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Mumbai-based ENTOD Pharmaceuticals met with the Drug Controller General of India (DCGI) earlier this week to address concerns surrounding the PresVu eye drops, a press release from the company, issued on Thursday, September 26, 2024, said.
The eye drops were initially approved for treating presbyopia in adults, but this approval was suspended on September 10, by the Central Drugs Standard Control Organization (CDSCO) following what it said were claims made by the company for the drug, for which prior approval had not been obtained.
In the press release , ENTOD’s CEO, Nikkhil K. Masurkar, said, “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.”
The company’s clarification 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.”
The release said their press conference had been done in good faith and some “explanatory statements were quoted out of context in certain news reports and never intended to be claims of our company.”
Mr. Masurkar, as per the press release, also said he 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.
Vice President-Marketing of ENTOD, Mohammed Kamil Khan, said, “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.”
The issue first hit the spotlight after ENTOD Pharmaceuticals issued a press release about its eye drops, developed to reduce dependency on reading glasses for individuals affected by presbyopia, a common age-related vision condition that typically impacts those over 40.
Following widespread interest, some ophthalmologists began raising concerns, and the company was asked for an explanation of its ‘unethical and false representation of facts.’ Ophthalmologists pointed out that the active ingredient used in the eye drops, pilocarpine, had been used for decades to treat another eye condition, glaucoma, but had since been replaced with the advent of newer, better drugs. They also pointed out that the use of pilocarpine could cause some side effects.
Subsequently, the CDSCO said the company had made claims for the drug, for which it had not obtained prior approval from the Central Licensing Authority, thereby violating provisions under the New Drugs and Clinical Trial Rules, 2019. It also said that in view of public interest, and due to the likelihood of the general public being misled by these claims, permission had been suspended.
In a statement issued on September 11, ENTOD Pharmaceuticals had said it would challenge this suspension in a court of law. At that point, the company had said that it had not many any unethical or false presentation of facts to the media or the public. It had said media reports on the new product launch went viral and “public imagination led to an unusual escalation for which ENTOD Pharmaceuticals is not responsible.”
(With inputs from ANI)
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Published – September 26, 2024 06:32 pm IST
