First Head-to-head Study in Branch Retinal Vein Occlusion(BRVO) Announced in Europe and IsraelBy Allergan, PRNE
Tuesday, June 7, 2011
MARLOW, England, June 8, 2011 -
- First Patient to be Enrolled in Comparison of Intravitreal
Dexamethasone Implant and Ranibizumab for Macular Oedema in BRVO (COMO) Study
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., 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
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., 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.
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."
 Klein R, Klein BEK, Moss SE, Meuer SM. Tr Am Ophth Soc
 United Nations population estimates [UN World Population 2010].
Available at esa.un.org/unpp/ (Accessed 3 August 2009)
 Kuppermann BD, Blumenkranz MS, Haller JA, et al. Arch Ophthalmol
 Haller JA, Dugel P, Weinberg DV, et al. Retina 2009;29:46-51.
 Haller JS, Haller JA, Bandello F, et al. Ophthalmology
Janet Kettels: +44(0)7738-5064-76 or kettels_janet at allergan.com. Sarra Martin: +44 (0)7850-720-466 or sarramartin at synergymedical.co.uk
Tags: Allergan, England, Israel, June 8, Marlow, United Kingdom