Dr Peter Cackett, consultant ophthalmologist at the Princess Alexandra Eye Pavilion in Edinburgh, said: "The announcement by the SMC that ranibizumab will be available to people in Scotland with BRVO
is very good news.
The positive CHMP recommendation is based on positive results from the double-masked, randomized, active-controlled phase 3 VIBRANT study in patients impacted by BRVO
EYLEA is approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), which includes both CRVO and BRVO
, and Diabetic Macular Edema (DME).
Patients may describe quadrantanopic or hemi-field visual (field) loss with BRVO
or HRVO respectively.
The EMA submission is based on the positive results from the Phase 3 VIBRANT trial, which was a double-masked, randomized, active-controlled study of patients with macular edema secondary to BRVO
1], 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.
Weeks to months after the onset of BRVO
, collateral vessel formation can be observed characteristically located at the edge of the involved area.
The expanded indication is based on the previously-approved indication for Macular Edema following CRVO and the positive results from the double-masked, randomized, controlled Phase 3 VIBRANT study of 181 patients with Macular Edema following BRVO
The total prevalent cases of ME following BRVO
in the 7MM will increase by 13.
The HRT II can also image other retinal pathologies such as macular holes and puckers, BRVO
, age related macular degeneration and central serous retinopathy.
GlobalData epidemiologists used uniform methodology across the markets to forecast the diagnosed prevalent cases of DME in the diagnosed diabetic retinopathy population and the total prevalent cases of ME following BRVO
and CRVO, to allow for a meaningful comparison of the disease populations across markets.
The EMA submission is based on the positive Phase 3 VIBRANT trial, a double-masked, randomized, active-controlled study of patients with macular edema following BRVO