Drug regulator suspends product PresVu over unauthorised promotion

By Shalini Bharadwaj
New Delhi [India], September 11 : The Drugs Controller General of India (DCGI) on Wednesday suspended the product PresVu produced by Entod Pharmaceuticals after the company failed to respond to the queries on the product for which the DGCI says no approval was granted.
"Taking serious note of the unauthorised promotion of the product, PresVu (1.25% Pilocarpine w/v) by M/s Entod Pharmaceuticals Ltd, after getting permission from CDSCO to manufacture and market, the regulator has suspended their permission till further order. The unauthorised promotion in press and over social media had raised doubt on its unsafe use by patients and safety concerns for the public. The promotion raised concern about its use like OTC drugs, whereas it is approved as a prescription only drug," the Union Ministry of Health and Family Welfare said in a statement.
ANI reached out to the representative of the company regarding comments on suspension of product but received no response.
Earlier, ENTOD Pharmaceuticals had denied making any unethical or false presentation of facts to the media or public on PresVu eye drops.
Nikkhil K Masurkar, CEO, Entod Pharmaceuticals, said in a statement, "We at ENTOD Pharmaceuticals hereby declare that we have not made any of the unethical or false presentation of facts to the media or public when it comes to Presvu Eye drops. All facts disclosed to the media are strictly on the basis of the approved indication for treatment of presbyopia in adults and the phase 3 clinical trial data generated by us."
The company further mentioned that the opinions and claims printed in news reports do not represent ENTOD Pharmaceuticals, "Some of the opinions and claims printed in news stories do not represent that of ENTOD Pharmaceuticals or any of its spokespeople. The widespread media interest in such a therapy has been unprecedented and has led to sensationalization of the story."
However, the top official source from drug regulatory to ANI said that claims made by the company are unethical and a false presentation of facts. The company had been asked for an explanation for the false representation.
The company during the launch claimed, "PresVu is the first eye drop in India specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia, a common age-related vision condition that typically impacts those over 40. Presvu has also been applied for a patent for this invention in terms of its formulation and the process. The proprietary formula not only gets rid of reading glasses but also helps the patient lubricate their eyes as a side benefit."
"PresVu is the result of years of dedicated research and development. This DCGI approval is a major step forward in our mission to transform eye care in India. PresVu is more than just a product; it's a solution that stands to improve the lives of millions by offering them greater visual independence. We take pride in our commitment to innovation and in providing healthcare solutions that are both accessible and affordable," said Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals.
However, medical experts termed it an "imperfect and temporary solution".
"Pilocarpine eye drops have been used for glaucoma treatment since at least 75 years . They constrict your pupil, causing a pinhole effect, helping you to read. It is an imperfect and temporary solution for reading problems. Spectacles are perfect solutions," said Dr Charu Mithal, Senior Consultant, Dept. of Ophthalmology, Max Hospital Saket, New Delhi.
"Medical science has been advancing over the years. There are many trials that keep coming on the market from time to time. Some are very effective and safe, and sometimes they are very unsafe and very impractical. This drop, PresVu claims to clear your near vision, or what we call Presbyopia, which is the ability to read up close without glasses. This drop is nothing but pylocarpin in a different concentration," explained Dr Samir Sud, co-founder and director of Sharp Sight Eye Hospitals.
"Pilocarpine, how it works is that it causes constriction of your pupil and gives a pinhole effect. When the pupil has a pinhole effect, we can see distance and near without glasses. So that's how it functions. But like I said earlier, pilocarpine has some serious complications, so we don't know that after this trial, when it goes into masses, how it will behave in the eye, whether it will be safe or unsafe," Dr Samir Sud added further.
Dr Tushar Grover, Associate Consultant, Department of Ophthalmology, Sir Ganga Ram Hospital, said, "The drops recently introduced for correction of presbyopia are essentially pilocarpine eye drops at a relatively lower concentration. The molecule by itself is not new, and has been around for decades and used for treatment of glaucoma."