Roche gets CDSCO Panel nod to import, market ophthalmic drug Faricimab solution

However, this approval is subjected to a condition that the firm should submit the Phase IV clinical trial protocol within 3 months of marketing approval.

This came after the firm presented the proposal to import and market Faricimab 6mg/0.05mL solution for intravitreal injection indicated for the treatment of Neovascular (wet) age-related macular degeneration (nAMD) and Diabetic Macular edema (DME) with a request for waiver of Phase III clinical trial in the country.

Wet macular degeneration is a long-lasting eye disorder that causes blurred vision or a blind spot in the central vision. It's usually caused by blood vessels that leak fluid or blood into the macula. The macula is the part of the retina that gives the eye clear vision in the direct line of sight. Wet macular degeneration is one of two types of age-related macular degeneration.

Diabetic macular edema (DME) is the accumulation of excess fluid in the extracellular space within the retina in the macular area, typically in the inner nuclear, outer plexiform, Henle’s fiber layer, and subretinal space.

Faricimab is an IgG1-derived bispecific antibody against VEGF-A and Ang-2 for the treatment of age-related macular degeneration and diabetic macular edema. Faricimab suppresses endothelial proliferation, neovascularization, and vascular permeability, which are associated with the increased retinal thickness observed in nAMD and DME.

At the recent SEC meeting for Ophthalmology held on 22nd February 2023, the expert panel reviewed the proposal presented by the drug major Roche for the importing and marketing of the monoclonal antibody Faricimab.

The committee noted that the applied drug is approved in 57 countries including the USA, Canada, EU, Australia, Japan, and the UK. Furthermore, the committee noted that the product has a novel mechanism of action in comparison to existing products.

In addition, the firm stated that in Phase III clinical trials performed globally there were an Asian populations also.

After detailed deliberation, the committee recommended the grant of permission for the import and marketing of the drug with a local Phase III clinical trial waiver subject to the condition that the firm should conduct a Phase IV clinical trial.

Accordingly, the expert panel directed the firm to submit the Phase IV clinical trial protocol within 3 months of marketing approval.

Also Read:Roche Gets CDSCO Panel Nod To study Ophthalmic Drug Faricimab