Ozurdex (dexamethasone 700mcg) sustained-release ocular implant receives Pharmac approval for diabetic macular oedema

From 1 November, a sustained-release ocular implant OZURDEX® (dexamethasone 700mcg) will be available and funded for eligible people with diabetic macular oedema (DMO).^1,2 It will be listed in both Section B (Community) and Part II of Section H (Hospital) of the Pharmaceutical Schedule, and will be made available to patients with DMO who have had cataract surgery and for whom the currently available treatments are either ineffective or inappropriate (further criteria apply).^1,2

DMO occurs as a result of inflammatory processes in the eye, involving expression of inflammatory mediators including vascular endothelial growth factor (VEGF), intercellular adhesion molecule-1, interleukin-6 and monocyte chemotactic protein-1. This inflammation causes breakdown of the blood-retinal barrier, which in turn leads to capillary leakage and accumulation of fluid in the macular area of the eye, resulting in retinal thickening and blurred vision.^3-5

OZURDEX® is a biodegradable intravitreal rod-shaped implant containing 700mcg dexamethasone.² OZURDEX® targets multiple inflammatory mediators involved in the generation and regulation of the inflammatory response in DMO, reducing breakdown of the blood-retinal barrier and targeting local inflammation.^2,3,6,7 It is injected into the eye (vitreous cavity) by an Ophthalmologist, using a specifically designed single-use applicator.² The implant is designed to provide sustained delivery, slowly releasing a potent corticosteroid (dexamethasone) directly into the vitreous, resulting in less frequent injections compared to anti-VEGFs.^2,3,18,19 Diabetic retinopathy (DR) is the leading cause of preventable blindness among adults aged 20–74 years.^4,8,9 . DMO, which involves retina thickening, is a major complication of DR³. It is estimated 15,000 New Zealanders suffer from DMO^10-12, and approximately 30% of these patients are pseudophakic, one of the criteria for the reimbursement of OZURDEX® injections.^1,3,13

In New Zealand, approximately 6% of the population over the age of 15 are currently living with diabetes; an estimated 217,000 people.¹⁴ University of Auckland Ophthalmologist, Dr Philip Polkinghorne commented: “Diabetes is an ever-increasing problem in New Zealand, and is particularly prevalent in the Maori and Pacific Islander populations. Many of these patients already inject insulin, so the additional burden of frequent injections for DMO can severely affect independence and quality of life”.¹⁵

“Patients with DMO often have at least one other chronic condition, which requires effective management by both clinicians and patients, so anything we can do to reduce the frequency of healthcare appointments will be really important for easing the burden of diabetes management”,¹⁶ added Dr Polkinghorne.

Currently available treatments for DMO include anti-VEGFs, but some patients are non-responsive to this treatment. A recent study showed that more than 35% of patients with DMO fail to achieve ≥10-letter improvement in best-corrected visual acuity (BCVA) after 2 years of first-line anti-VEGFs.¹⁷

“For some patients anti-VEGF treatments are less effective than we would like so it is important that New Zealanders with diabetes and DMO have access to alternative treatments in order to avoid preventable sight loss”,¹⁷ Dr Polkinghorne concluded.

In clinical trials, OZURDEX® delivered a rapid and significant vision improvement of 15 or more letters compared with sham treatment in the whole population of DMO patients.³ OZURDEX® provided sustained, long-term improvements in vision in DMO patients with a mean of four injections over three years, compared with sham treatment (22.2% patients had a ≥15-letter improvement from baseline with OZURDEX® 700mcg versus 12.0% with sham; P≤0.018).³ OZURDEX® also promotes rapid CRT reduction, with significant and sustained visual gains.³

The efficacy and tolerability profile of OZURDEX® for the management of patients with DMO is supported by two 3-year, multicentre, double-masked, randomised, sham-controlled phase III studies involving over 1,000 patients as part of the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) clinical trials program. Only a small percentage of patients in this trial experienced ocular adverse events with OZURDEX®, including 1.4% retinal tear and 0.6% for each of retinal detachment, endophthalmitis and hypotony of the eye.³ Less than 1 in 3 patients experienced an IOP increase from baseline of ≥10 mmHg.³ Elevations in IOP did not have a cumulative effect and were manageable with topical IOP-lowering treatment.³

OZURDEX® intravitreal implant is funded medicine on the New Zealand Pharmaceutical Schedule – restrictions apply.

BEFORE PRESCRIBING, PLEASE REVIEW APPROVED DATA SHEET AVAILABLE ON REQUEST FROM ALLERGAN BY PHONING 0800 659 912 OR FROM THE MEDSAFE WEBSITE.

New Zealand Minimum Data Sheet

OZURDEX® 700 µg dexamethasone intravitreal implant is a prescription medicine which contains dexamethasone 700 µg.

Indications: treatment of macular oedema due to retinal vein occlusion (RVO); treatment of adult patients with visual impairment due to diabetic macular oedema (DMO) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy; treatment of non-infectious uveitis affecting the posterior segment of the eye.

Dosage: 700 µg per eye (entire contents of a single-use OZURDEX® device).

Contraindications: Hypersensitivity to ingredients; active/suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases; advanced glaucoma; aphakic eye with rupture of the posterior lens capsule; eyes with an anterior chamber intraocular lens (ACIOL), iris or transscleral fixated IOLs, and rupture of the posterior lens capsule.

Precautions: Proper aseptic injection techniques must always be used. Patients should be monitored for infection or increased IOP. Patients who had a tear in the posterior lens capsule or who had an iris opening to the vitreous cavity are at risk of implant migration, which might lead to corneal oedema. Corticosteroids have been associated with posterior subcapsular cataracts, increased IOP, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses; history of or active ocular herpes simplex; OZURDEX® is not recommended during pregnancy unless the potential benefits justifies the potential risks to the foetus; not recommended during breast-feeding unless necessary; use in children has not been studied; temporary visual blurring may occur after injection of OZURDEX®, therefore, patients should not drive or use machines until this has resolved; administration to both eyes on the same day is not recommended.

Adverse Effects (≥1%): cataract, cataract subcapsular, cataract nuclear, lenticular opacities, IOP increased, ocular hypertension, conjunctival haemorrhage*, vitreous haemorrhage*, eye pain*, vitreous detachment*, vitreous floaters*, conjunctival oedema*, vitreous opacities*, anterior chamber inflammation*, visual acuity reduced, endophthalmitis, hypotony of eye, retinal detachment, complication of device insertion, device dislocation, conjunctival hyperaemia*, visual disturbance, photopsia*, headache, myodesopsia, blepharitis, abnormal sensation in the eye*, eyelid pruritus, scleral hyperaemia*, visual impairment, migraine, anterior chamber cell*.

About Allergan

Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercialises innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential — to see more clearly, move more freely, express themselves more fully. The company employs approximately 10,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery to development research organisation, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.