Suspended eye drops not intended to replace glasses, says Entod CEO
Mumbai-based Entod Pharmaceuticals clarified that its eye drop PresVu is not intended to replace reading glasses for presbyopia. This follows the Indian drug regulator's suspension of its manufacture and sale due to unapproved claims. The company'...
The regulatory action to suspend the manufacture and sale of the eye drop came after the licensing authorities said the company did not get its clearance on its claim that the medicine reduces dependency on reading glasses for those affected by presbyopia.
The company's CEO, Nikkhil K Masurkar, Thursday said the eye drop "is a therapeutic option."
Masrukar met the drug controller earlier this week and said that it was justified on the part of DCGI to suspend the approval. He had met the DCGI to address concerns surrounding Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v (PresVu eye drops), which were approved for treating presbyopia in adults on August 6. However, the drug controller suspended its permission on September 10 following potentially misleading claims.
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