OZURDEX® Mechanism of Action | OZURDEX® for HCPs

For diabetic macular edema (DME)
For macular edema following branch retinal vein occlusion (BRVO)
or central retinal vein occlusion (CRVO)
For noninfectious posterior segment uveitis

Mechanism of Action
NOVADUR^® Drug Delivery System

OZURDEX^® TARGETS MULTIPLE

INFLAMMATORY CYTOKINES

OZURDEX^® is a sustained-release, biodegradable steroid implant containing dexamethasone, a corticosteroid⁴
Dexamethasone has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines, resulting in decreased⁴:

Edema
Fibrin deposition

Capillary leakage
Migration of inflammatory cells

SEE HOW OZURDEX^® WORKS TO TREAT

DIABETIC MACULAR EDEMA (DME)

Transcript

SEE 3-YEAR CLINICAL EFFICACY

GO

SEE HOW OZURDEX^® WORKS TO TREAT

MACULAR EDEMA FOLLOWING RVO

(BRVO OR CRVO)

Transcript

HOW OZURDEX^® WORKS IN

NONINFECTIOUS POSTERIOR

SEGMENT UVEITIS

Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells⁴
In noninfectious posterior segment uveitis, evidence suggests that inhibition of the cytokine NF-kB plays a key role in suppression of inflammation⁷

NOVADUR^® TECHNOLOGY:

A PROPRIETARY DRUG DELIVERY SYSTEM

A sustained-release, biodegradable steroid implant⁴

Solid polymer matrix contains 0.7 mg of dexamethasone, a corticosteroid⁴
Biodegrades to lactic acid and glycolic acid⁴
Administered by injection as an in-office procedure⁴

Tiny

implant

Before

implantation

3 weeks

after implantation

Scanning electron microscopy (SEM) magnification of implant surface in an animal model. Clinical significance unknown.³

A PATENTED

INTRAVITREAL APPLICATOR

Sterile, single-use applicators are supplied preloaded with an implant⁴
Includes second-generation needle
Implants are administered using a shelved injection technique⁴

SEE HOW THE OZURDEX^®

APPLICATOR WORKS

Transcript

Click here to access injection technique educational resources.

HELP PATIENTS LEARN MORE ABOUT OZURDEX^® FOR THEIR CONDITION

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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^® 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.

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.

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 are not recommended to be used 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.

Please see accompanying full Prescribing Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf

US-OZU-230032

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.

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.

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^® 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.

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.

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 are not recommended to be used 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.

Please see accompanying full Prescribing Information or visit https://www.rxabbvie.com/pdf/ozurdex_pi.pdf

US-OZU-230032