PresVu Eye Drops: A Temporary Solution for Vision Correction or an Ethical Concern?

In India, millions of people over 40 wear reading glasses due to presbyopia, an age-related vision condition that affects near vision. With the introduction of PresVu eye drops by ENTOD Pharmaceuticals, many were hopeful for a revolutionary solution to reduce dependency on reading glasses. However, concerns have surfaced regarding the efficacy and ethics behind these claims, prompting further scrutiny from medical professionals and regulatory authorities.

False Claims by ENTOD Pharmaceuticals

ENTOD Pharmaceuticals has been asked to explain what regulators described as an "unethical and false presentation of facts" surrounding their PresVu eye drops. ENTOD had claimed that the drops, India's first of their kind for reducing the need for reading glasses, had received approval from the Drug Controller General of India (DCGI) and were a groundbreaking solution for presbyopia. However, these assertions have raised concerns about whether the public is being misled about the true capabilities and risks associated with the product.

What Exactly is PresVu?

The key ingredient in PresVu is pilocarpine, a drug that has been used for over 75 years in the treatment of glaucoma. Constricting the pupil creates a pinhole effect, temporarily improving near vision. While this mechanism may provide short-term benefits for reading, it is far from a permanent solution. I think glasses remain the most stable and long-lasting option for presbyopia, and PresVu is an "imperfect and temporary solution."

Limited Research and Side Effects

Though PresVu has been reformulated with a lower concentration of pilocarpine to reduce side effects, significant concerns persist. The drug's effect lasts only 5-6 hours, and it can only be used twice a day. Common side effects include headaches, eye irritation, redness, and strain. More severe complications, such as pupil muscle strain and potential challenges during eye surgeries like cataract or glaucoma treatments, have been flagged by experts.

Moreover, there is no long-term data on how PresVu may impact individuals, especially in the Indian context, where most people have brown eyes. Clinical trials conducted by ENTOD were performed primarily on individuals with blue eyes, leaving questions about the drug's effectiveness and safety for the Indian population unanswered.

Can PresVu be Sold Over the Counter (OTC)?

Given the risks and lack of long-term data, PresVu cannot and should not be sold as an over-the-counter (OTC) product. It requires a prescription from an ophthalmologist, who can monitor its effects on patients and ensure it is used safely. ENTOD's marketing pitch as a "solution for millions" must be tempered with caution and professional oversight.

Corrective Glasses vs. PresVu

Corrective glasses are the safest, most reliable, and long-lasting solution for presbyopia. Unlike PresVu, they do not come with side effects and provide stable, immediate vision correction without the need for ongoing applications or the potential for complications. Glasses are hassle-free, practical, and far more cost-effective in the long term, especially given that PresVu offers only a temporary improvement in near vision.

Ethical Concerns and Regulatory Scrutiny

The controversy surrounding PresVu is not just about its medical efficacy but also the ethical concerns raised by regulators. The Drug Regulatory Authority has asked ENTOD to explain its claims, particularly about portraying the drops as a long-term or permanent solution. Misleading patients into believing that PresVu is a magic bullet for presbyopia raises serious ethical questions, as does the lack of transparency regarding side effects and long-term outcomes.

Conclusion: A Temporary Fix, Not a Cure

While PresVu might offer short-term relief for certain patients, it is far from the revolutionary cure it has been marketed as. The drug's reliance on an age-old molecule with known side effects and its temporary efficacy makes it an imperfect solution. Corrective glasses remain the gold standard for those seeking a reliable, long-term option. As more data comes to light, particularly regarding its use among the Indian population, patients and doctors should approach PresVu cautiously and consider it a temporary fix rather than a permanent solution.

The ethical concerns regulators raise further underscore the importance of informed medical guidance and caution in adopting new treatments. Ultimately, the decision to use PresVu should be made in consultation with a qualified eye specialist, with all risks and limitations fully understood.

The article is written by Dr Jay Goyal, Eye Surgeon, LASIK, Retina Specialist, and Director at Surya Eye Hospital, Mumbai

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