Thu Sep 26 13:06:57 UTC 2024: ## Entod Pharmaceuticals Appeals to DCGI to Reinstated Approval of Presbyopia Eye Drops
Mumbai-based Entod Pharmaceuticals has appealed to the Drug Controller General of India (DCGI) to reconsider the suspension of its PresVu eye drops, a treatment for presbyopia. The DCGI had suspended the approval earlier this month, concerned that the prescription-only drug might be marketed like an over-the-counter product.
Entod CEO Nikkhil K Masurkar clarified that PresVu is not intended to replace reading glasses and is only available with a prescription from a qualified medical practitioner. He said the company had met with the DCGI to explain their situation and had given a written undertaking to comply with all approval conditions.
Masurkar acknowledged that some statements made in the company’s public announcement ahead of the launch may have been misinterpreted, leading to the public perception that PresVu could be used as an over-the-counter product. He said the company intended to provide clear and accurate information about the treatment, but acknowledged that their communication might have been misleading.
In response, Entod has pledged to conduct nationwide academic sessions for eye doctors, provide thorough training for their field staff, and ensure chemists are aware of the prescription-only status of PresVu. They also welcome the decision by the apex body of ophthalmologists to develop clinical guidelines for the use of this molecule in treating presbyopia.
Entod Pharmaceuticals is a leading ophthalmic formulation company with over 150 products in the domestic market and exports to 67 countries.
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