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

PresVu eye drops, developed by Entod Pharmaceuticals, were launched with considerable media attention earlier this month as a novel solution for presbyopia. 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.

Entod Pharmaceuticals earlier announced that the product had approval from the Drug Controller General of India (DCGI). These announcements created substantial buzz, as the treatment promised a non-invasive solution to a common problem affecting millions of people.

Regulatory backlash

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.

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.

Entod Pharmaceuticals responds

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 eye drop, 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.

In a statement, Entod’s CEO, Nikkhil K Masurkar, clarified that the company had conducted phase 3 clinical trials in India to ensure the product’s safety and efficacy.
“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.

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.

"Such eye drops with the same active ingredient and same concentration have been approved by the US FDA 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.

Public and expert reactions

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.

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.
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.
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.