatomical angle obstruction. (
  5.2

  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.
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