Mumbai-based Entod Pharmaceuticals met with the Drug Controller General of India (DCGI) earlier this week to address the concerns raised regarding its yet-to-be-launched PresVu eye drops.
The eye drops, Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent, were approved for treating presbyopia in adults earlier in August. This approval was subsequently suspended by the DCGI earlier this month for reasons including concern that the by-prescription product might be used like an over-the-counter drug.
Entod CEO Nikkhil K Masurkar said they had met the drug regulator and explained their situation. He clarified, “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 a registered medical practitioner, for patients diagnosed with presbyopia, as assessed by an eye doctor.”
Masurkar gave a written undertaking to the DCGI on complying with conditions outlined in the approval for PresVu eye drops and to make claims that have been approved. He also appealed to the DCGI to reconsider the suspension of the approval of PresVu eye drops.
On the public announcement made by the company ahead of its launch, he said, it was “done in good faith.” In the process of explaining the treatment of presbyopia, “we stated the data from the Indian phase 3 clinical trial with respect to the 15-minute onset of action and about the possibility of replacing reading glasses. It appears that some of these explanatory statements were quoted out of context ....and never intended to be claims of our company,” he said, adding that they understood how the communication could “potentially be misleading to the public.”
Entod’s Vice President of Marketing, Mohammed Kamil Khan, added that any future launch of PresVu eye drops would include nationwide academic sessions with eye doctors, thorough field staff training and chemist counter awareness about the eye drop’s prescription-only status. “We also welcome the decision of the apex body of ophthalmologists to consider the formation of clinical guidelines for this molecule in the treatment of presbyopia,” he said.
The company has over 150 ophthalmic formulations in the domestic market for various eye ailments and supplies 67 countries.