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<keyword id="15160768" type="General" weightage="20" keywordseo="presvu" source="Orion">PresVu</keyword> eye drops, developed by <keyword id="20007796" type="General" weightage="20" keywordseo="entod-pharmaceuticals" source="keywords">Entod Pharmaceuticals</keyword>, were launched with considerable media attention earlier this month as a novel solution for <keyword id="23035383" type="General" weightage="20" keywordseo="presbyopia" source="keywords">presbyopia</keyword>. Presbyopia is a condition where individuals aged 40 and above experience difficulty focusing on nearby objects, often requiring reading glasses. PresVu claimed to reduce or eliminate the need for these glasses, offering an alternative through its active ingredient, 1.25% Pilocarpine, which temporarily contracts the pupil, improving near vision.<br /><br />Entod Pharmaceuticals earlier announced that the product had approval from the <keyword id="20047866" type="General" weightage="20" keywordseo="drug-controller-general-of-india" source="keywords">Drug Controller General of India</keyword> (<keyword id="20046022" type="General" weightage="20" keywordseo="dcgi" source="keywords">DCGI</keyword>). These announcements created substantial buzz, as the treatment promised a non-invasive solution to a common problem affecting millions of people.<br /><h2>Regulatory backlash</h2>The situation escalated when the Drug Controller General of India suspended the marketing and distribution licence of PresVu eye drops. The suspension was issued due to unauthorised promotional campaigns by Entod, which made unverified claims about the drug's capabilities. The company had reportedly promoted PresVu not as a prescription drug, but as an over-the-counter (OTC) solution that could potentially replace reading glasses — a claim that regulators found highly misleading.<br /><br />The DCGI expressed concerns that such promotions could lead to misuse, with patients potentially self-administering the product without medical guidance, raising significant safety concerns. Furthermore, the regulatory body pointed out that while the product had been approved as a prescription drug, the marketing blitz implied it was a quick-fix solution available to anyone, which it was not.<br /><h2>Entod Pharmaceuticals responds</h2>Entod Pharmaceuticals quickly defended itself against these allegations, maintaining that their marketing campaign was based on the information cleared by the DCGI. According to Entod, the promotion highlighted only the approved uses of the <keyword id="4537914" type="General" weightage="20" keywordseo="eye-drop" source="Orion">eye drop</keyword>, and any misconceptions arose from how the media and public interpreted the information. The company asserted that it would challenge the suspension in court, emphasising that other pharmaceutical companies frequently follow similar marketing practices without facing such scrutiny.<br /><br />In a statement, Entod’s CEO, <keyword id="21011592" type="General" weightage="20" keywordseo="nikkhil-k-masurkar" source="keywords">Nikkhil K Masurkar</keyword>, clarified that the company had conducted phase 3 clinical trials in India to ensure the product’s safety and efficacy.<br /><div type="Article" hostid="261" msid="113251803" title="The next big market for weight-loss drugs: children" mstype="2" mssubtype="0"></div>“Our approval by DCGI was based on a valid controlled clinical trial in 234 patients which was successful in showing efficacy and safety of these eye drops in patients of Presbyopia, who used these drops without eyeglasses and could read additional lines on Snellen's chart which is yardstick of near vision impairment,” Masurkar commented in a statement.<br /><br />He insisted that the product’s promotional activities had followed standard protocols and blamed the viral nature of media reports for blowing the issue out of proportion. Despite these defences, the product remained suspended pending further investigations.<br /><br />"Such eye drops with the same active ingredient and same concentration have been approved by the US <keyword id="19918726" type="General" weightage="20" keywordseo="fda" source="keywords">FDA</keyword> and marketed in the US for the last three years without any serious complications. FDA didn’t take any action on the companies marketing the same in the USA,” Masurkar further elaborated.<br /><h2>Public and expert reactions</h2>The controversy garnered widespread attention, particularly from medical professionals. The Liver Doc, a prominent liver specialist that takes to social media to debunk pseudoscientific claims, criticised the situation on X (former Twitter), warning about the dangers of exaggerated medical claims in advertising.<br /><br />The doctor’s tweet emphasised that blaming Indian media for blowing Entod’s claims out of proportion was “shameless”, noting that the media merely reported exactly what the company had themselves claimed earlier.<br /><div type="twitter" handle="theliverdr" handlename="theliverdr" favoritecount="0" retweetcount="0" id="1833828866210849170"></div>As of September 12, 2024, the suspension of PresVu's marketing approval remains in place. Entod Pharmaceuticals is preparing to contest the decision in court, hoping to reinstate its flagship product in the Indian market. The regulatory investigation continues, with the DCGI seeking clarification on the exact nature of the promotions and whether they indeed violated ethical standards.<br /><div type="Article" hostid="261" msid="113229771" title="China&amp;#39;s drug regulator clears mpox vaccine; to undergo clinical trial" mstype="2" mssubtype="0"></div>Despite Entod’s defence, the controversy has raised important questions about the marketing of prescription drugs in India, with regulators, the media, and the public closely watching how this case will evolve. The outcome could set a precedent for how pharmaceutical companies in India can market innovative treatments, particularly when dealing with sensitive areas like vision correction.<br />

PresVu eye drops: Why has a pharma company fallen in controversy for claiming to cure near-sightedness?

India is on the brink of a significant medical innovation with the upcoming launch of <keyword id="23029757" type="General" weightage="20" keywordseo="PresVu-eye-drops" source="keywords">PresVu eye drops</keyword>, a groundbreaking treatment aimed at reducing dependency on <keyword id="23034012" type="General" weightage="20" keywordseo="reading-glasses" source="keywords">reading glasses</keyword>. Developed by Mumbai-based <keyword id="20007796" type="General" weightage="20" keywordseo="Entod-Pharmaceuticals" source="keywords" meta.keywordsubtype="org" meta.entityname="Entod Pharmaceuticals" meta.hostid="261" meta.entityid="Entod Pharmaceuticals">Entod Pharmaceuticals</keyword>, PresVu has recently received approval from the Drug Controller General of India (DCGI) and is scheduled to hit the market in early October 2024.<br /><h3 style="line-height:1.2;margin-top:14pt;margin-bottom:4pt;">What is PresVu?</h3>PresVu eye drops are designed to treat <keyword id="23035383" type="General" weightage="20" keywordseo="presbyopia" source="keywords">presbyopia</keyword>, a common age-related condition that affects the eye's ability to focus on nearby objects. This condition, which typically begins in the early 40s, leads to a gradual decline in <keyword id="23035385" type="General" weightage="20" keywordseo="near-vision" source="keywords">near vision</keyword>, making reading glasses a necessity for millions. As per estimates, nearly one third of Indian adults suffer from the condition. PresVu offers a novel solution, aiming to restore visual independence to those suffering from mild to moderate presbyopia.<br />  <div type="Article" hostid="261" msid="112800837" title="Scientists want to help drug addicts recover — by giving them psychedelics" mstype="2" mssubtype="0"></div><h2>How does it work?</h2>The drug contains <keyword id="23035386" type="General" weightage="20" keywordseo="pilocarpine-hydrochloride" source="keywords">pilocarpine hydrochloride</keyword> — a plant-derived compound that has been used for decades to treat various eye conditions and dry mouth. The drops are intended for daily use, with effects lasting several hours, allowing users to perform tasks like reading without the need for glasses. As per the company, the effects of the drops will be apparent within 15 minutes, but complete benefits are only apparent after 15 days of use.<br /><br />The treatment has been thoroughly tested in clinical trials across India and has shown promising results in improving near vision.<br />  <div type="Article" hostid="261" msid="112738885" title="India bans 156 commonly used combination drugs citing possible risks to humans" mstype="2" mssubtype="0"></div><h2>Market impact and accessibility</h2>The introduction of PresVu is expected to make a significant impact in India, where the prevalence of presbyopia is rising. As per media sources, each vial will be priced at Rs 345, making it an affordable alternative to reading glasses. Each vial is designed to last about a month, making it a cost-effective solution for long-term use.<br /><br />Entod Pharmaceuticals has ambitious plans for PresVu, targeting not just the Indian market but also emerging markets in Africa and Southeast Asia. The company sees this as a step towards becoming a global innovator in ophthalmology, with future plans to out-licence products in the US market.<br /><br /><em>(Editor's note: PresVu eye-drops have since been suspended by the DCGI for making exaggerated marketing claims related to the product)</em><br />

Say bye-bye to reading glasses! Mumbai drug-maker to soon introduce eye drops to treat presbyopia in India

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PresVu eye drops: Why has a pharma company fallen in controversy for claiming to cure near-sightedness?

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Say bye-bye to reading glasses! Mumbai drug-maker to soon introduce eye drops to treat presbyopia in India

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