No Waiver for Faricimab: CDSCO Panel Asks Roche to Conduct Phase III Trial in India
New Delhi: Roche Products (India) Pvt Ltd has been directed by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial in India for its drug Faricimab (VABYSMO), proposed for the additional indication of macular edema secondary to retinal vein occlusion (RVO).
The matter was re-deliberated in the 7th meeting of the SEC (Ophthalmology) held on 16th July 2025 at CDSCO headquarters in New Delhi. The proposal had earlier been discussed in the SEC meeting dated 19th December 2024, where the firm had requested a waiver for the local Phase III clinical trial.
During the latest meeting, the firm presented justification for the unmet need in India, along with long-term safety data from the global clinical trial for the proposed indication. Roche also reiterated its request for waiver of the local Phase III clinical trial, committing instead to conducting a Phase IV study in India for the proposed indication.
However, the committee noted that appropriate and adequate long-term safety data for the drug product is not available in the Indian population. Furthermore, it was observed that Roche has not yet conducted the Phase IV clinical trial in India for the already approved indications of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), which was an earlier regulatory requirement.
Given these concerns, the committee declined the waiver request. After a detailed deliberation, the SEC decided not to grant approval for the additional indication based solely on global data and restated its earlier recommendation.
"The committee reiterated the earlier SEC recommendation dated 19.12.2024 and recommended the firm to conduct Phase III clinical trial for the proposed indication."
