ENTOD Pharma appeals to DCGI over suspension, says PresVu eye drops do not replace reading glasses

PresVu eye drops are not intended to replace reading glasses or non-invasive options for presbyopia, ENOTD Pharma has informed Drug Controller General of India

ENTOD Pharmaceuticals, whose eye drop brand PresVu had recently been suspended by the Drug Controller General of India, has submitted a 'written undertaking' assuring full compliance with permissions, and appealed the regulator to reconsider the order, the company informed Moneycontrol on September 26.

The officials of Mumbai-based ENTOD Pharma met Drug Controller General of India (DCGI) officials earlier this week, and informed that PresVu eye drops were not intended to replace reading glasses, or non-invasive options, for presbyopia.

Moneycontrol had reported earlier this month that the company did not obtain approval from the Central Licencing Authority to make such claims for the product.

Nikkhil K Masurkar, ENTOD's CEO, said the company "fully understands the DCGI’s concerns and respects his decision to suspend the permission of PresVu eye drops."

“PresVu eye drops is not intended to replace reading glasses or non-invasive options for presbyopia. It's a therapeutic option, available ONLY by prescription from the registered medical practitioner, for patients diagnosed with presbyopia, as assessed by an eye doctor," Masurkar added.

ENTOD also assured DCGI that any future launch of PresVu drops would include 'nationwide academic sessions' with eye doctors, that'll also underscore the eye drop’s prescription-only status.

The pharma company added that it is currently working on therapeutic treatments for myopia in children, glaucoma, corneal and retinal eye diseases.