Allergan announced today that the European Medicines Agency (EMA) has extended the Marketing Authorisation for OZURDEX® (dexamethasone 0.7mg intravitreal implant in applicator) in the 27 member states of the European Union to include the treatment of inflammation of the posterior segment of the eye presenting as non-infectious uveitis.1 OZURDEX® is already available in many countries in Europe as the first treatment licensed for macular oedema in patients with retinal vein occlusion (RVO).

Posterior segment uveitis is defined as uveitis in the middle and back of the eye. Uveitis is a condition which results in inflammation of the middle layer of the eye (the uvea) and can cause significant vision impairment that may even progress to blindness.2 The incidence of uveitis is highest in the working age group of 20 - 50 years old.3

OZURDEX® was developed specifically for the treatment of retinal disease and was first authorised in Europe for the treatment of macular oedema in patients with retinal vein occlusion (RVO). OZURDEX® consists of a biodegradable polymer implant containing dexamethasone - a highly potent corticosteroid - in a specially designed single use applicator, administered by intravitreal injection into the back of the eye, giving sustained release of active medication for up to 6 months.1,4-5 Dexamethasone is slowly released from the biodegradable implant into the back of the eye and suppresses inflammation resulting in an improvement of visual acuity.6

"We are pleased that the European Medicines Agency has granted marketing authorisation for OZURDEX® in uveitis," said Douglas Ingram, President, Allergan, Europe, Africa and the Middle East. "This newest authorisation is consistent with Allergan's continuing commitment to the development of innovative new treatments that serve retinal physicians and help preserve vision for patients suffering from retinal diseases."

The safety and efficacy of OZURDEX® in the treatment of non-infectious uveitis in the posterior segment of the eye was assessed in the HURON (cHronic Uveitis evaluation of the intRavitreal dexamethasONe implant) phase III study.6 HURON consisted of a 26-week, prospective, multicentre, masked, randomised, parallel-group, clinical trial which compared OZURDEX® versus a sham procedure, in 229 patients with non-infectious, posterior segment uveitis with a vitreous haze score of ≥ + 1.5. The main outcome measurement in the HURON data was the proportion of eyes with a vitreous haze score of 0 at week 8, indicating no inflammation.

The results from the HURON study showed that:

- Approximately 4 times as many patients treated with OZURDEX® (0.7 mg) had complete resolution of vitreous haze due to reduction in inflammation (defined as achieving a vitreous haze score of 0) compared with sham at the 8-week primary endpoint (47% versus 12% respectively)6

- One injection of OZURDEX® (0.7 mg) provided statistically significant superiority over sham in the mean change of best corrected visual acuity (BCVA) at each follow up visit from week 3 to week 266

- Patients treated with OZURDEX® (0.7 mg) achieved a statistically significant and clinically relevant improvement in visual functioning and vision specific health-related quality of life compared to sham as measured by NEI VFQ-257

- OZURDEX® treatment (0.7 mg) for posterior segment non-infectious uveitis was generally well-tolerated, with manageable adverse effects6

"Until the approval of Ozurdex, ophthalmologists have been limited in the available local treatment options for patients with posterior segment uveitis." said Professor Sue Lightman, Professor of Clinical Ophthalmology at the UCL Institute of Ophthalmology and Consultant Ophthalmologist at Moorfields Eye Hospital, one of the lead investigators in the HURON study. "The clinical trials in patients with uveitis suggest that a single injection of Ozurdex can be effective at improving vision by controlling intraocular inflammation and is generally well tolerated with a low rate of cataract and a low rise in intraocular pressure. In addition, as Ozurdex also lasts up to six months, it should prove a very useful option for the management of patients who do not wish to have high dose oral steroids." Allergan anticipates launching the new indication of inflammation presenting as non-infectious uveitis in the posterior segment of the eye to European physicians starting the third quarter of 2011.

Notes

About Uveitis

Uveitis is characterized by inflammation of the eye's uvea, which is the middle vascular layer consisting of the iris (anterior), ciliary body (intermediate) and choroid (posterior). Uveitis of the anterior (front) of the uvea is more common and typically does not lead to vision impairment;2 while posterior uveitis (back of the eye) is associated with more severe outcomes that can include blindness, cataracts, secondary glaucoma and macular abnormalities.2 Posterior and intermediate (middle of the eye) uveitis causes floaters (black dots or wispy lines), blurred vision8 and arises when damage occurs to the uvea either from an underlying known disease (e.g. inflammatory bowel disease) or with no know systemic association.8 Uvea damage leads to an inflammatory process9 which causes exudation of fluids from the macula region of the retina, resulting in vitreous haze and macular oedema.10 Uveitis is the fifth leading cause of visual loss in Europe;3 however, non-infectious posterior segment uveitis makes up a small proportion of uveitis cases. The large majority of cases occur in people between 20 to 50 years old,3 with around half occurring in people in their 30s and 40s.2

More severe cases of non-infectious intermediate and non-infectious posterior uveitis are typically treated with local and systemic steroids along with immunosuppressants in certain cases.11 Steroids that are administered systemically for a prolonged period of time may have potential serious systemic side effects that can limit the use of the drugs.12 Tablets and injections are needed to deliver the drug effectively to the middle and back of the eye.

References

1. Ozurdex® Summary of Product Characteristics

2. Suttorp-Schulten MSA et al. The possible impact of uveitis in blindness: a literature survey. Br J Ophthalmol 1996;80:844-8.

3. Durrani OM et al. Degree, duration and causes of visual loss in uveitis. Br J Ophthalmol 2004;88:1159-62.

4. Kuppermann BD et al. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol 2007;125:309-17.

5. Haller JA et al. Evaluation of the safety and performance of an applicator for a novel intravitreal dexamethasone drug delivery system for the treatment of macular edema. Retina 2009;29:46-51.

6. Lowder L et al. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol, published online 10 January 2011.

7. Allergan data on file

8. Nussenblatt RB et al. Uveitis: Fundamentals and Clinical Practice. 3rd ed. St. Louis: Mosby. 2004.

9. Forrester JV. Uveitis: pathogenesis. Lancet 1991;338:1498-50.

10. Yu EN. Cystoid Macular Edema. Available here. 2010.

11. Sudharshans S et al. Current approach in the diagnosis and management of posterior uveitis. Indian J Ophthalmol 2010;58(1):29-43.

12. Zakka FR et al. Current trends in the management of ocular symptoms in Adamantiades-Behçet's disease. Clinical Ophthalmology 2009;3:567-79.

Source:
Allergan