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Mumbai-based ENTOD Pharmaceuticals met with the Drug Controller General of India (DCGI) earlier this week to address concerns about PresVu eye drops, a press release from the company, published on Thursday, September 26, 2024, said.
The eye drops were initially approved to treat presbyopia in adults, but this approval was issued on September 10, by the Central Drugs Standard Control Organization (CDSCO) after what it said were claims made by the company for the drug, which was previously approved. haven’t got it yet.
In a press release, the CEO of ENTOD, Nikkhil K. Masurkar, said, “We explained the PresVu situation to the DCGI and the sincere and honest intentions behind the media announcement. see the DCGI act swiftly in the public interest and demonstrate good governance.
The company’s clarification says: “PresVu eye drops are not intended to replace reading glasses or non-invasive options for presbyopia. It is a therapeutic option, only available with a prescription from a registered medical practitioner, for patients diagnosed with presbyopia, as assessed by an ophthalmologist.
The release said the press conference was conducted in good faith and that some “explanatory statements were taken out of context in certain news reports and were never our company’s claims.”
Mr. Masurkar, as per the press release, also said that he has assured DCGI with a written promise that ENTOD will fully comply with the restrictive conditions in the permit for PresVu eye drops, and only make approved claims. He also asked the DCGI to reconsider the delay in the approval of PresVu eye drops.
ENTOD’s Vice President of Marketing, Mohammed Kamil Khan, said, “Any future launch of PresVu eye drops will include national academic sessions with ophthalmologists, comprehensive field staff training and chemical counter-awareness regarding the prescription-only status of the eye drops. We also welcome the decision of the top body of ophthalmologists to consider the formation of clinical guidelines for this molecule in the treatment of presbyopia.”
The issue first came into the spotlight after ENTOD Pharmaceuticals issued a press release about eye drops, developed to reduce the dependence on reading glasses for individuals with presbyopia, a common age-related vision condition that usually affects people over 40.
Following the widespread interest, some ophthalmologists began to raise concerns, and the company was asked for an explanation of its ‘unethical and false representation of reality. Ophthalmologists point out that the active ingredient used in the eye drops, pilocarpine, has been used for decades to treat another eye disease, glaucoma, but has now been replaced by newer and better drugs. He also stated that the use of pilocarpine may cause some side effects.
Next, the CDSCO said that the company has made claims for the drug, which have not obtained prior approval from the Central Licensing Authority, thereby violating the provisions under the Clinical Trials and New Drugs Rules, 2019. interest, and because of the possibility of the general public being misled by these claims , the permit has been suspended.
In a statement issued on September 11, ENTOD Pharmaceuticals said it will challenge this suspension in a court of law. At the time, the company said that there were not many unethical or false presentations of facts to the media or the public. He said that media reports about the new product launch went viral and “the public imagination caused an unusual increase for which ENTOD Pharmaceuticals is not responsible.”
(With inputs from ANI)
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Published – 26 September 2024 18:32 IST