In this section, you will find downloadable educational materials to optimize the OZURDEX® injection procedure for you and your patients. You will also find helpful links, as well as information on recommended patient follow-up.

Precision Program
injector resources
Patient
follow-up
Download
patient guides
Helpful links

PRECISION PROGRAM

Injector resources and education

The Precision Program provides helpful tools, training, and patient-education materials.
Click the icons below to access these resources.

On-demand injection technique video
An essential resource for new injectors of OZURDEX® intravitreal implants, this brief video highlights important information for the clinician and provides details of the optimal injection technique.

Companion injection technique brochure
A convenient quick-reference guide designed to complement the Injection Technique Video.

Downloadable patient guides
Important information to help prepare patients for OZURDEX® treatment—before, during, and after injection.

OZURDEX® Ordering and Support Hotline reference card
A handy guide for using the Hotline, 1-866-OZURDEX (698-7339), to:
  • Order OZURDEX®
  • Connect to ARCC reimbursement services
  • Connect to the OZURDEX PATIENT ASSISTANCE® Program
  • Connect to the Allergan Medical Information Department

Recommended patient follow-up

Patients should be monitored regularly for elevation in intraocular pressure and for endophthalmitis1

Monitoring may consist of the following:
  • Perfusion check of the optic nerve head immediately after injection
  • Tonometry within 30 minutes following the injection
  • Biomicroscopy between 2 and 7 days following the injection
Patients should be counseled regarding the risk of potential complications, particularly, but not limited to, endophthalmitis and elevated intraocular pressure:
  • Inform patients of the need to be vigilant for symptoms in the days following intravitreal injection
  • Stress the importance of seeking immediate care from an ophthalmologist if the eye becomes red, sensitive to light, painful, or develops a change in vision
  • Advise patients that a cataract may occur after repeated treatment with OZURDEX®. If this occurs, advise patients that their vision will decrease, and they will need an operation to remove the cataract and restore their vision.
  • Advise patients that they may develop increased intraocular pressure with OZURDEX® treatment, and the increased IOP will need to be managed with eye drops, and, rarely, with surgery.
  • Also advise patients that they may experience temporary visual blurring after receiving an intravitreal injection. Patients should not drive or use machines until the blurring has resolved

Reference:
1. OZURDEX® Prescribing Information.

Patient guides

These informative, patient-friendly education booklets cover important topics to help maximize the success of injection procedures

  • Structure and function of the healthy eye
  • Diabetic macular edema, retinal vein occlusion, or noninfectious posterior segment uveitis
  • Benefits and risks of treatment with OZURDEX® intravitreal implants
  • The injection procedure: before, during, and after
  • Patients can download the guides directly from the OZURDEX® patient site
    • You can also download them to use in your practice

Helpful websites

Retina resources

You may use the web addresses below to visit leading professional organizations in retinal medicine. Allergan accepts no responsibility for the content of these sites. Allergan does not endorse nor control these sites, and the opinions, claims, or comments expressed on these sites should not be attributed to Allergan.

Professional associations

To visit these medical societies online, cut and paste the web addresses into your browser.

American Academy of Ophthalmology www.aao.org
American Society of Retina Specialists www.asrs.org
The Association for Research in Vision and Ophthalmology www.arvo.org
The Macula Society www.maculasociety.org
The Retina Society www.retinasociety.org

Indications and Usage
Diabetic Macular Edema
OZURDEX® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment of diabetic macular edema.

Retinal Vein Occlusion
OZURDEX® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Posterior Segment Uveitis
OZURDEX® is indicated for the treatment of noninfectious uveitis affecting the posterior segment of the eye.

IMPORTANT SAFETY INFORMATION
Contraindications

Ocular or Periocular Infections: OZURDEX® (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

Glaucoma: OZURDEX® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.

Torn or Ruptured Posterior Lens Capsule: OZURDEX® is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX® use.

IMPORTANT SAFETY INFORMATION
Contraindications

Ocular or Periocular Infections: OZURDEX® (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

IMPORTANT SAFETY INFORMATION
Contraindications

Ocular or Periocular Infections: OZURDEX® (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

Glaucoma: OZURDEX® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.

Torn or Ruptured Posterior Lens Capsule: OZURDEX® is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX® use.

Hypersensitivity: OZURDEX® is contraindicated in patients with known hypersensitivity to any components of this product.

Warnings and Precautions
Intravitreal Injection-related Effects: Intravitreal injections, including those with OZURDEX®, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly following the injection.

Steroid-related Effects: Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.

See more below

IMPORTANT SAFETY INFORMATION (continued)
Contraindications (continued)

Glaucoma: OZURDEX® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.

Torn or Ruptured Posterior Lens Capsule: OZURDEX® is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX® use.

Hypersensitivity: OZURDEX® is contraindicated in patients with known hypersensitivity to any components of this product.

Warnings and Precautions
Intravitreal Injection-related Effects: Intravitreal injections, including those with OZURDEX®, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly following the injection.

Steroid-related Effects: Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.

Adverse Reactions
Diabetic Macular Edema
Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following injection of OZURDEX® for diabetic macular edema include: cataract (68%), conjunctival hemorrhage (23%), visual acuity reduced (9%), conjunctivitis (6%), vitreous floaters (5%), conjunctival edema (5%), dry eye (5%), vitreous detachment (4%), vitreous opacities (3%), retinal aneurysm (3%), foreign body sensation (2%), corneal erosion (2%), keratitis (2%), anterior chamber inflammation (2%), retinal tear (2%), eyelid ptosis (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include: hypertension (13%) and bronchitis (5%).

Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 28% of OZURDEX® patients versus 4% of sham patients. 42% of the patients who received OZURDEX® were subsequently treated with IOP-lowering medications during the study versus 10% of sham patients.

The increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles (at the end of the 6-month period).

Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was higher in the OZURDEX® group (68%) compared with Sham (21%). The median time of cataract being reported as an adverse event was approximately 15 months in the OZURDEX® group and 12 months in the Sham group. Among these patients, 61% of OZURDEX® subjects versus 8% of sham-controlled subjects underwent cataract surgery, generally between Month 18 and Month 39 (Median Month 21 for OZURDEX® group and 20 for Sham) of the studies.

Retinal Vein Occlusion and Posterior Segment Uveitis
Adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX® for retinal vein occlusion and posterior segment uveitis include: intraocular pressure increased (25%), conjunctival hemorrhage (22%), eye pain (8%), conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous detachment (2%), and headache (4%).

Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received OZURDEX® required surgical procedures for management of elevated IOP.

Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION. The intravitreal injection procedure should be carried out under controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

Please click here for full Prescribing Information.