Study design/patient
demographics
Efficacy in all
randomized patients
Efficacy in
pseudophakic patients
Efficacy in
phakic patients

A phase 3, multicenter, masked, randomized, sham-controlled,
3-year trial1,2

  • Patients randomized to:
    • Sham (needleless applicator) (n = 328)
    • OZURDEX® (dexamethasone intravitreal implant) 0.7 mg (n = 328)
  • Specified treatment interval: no more than approximately every 6 months
  • Evaluations performed at baseline, every 45 days during year 1, and every 3 months during years 2 and 3
  • Escape therapy could be administered at the investigator’s discretion at any point during the study
    • Patients who received escape therapy were withdrawn from the study
    • Efficacy analyses used the last-observation-carried-forward (LOCF) method for these patients

Key efficacy outcome measure1

  • Primary endpoint: Percentage of patients gaining ≥ 15 letters (3 lines) in BCVA from baseline

Key safety measures1

  • Adverse events
  • Intraocular pressure
  • Biomicroscopy
  • Indirect ophthalmoscopy
  • Retroillumination photographs for opacity grading
  • Blood pressure and pulse rate

Results observed in overall patient population:

OZURDEX® sustained clinically significant vision improvements throughout the 3-year MEAD study1

aStandard deviation.

Pooled results of all DME randomized patients with last observation carried forward (LOCF) from 2 multicenter, masked, randomized, sham-controlled studies. The primary endpoint was the proportion of patients with 15 or more letters improvement in BCVA from baseline at month 39 or final visit for subjects who exited the study at or prior to month 36. The month 39 extension was included to accommodate the evaluation of safety and efficacy outcomes for subjects who received re-treatment at month 36. Only 14% of the study patients completed the month 39 visit (16.8% from OZURDEX® and 12.2% from sham).

Efficacy observed in pseudophakic patients:

OZURDEX® demonstrated BCVA improvement from baseline

Pooled results from 2 multicenter, masked, randomized, sham-controlled, 3-year studies in patients with DME. Subgroup for pooled data with LOCF. BCVA was measured using a standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.2,3

Clinical outcomes observed in phakic patients:

Pooled results of all phakic DME randomized patients with LOCF from 2 multicenter, masked, randomized, sham-controlled studies. The primary endpoint was the proportion of patients with 15 or more letters improvement in BCVA from baseline at month 39 or final visit for subjects who exited the study at or prior to month 36. The month 39 extension was included to accommodate the evaluation of safety and efficacy outcomes for subjects who received re-treatment at month 36. Only 14% of the study patients completed the month 39 visit (16.8% from OZURDEX® and 12.2% from sham).2

  • 68% of phakic OZURDEX® patients (n = 243) experienced a cataract versus 21% of sham patients (n = 230)2
  • The occurrence of cataracts impacted visual acuity during the study2

Pooled results from 2 multicenter, masked, randomized, sham-controlled, 3-year trials in studies with DME. Subgroup for pooled data with LOCF. BCVA was measured using a standard ETDRS protocol.2,3

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.

References:
  1. Data on file, Allergan, Inc.
  2. OZURDEX® Prescribing Information.
  3. Boyer DS, Yoon YH, Belfort R Jr, et al; OZURDEX® MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014;121(10):1904-1914.