Roche gets CDSCO panel Nod To study safety, and efficacy of Faricimab Intravitreal injection
New Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase IV study in patients with Neovascular age-related macular degeneration or diabetic macular edema to evaluate the safety and effectiveness of the Faricimab Intravitreal injection in India.
In regard to the above, the committee suggested that the number of subjects should be a minimum of 100. In addition, the panel stated that Subjects should be discontinued from the study when there is any worsening condition/adverse event in the treatment eye. "Subsequently, the patients should be provided with a standard of care", the expert panel added.
This came after the drug major Roche presented their proposal to conduct a Phase IV clinical trial protocol titled “A Phase IV, Multicenter, Open-label, Single-Arm study in patients with Neovascular age-related macular degeneration or diabetic macular edema to evaluate the safety and effectiveness of the Faricimab Intravitreal injection in India (Vitreal study)” vide protocol No. ML45007 version 1.0 dated 10.07.2023.
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 is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
At the recent SEC meeting for ophthalmology held on 18th October 2023, the expert panel reviewed the proposal to conduct Phase IV clinical trials protocol titled “A Phase IV, Multicenter, Open-label, Single-Arm study in patients with Neovascular age-related macular degeneration or diabetic macular edema to evaluate the safety and effectiveness of the Faricimab Intravitreal injection in India (Vitreal study)” presented by drug major Roche.
After detailed deliberation, the committee recommended approval of the study protocol with the following changes in the protocol;
1. The number of subjects should be a minimum of 100.2. Subjects should be discontinued from the study when there is any worsening condition/adverse event in the treatment eye. Subsequently, the patients should be provided with a standard of care.3. Treatment of other eye as per standard of care should be included in the protocol.
Accordingly, the expert panel stated that the firm should submit a revised protocol to CDSCO.
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