Proven in large clinical trials

Study design
Initial-treatment phase
results
3-line gains
Mean change in BCVA
3-line gains
Mean change in BCVA
Extended-treatment phase
results

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials in patients with macular edema following BRVO or CRVO.1-3

  • 427 patients received OZURDEX® 0.7 mg and 426 patients received sham injections1
  • Best-corrected visual acuity (BCVA) was measured using a standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol2

More RVO patients gained 3 lines of vision significantly faster vs sham1,2

20% to 30% of OZURDEX® patients gained 3 lines within 1 to 2 months (vs 7% to 12% with sham)1
  • By day 30, 21.3% of patients treated with OZURDEX® intravitreal implants gained 3 or more lines (vs 7.5% with sham; P < .001)2,3
  • Peak improvement at day 60: 29.3% of patients treated with OZURDEX® gained 3 or more lines (vs 11.3% with sham; P < .001)2,3
  • Significant difference vs sham through day 90 (P < .001)2,3

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials in patients with macular edema following BRVO or CRVO.1-3 Four-hundred twenty-seven patients received OZURDEX® 0.7 mg and 426 patients received sham injections.1 BCVA was measured using a standard ETDRS protocol.3
a NS = not significant.

Regardless of RVO type, more OZURDEX® patients gained 3 lines within 1 to 2 months (than sham-treated patients)2,3

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials in patients with macular edema following BRVO or CRVO.1-3 In BRVO, 291 patients received OZURDEX® 0.7 mg and 279 received sham injections.2 BCVA was measured using a standard ETDRS protocol.3
a NS = not significant.

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials in patients with macular edema following BRVO or CRVO.1-3 In CRVO, 136 patients received OZURDEX® 0.7 mg and 147 received sham injections.2 BCVA was measured using a standard ETDRS protocol.3
a NS = not significant.

RVO patients treated with OZURDEX® gained a mean of 9.8 letters at day 60 (vs 3.1 letters with sham)2,3

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials in patients with macular edema following BRVO or CRVO1-3 Four-hundred twenty-seven patients received OZURDEX® 0.7 mg and 426 patients received sham injections.1 BCVA was measured using a standard ETDRS protocol.3

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials in patients with macular edema following BRVO or CRVO.1-3 In BRVO, 291 patients received OZURDEX® 0.7 mg and 279 patients received sham injections.2 BCVA was measured using a standard ETDRS protocol.3

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials in patients with macular edema following BRVO or CRVO.1-3 In CRVO, 136 patients received OZURDEX® 0.7 mg and 147 patients received sham injections.2 BCVA was measured using a standard ETDRS protocol.3
a NS = not significant.

The design of the extended-treatment phase was identical to the initial-treatment phase.2 Patients from both study groups (ie, active treatment and sham control) who completed
the 180-day initial-treatment phase received OZURDEX® in the study extension if they met
these criteria:
  • BCVA < 84 letters (approximately 20/20) or retinal thickness by OCT > 250 µm in the central 1-mm macular subfield
    AND
  • In the investigator’s opinion, the procedure would not put the patient at significant risk

a
NS = not significant.
b
Excludes randomized patients who did not receive treatment (OZURDEX® or sham) in the initial-treatment phase.
c
Patients in the single-treatment group received OZURDEX® in the initial-treatment phase, but not in the extension (n = 61).2

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials with 6-month extensions in patients with macular edema following BRVO or CRVO. Initial-treatment phase BRVO population: OZURDEX® n = 291; sham n = 279. Extended-treatment phase BRVO population: OZURDEX®/ OZURDEX® n = 288; sham/OZURDEX® n = 276. BCVA was measured using a standard ETDRS protocol.2,3

a
Excludes randomized patients who did not receive treatment (OZURDEX® or sham) in the initial-treatment phase.
b
Patients in the single-treatment group received OZURDEX® in the initial-treatment phase, but not in the extension (n = 14).2

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials with 6-month extensions in patients with macular edema following BRVO or CRVO. BRVO population for disease duration ≤ 90 days: initial-treatment phase: OZURDEX® n = 50; sham n = 44; extended-treatment phase: OZURDEX®/ OZURDEX® n = 50; sham/OZURDEX® n = 43. BCVA was measured using a standard ETDRS protocol.2,3

a
Excludes randomized patients who did not receive treatment (OZURDEX® or sham) in the initial-treatment phase.
b
Patients in the single-treatment group received OZURDEX® in the initial-treatment phase, but not in the extension (n = 47).2

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials with 6-month extensions in patients with macular edema following BRVO or CRVO. BRVO population for disease duration > 90 days: initial-treatment phase: OZURDEX® n = 241; sham n = 235; extended-treatment phase: OZURDEX®/ OZURDEX® n = 238; sham/OZURDEX® n = 233. BCVA was measured using a standard ETDRS protocol.2,3

a
Excludes randomized patients who did not receive treatment (OZURDEX® or sham) in the initial-treatment phase.
b
Patients in the single-treatment group received OZURDEX® in the initial-treatment phase, but not in the extension (n = 61).2

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials with 6-month extensions in patients with macular edema following BRVO or CRVO. Initial-treatment phase BRVO population: OZURDEX® n = 291; sham n = 279. Extended-treatment phase BRVO population: OZURDEX®/ OZURDEX® n = 288; sham/OZURDEX® n = 276. BCVA was measured using a standard ETDRS protocol.2,3

a
NS = not significant.
b
Excludes randomized patients who did not receive treatment (OZURDEX® or sham) in the initial-treatment phase.
c
Patients in the single-treatment group received OZURDEX® in the initial-treatment phase, but not in the extension (n = 19).2

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials with 6-month extensions in patients with macular edema following BRVO or CRVO. Initial-treatment phase CRVO population: OZURDEX® n = 136; sham n = 147. Extended-treatment phase CRVO population: OZURDEX®/ OZURDEX® n = 133; sham/OZURDEX® n = 147. BCVA was measured using a standard ETDRS protocol.2,3

a
NS = not significant.
b
Excludes randomized patients who did not receive treatment (OZURDEX® or sham) in the initial-treatment phase.
c
Patients in the single-treatment group received OZURDEX® in the initial-treatment phase, but not in the extension (n = 19).2

Pooled results of two phase 3, multicenter, randomized, masked, sham-controlled, 6-month trials with 6-month extensions in patients with macular edema following BRVO or CRVO. Initial-treatment phase CRVO population: OZURDEX® n = 136; sham n = 147. Extended-treatment phase CRVO population: OZURDEX®/ OZURDEX® n = 133; sham/OZURDEX® n = 147. 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. OZURDEX® Prescribing Information.
  2. Data on file, Allergan, Inc.
  3. Haller JA, Bandello F, Belfort R Jr, et al; for OZURDEX® GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010;117(6):1134-1146.