Faricimab, an eye medicine from Roche, should be approved with a local phase III trial waiver, according to the SEC.

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Faricimab intravitreal injection, manufactured by Swiss multinational pharmaceutical company Roche, has been approved for import and marketing in India, with the local phase III clinical trial being waived subject to conditions, according to the expert committee’s recommendation. To treat Neto vascular (wet) age-related macular degeneration (nAMD) and diabetic macular edoema (DME), Roche Products (I) Pvt Ltd has offered the drug faricimab 6 mg/0.05 ml solution for intravitreal injection. The medicine was introduced in the US under the brand name Vabysmo.

The Subject Expert Committee (SEC) for ophthalmology, considered the proposal and noted that the applied drug is approved in 57 countries including USA, Canada, European Union, Australia, Japan, United Kingdom and others and the product has a novel mechanism of action in comparison to existing products. Further, the firm stated that in the phase III clinical trials performed globally there were Asian population also. “After detailed deliberation, the committee recommended grant of permission for import and marketing of the drug with local phase III clinical trial waiver subject to condition that firm should conduct phase IV clinical trial,” said the SEC in its recent meeting. Accordingly, phase IV clinical trial protocol should be submitted within three months of marketing approval, it added.

Experts have compared the medication to Regeneron’s best-selling medication Eylea since it received FDA approval in early 2022. According to Roche, the two main causes of vision loss worldwide are neovascular AMD and DME, which were mentioned during the announcement of the FDA’s clearance of the drug on January 31, 2022.

Vabysmo neutralises angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A to target and inhibit two disease pathways connected to a number of vision-threatening retinal diseases (VEGF-A). Based on an assessment of the patient’s anatomy and visual outcomes, it is the first and only FDA-approved injectable eye medication for nAMD and DME that improves and maintains vision with treatments spaced one to four months apart in the first year after four first monthly doses. According to the firm, eye injections every one to two months are considered standard of care for nAMD and DME.

The area of the eye that gives the clear, centre vision required for tasks like reading is impacted by AMD. Neovascular AMD (nAMD), sometimes known as “wet” AMD, is an advanced type of the disease that, if unchecked, can lead to rapid and severe vision loss. According to the business, DME, which affects over 21 million individuals worldwide, is a retinal disorder that threatens eyesight and, if left untreated, can lead to blindness and a lower quality of life. DME happens when retinal blood vessels that are damaged leak and bulge the macula, the part of the retina that provides the clear vision required for reading and driving. According to the report, more people are anticipated to have DME as the prevalence of diabetes rises.


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