In its press releases and social media posts, the company claimed that the eye drops would help people eliminate the need for reading glasses. The drug authority highlighted that, given the various media reports, there is a likelihood that the general public could be misled by the company's unapproved claims.
Published Sep 11, 2024 | 6:20 PM ⚊ Updated Sep 11, 2024 | 7:03 PM
Entod Pharmaceuticals developed PresVu Eye Drops for the treatment of presbyopia
In an order issued on Tuesday, 10 September, the Central Drugs Standard Control Organisation (CDSCO) suspended the production and marketing approval of PresVu eye drops produced by Entod Pharmaceuticals Ltd until further notice.
Mumbai-based Entod Pharmaceuticals developed PresVu Eye Drops for the treatment of presbyopia, a condition that affects an estimated 1.09 billion to 1.80 billion people globally.
Presbyopia is a natural part of ageing, causing difficulty in focusing on close objects. It typically begins in the mid-40s and worsens until around the late 60s.
The company had previously claimed that the use of PresVu Eye Drops could eliminate the need for reading glasses.
So, why did the CDSCO revoke approval for PresVu if it had the potential to treat presbyopia?
On 20 August, the CDSCO granted permission to Entod Pharmaceuticals for the manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v, intended for the treatment of presbyopia in adults.
On 3 September, the company held a press conference where several claims were made regarding the product.
However, in its press releases and social media posts, the company claimed that the eye drops would help people eliminate the need for reading glasses.
“PresVu has been applied for a patent for its formulation and process. The proprietary formula not only eliminates the need for reading glasses but also provides the added benefit of lubricating the eyes. These eye drops utilise advanced dynamic buffer technology to quickly adapt to tear pH, ensuring consistent efficacy and safety for long-term use, keeping in mind that such drops will be used for years,” stated a press release issued by the pharmaceutical company.
The company claimed that PresVu could offer an advanced alternative that enhances near vision within 15 minutes of use.
Starting in the first week of October, the prescription-based eye drops will be available in pharmacies at a price of ₹350.
The medication is designed to treat mild to moderate presbyopia in individuals aged 40 to 55.
Entod Pharmaceuticals CEO Nikkhil K Masurkar said: “DCGI approval is a major step forward in our mission to transform eye care in India. PresVu has the potential to improve the lives of millions by offering them greater visual independence.”
On 4 September, the CDSCO issued a notice to Entod Pharmaceuticals regarding various claims made about Pilocarpine Hydrochloride Ophthalmic Solution in several news articles.
The company submitted its response on 5 September.
In response to the claim that PresVu is “the first eye drop in India designed to reduce the need for reading glasses.” The company stated in its reply that no other eye drops are currently approved for the treatment of presbyopia in India.
However, the CDSCO clarified in its order: “Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v has not been approved for any such claim that it is designed to reduce the need for reading glasses.”
Regarding the claim that “this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses,” the company submitted that participants in the clinical trial did not wear glasses during the study.
To this, the CDSCO responded: “Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v is approved for the treatment of presbyopia in adults, but it is not approved for the claim that these eye drops can enhance near vision without the need for reading glasses.”
In response to the claim that “PresVu can provide an advanced alternative that augments near vision within 15 minutes,” the company cited one doctor’s evaluation comparing the product to reading glasses.
The CDSCO reiterated: “Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v is approved for the treatment of presbyopia in adults, but it is not approved for the claim that PresVu can augment near vision within 15 minutes.”
In its 10 September order, the CDSCO stated that after reviewing the company’s response, it was evident that they had failed to adequately address the queries raised.
“You attempted to justify claims for the product without receiving the necessary approval. It is also clear that you did not obtain prior authorisation from the Central Licensing Authority to make such claims for the drug product in question,” the CDSCO noted.
The order further stated, “Thus, you have violated Condition No. (vi) of Permission No. MF/SND/24/000092, dated 20 August, 2024, granted for the manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v, under the provisions of the New Drugs and Clinical Trials Rules, 2019.”
The drug authority highlighted that, given the various media reports, there is a likelihood that the general public could be misled by the company’s unapproved claims.
“In view of the above, and considering public interest, Permission No. MF/SND/24/000092, dated 20 August, 2024, for the manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v, is hereby suspended until further notice, under the provisions of Rule 84 of the New Drugs and Clinical Trials Rules, 2019, of the Drugs and Cosmetics Act, 1940,” said CDSCO in the order.
(Edited by Muhammed Fazil)
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