First Head-to-head Study in Branch Retinal Vein Occlusion(BRVO) Announced in Europe and Israel

MARLOW, England, June 8, 2011 /PRNewswire/ --

- First Patient to be Enrolled in Comparison of Intravitreal Dexamethasone Implant and Ranibizumab for Macular Oedema in BRVO (COMO) Study This Summer

Allergan Ltd. announced today the first head-to-head study in branch retinal vein occlusion (BRVO), a sight threatening eye condition that impacts approximately 300,000 people in the EU each year.[1],[2] Called the COmparison of intravitreal dexamethasone implant and ranibizumab for Macular Oedema in BRVO (COMO), the objective of the study is to assess the relative effectiveness of two distinct therapies for BRVO, OZURDEX(R) (dexamethasone 0.7 mg intravitreal implant) versus ranibizumab. Recruitment for the COMO 12-month study starts this summer from at least 36 sites across Europe and Israel.

Approximately 400 patients suffering from macular oedema following BRVO of <90 days duration will be enrolled into the COMO study and randomised to receive treatment with either OZURDEX(R) or ranibizumab. Patients randomised to the OZURDEX(R) group will receive an intravitreal injection on day 1 and another in month 5, with a further injection at month 10 or 11, if required. Those patients in the ranibizumab group will receive 6 intravitreal injections on a monthly basis from day 1 through to month 6, and then monthly as needed from month 6 through to month 11. The primary endpoint will be the mean change from baseline in best-corrected visual acuity (BVCA) at month 12.

OZURDEX(R) is available in many countries in Europe and is the first licensed treatment for adult patients with macular oedema following either BRVO or central RVO (CRVO). OZURDEX(R) is an innovative, first-of-its-kind biodegradable intravitreal implant of dexamethasone, a highly potent corticosteroid, administered via a specially designed, single use applicator.[3],[4] Dexamethasone is slowly released from the implant over a period of several months into the vitreous and acts locally to control oedema and reduce inflammation around the occlusion. GENEVA, the very first phase III randomised clinical trial in RVO, demonstrated that OZURDEX(R) improved patients' visual acuity for up to six months with a single injection.[5]

Ranibizumab injections are typically given monthly to reduce macular oedema. The BRAVO trial, which commenced two years after the GENEVA trial, showed ranibizumab was effective in improving visual acuity in patients with a short duration of macular oedema following BRVO.

"We are pleased with the commencement of COMO, the first head-to-head study exploring the relative benefits of two important new approaches to the treatment of BRVO," said Mr. Douglas Ingram, President, Allergan, Europe, Africa and the Middle East. "At Allergan, we are proud of our commitment to scientific discovery, using our knowledge of complex disease states such as retinal disease. The COMO study initiation is an important milestone for Allergan's Retina franchise and demonstrates our continuing commitment to developing innovative new treatments that can help preserve vision for patients suffering from retinal diseases."

References

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[1] Klein R, Klein BEK, Moss SE, Meuer SM. Tr Am Ophth Soc 2000;98:133-43.

[2] United Nations population estimates [UN World Population 2010]. Available at http://esa.un.org/unpp/ (Accessed 3 August 2009)

[3] Kuppermann BD, Blumenkranz MS, Haller JA, et al. Arch Ophthalmol 2007;125:309-17.

[4] Haller JA, Dugel P, Weinberg DV, et al. Retina 2009;29:46-51.

[5] Haller JS, Haller JA, Bandello F, et al. Ophthalmology 2010;117:1124-46