Roche Gets CDSCO Panel Nod To study Ophthalmic Drug Faricimab
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New Delhi: Suggesting that the protocol title and phase should be revised for India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to pharmaceutical major Roche for conducting the study of Ophthalmic drug Faricimab.
However, the approval is subject to condition to revise the study title Phase IIIb in place of IIIb/IV. In addition, the expert panel directed that the randomization of the subject should be competitive and more subjects should be randomized.
This came after the firm presented its proposal for Phase IIIb/IV clinical study protocol number MR43808, version 1.0 dated 27-Jan-2022 before the committee.
Faricimab is an IgG1-derived bispecific antibody against VEGF-A and Ang-2 for the treatment of age-related macular degeneration and diabetic macular oedema.
The retina is largely avascular to facilitate effective photoreceptor function; instead, the retina is fed by both retinal and choroidal capillary networks, pathologies of which result in retinal and choroidal vascular diseases such as diabetic macular oedema (DME), age-related macular degeneration (AMD), and retinal vein occlusion (RVO).
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