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DIABETIC
MACULAR EDEMA RETINAL
VEIN OCCLUSION NONINFECTIOUS POSTERIOR
SEGMENT UVEITIS PRACTICE
RESOURCES REIMBURSEMENT
SUPPORT ORDER
OZURDEX®
Pathophysiology  |  Epidemiology and Diagnosis  |  Delivery Technology  |  Mechanism of Action  |  3-year Clinical Efficacy  |  Case Studies
Safety Information  |  IOP and IOP Management  |  Dosing and Administration
Pathophysiology  |  Epidemiology and Diagnosis  |  Delivery Technology  |  Mechanism of Action  |  Clinical Efficacy  |  Case Studies
Safety Information  |  Dosing & Administration
Epidemiology and Diagnosis  |  Delivery Technology  |  Clinical Efficacy  |  Case Studies  |  Safety Information  |  Dosing & Administration

RVO is the second most common cause of visual loss due to retinal vascular disease.1,2

Two major types1:
  • Branch retinal vein occlusion (BRVO)
  • Central retinal vein occlusion (CRVO)

BRVO is the most common.3

Both types of RVO can lead to persistent macular edema.1

BRVO
epidemiology
BRVO diagnostic
criteria
CRVO
epidemiology
CRVO diagnostic
criteria

Incidence3

  • 5-year incidence of 0.6%
    • Population-based study of 4926 patients in Beaver Dam, Wisconsin; evaluated at baseline (1988-1990) and at 5-year follow-up (1993-1995)

Common risk factors4,5

  • Hypertension
  • Atherosclerotic conditions
  • Inflammatory conditions
  • Thrombophilic conditions

Potential complications4,6

  • Macular edema
  • Neovascularization
  • Epiretinal membrane
  • Vitreous hemorrhage
  • Retinal detachment

Potential impact of untreated BRVO7

While 50% to 60% of BRVO patients may regain eyesight of 20/40 or better over time:
  • In 20% to 25% of patients, final visual acuity may be 20/200 or worse
  • In the remainder of patients, final visual acuity may be between 20/50 and 20/100

Symptoms

  • Sudden painless vision loss is typical,4 but vision loss also may occur gradually over a period of days to weeks8

Diagnosis

  • Suspect BRVO in patients with painless vision loss, especially if risk factors are present4,5
  • Fluorescein angiography and optical coherence tomography may be used in diagnosis9
  • Fundoscopy confirms the diagnosis in the acute phase, typically revealing flame-shaped intraretinal hemorrhages, retinal edema, and cotton wool spots in the distribution of a vessel4
  • In the chronic phase, hemorrhages may be absent and macular edema may be the only sign4

Incidence3

  • 5-year incidence of 0.2%
    • Population-based study of 4926 patients in Beaver Dam, Wisconsin; evaluated at baseline (1988-1990) and at 5-year follow-up (1993-1995)

Common risk factors10

  • Hypertension
  • Age
  • Glaucoma
  • Diabetes
  • Increased blood viscosity

Potential complications10,11

  • Macular edema
  • Anterior segment neovascularization may lead to neovascular glaucoma weeks to months after occlusion
  • Retinal neovascularization may lead to vitreous hemorrhage

Potential impact of untreated CRVO

  • Most patients will have some visual deficit9
  • Nonischemic CRVO: In about 50% of patients, final visual acuity may be 20/200 or worse11
    • One-third of patients may progress to ischemic CRVO11
  • Ischemic CRVO: In more than 90% of patients, final visual acuity may be 20/200 or worse11
    • Approximately 60% of patients develop complications due to ocular neovascularization11
    • Complications have been described as “devastating”11

Symptoms

  • Sudden painless vision loss is typical, but vision loss also may occur gradually over a period of days to weeks8,9

Diagnosis

  • Suspect central retinal vein occlusion in patients with painless vision loss, especially if risk factors are present10
  • Fundoscopy confirms the diagnosis, often revealing widespread retinal hemorrhages, venous engorgement and tortuousness, cotton wool spots, macular edema, and optic disc edema10,11
  • Fluorescein angiography and ocular coherence tomography (OCT) may also be used in diagnosis12
  • Diagnostic workup should include evaluation for hypertension, glaucoma, and diabetes10
  • Young patients should also be tested for increased blood viscosity10

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.

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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.

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.

© 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Ozurdex.com  OZU110859  10/17  172328

IMPORTANT SAFETY INFORMATION (continued)
Contraindications (continued)
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.

References:
  1. Yau JW, Lee P, Wong TY, Best J, Jenkins A. Retinal vein occlusion: an approach to diagnosis, systemic risk factors and management. Intern Med J. 2008;38(12):904-910.
  2. Laouri M, Chen E, Looman M, Gallagher M. Eye (Lond). The burden of disease of retinal vein occlusion: review of the literature. 2011;25(8):981-988.
  3. Klein R, Klein BE, Moss SE, Meuer SM. The epidemiology of retinal vein occlusion: the Beaver Dam Eye Study. Trans Am Ophthalmol Soc. 2000;98:133-141.
  4. Wu L. Branch retinal vein occlusion. Medscape® Reference website. http://emedicine.medscape.com/article/1223498-overview. Updated August 20, 2012. Accessed July 17, 2013.
  5. Fonrose M. Retinal vein occlusion. Medscape® Reference website. http://emedicine.medscape.com/article/798583-overview. Updated August 20, 2012. Accessed July 17, 2013.
  6. Buddi R, Eliott D. Evaluation and management of retinal vein occlusion. Rev Ophthalmol website. http://www.revophth.com/content/d/retinal_insider/i/1324/c/25432/. Published November 15, 2004. Accessed July 17, 2013.
  7. Hoerauf H. Branch retinal vein occlusion. In: Jousse AM, Gardner TW, Kirchhof B, Ryan SJ, eds. Retinal Vascular Disease. Berlin, Germany: Springer-Verlag; 2007:467-506.
  8. Retinal vessel occlusion. Aetna InteliHealth® website. http://www.intelihealth.com/article/retinal-vessel-occlusion. Updated July 9, 2012. Accessed October 17, 2014.
  9. Jaulim A, Ahmed B, Khanam T, Chatziralli IP. Branch retinal vein occlusion: epidemiology, pathogenesis, risk factors, clinical features, diagnosis, and complications. An update of the literature. Retina. 2013;33(5):901-910.
  10. Garg SJ. Central retinal vein occlusion. The Merck Manuals Online Medical Library website. http://www.merckmanuals.com/professional/eye_disorders/retinal_disorders/central_retinal_vein_occlusion.html. Updated December 2008. Accessed July 17, 2013.
  11. Kooragayala LM. Central retinal vein occlusion. Medscape® Reference website. http://emedicine.medscape.com/article/1223746-overview. Updated September 24, 2012. Accessed July 17, 2013.
  12. Noma H. Clinical Diagnosis in Central Retinal Vein Occlusion. J Med Diagn Meth 2:2 http://dx.doi.org/10.4172/2168-9784.1000119

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OZU88892_v3  05/18  172327

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