Mumbai-based ENTOD Pharmaceuticals on Thursday announced that the company leadership has met with the Drug Controller General of India (DCGI) earlier this week to address concerns surrounding PresVu eye drops. The eye drops were approved for treating presbyopia in adults on 6 August 2024. However, the drug controller suspended its permission on 10 September 2024 after health experts raised concern over its safety following the company’s announcement.
“We explained the PresVu situation to the DCGI and our sincere and honest intentions behind the media announcement. ENTOD fully understands the DCGI’s concerns and respects his decision to suspend the permission of PresVu eye drops following hyped claims in news reports. It is also praiseworthy to see the DCGI take swift action in the public interest and demonstrate such good governance,” ENTOD’s CEO, Nikkhil K Masurkar, said in a statement.
Masurkar issued a clarification statement that said “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.”
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In a press conference, conducted earlier this month, the company claimed that the DCGI has given final approval to the eye drops.
During the press conference, the company’s leadership team claimed that PresVu is the first eye drop in India specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia.
Following media reports on the announcement, experts and health officials claimed that the company is presenting wrong facts. Days later, the DCGI suspended the permission granted to Entod Pharmaceuticals to make and sell the product.
“Our press conference was done in good faith. In the process of explaining this treatment of presbyopia, we stated the data from the Indian phase 3 clinical trial with respect to the 15-minute onset of action & about the possibility of replacing reading glasses. It appears that some of these explanatory statements were quoted out of context in certain news reports and never intended to be claims of our company. Subsequent to the discussions with the DCGI, we understand how the implications of these would be perceived by lay people and how it could potentially be misleading to the public,” Masurkar said.
Masurkar further said that this is why it has became necessary for us to issue a clarification for PresVu eye drops to the media and the public. “As a regulatory compliant and responsible pharmaceutical company, and as one of the leaders in eye care in India with nearly half a century of ophthalmic expertise, ENTOD has built substantial goodwill and trust with doctors, patients and trade partners over the years,” he said.
Masurkar has assured the DCGI with a written undertaking that ENTOD will fully comply with conditions outlined in the permission for PresVu eye drops, and make only approved claims. He also appealed to the DCGI to reconsider the suspension on the approval of PresVu eye drops.
“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,” Vice President-Marketing, Mohammed Kamil Khan, said in a stated.
The company has over 150 ophthalmic formulations in the domestic market for various eye ailments and supplies to 67 countries globally. Its R&D is currently working on cutting-edge therapeutic treatments for myopia in children, glaucoma, corneal diseases and retinal eye diseases, the company added.
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