ENTOD’s PresVu Eye Drops: India’s non-invasive answer to presbyopia or just overhyped?

ENTOD Pharmaceuticals has recently launched PresVu eye drops, which have been approved by the Drug Controller General of India (DCGI). Marketed as a potential breakthrough for presbyopia — a common age-related vision issue that makes it difficult to see up close — these drops are touted as an innovative alternative to reading glasses. However, despite the enthusiasm surrounding PresVu, there are mounting concerns regarding its safety and effectiveness. 

What is the product? 

The company claims that PresVu is the first non-invasive solution in India, offering an alternative to reading glasses by enhancing near vision. Additionally, these eye drops also serve as a lubricant for the eyes. ENTOD has indicated that it is seeking a patent for both the formula and the manufacturing process of PresVu. 

Presbyopia typically affects people over 40, making it challenging to focus on nearby objects. It is usually managed with reading glasses. It is widespread, impacting an estimated 109 to 180 million people globally. Although it is a natural part of ageing, it can interfere with daily life, making tasks like reading difficult. ENTOD’s eye drops aim to alleviate this issue by providing a more convenient alternative for those affected. 

According to Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals, eye drops utilise pilocarpine, a drug that has been extensively studied and used for decades, primarily in glaucoma treatment. Pilocarpine works by contracting the iris sphincter muscles, reducing the pupil size, and expanding the depth of field to improve near and intermediate vision. It also contracts the ciliary muscles, enhancing focus at closer distances. 

Until now, pilocarpine had not been available for treating presbyopia in India, according to ENTOD Pharmaceuticals. Masurkar noted that the drops should only be prescribed by an ophthalmologist following a proper diagnosis. The company claims the treatment is most effective for individuals aged 40 to 55, though its use must be based on expert evaluation. 

Clinical trials have demonstrated that the product is safe and effective, though no medication is entirely free of side effects. Approximately 2% of patients may experience minor issues like irritation or redness, but these typically resolve as the eye adapts to the treatment. 

Masurkar emphasised that pilocarpine eye drops are not a replacement for glasses. While they offer a non-invasive option for presbyopia, the effect is temporary, and patients may still need glasses over time. Clinical trial results will soon be published in a peer-reviewed journal, providing more data for doctors to guide their prescriptions. 

Mumbai-based ENTOD Pharmaceuticals further claims that the technology behind PresVu includes a dynamic buffer that adapts to the pH of tears, ensuring long-term effectiveness. This feature is essential as individuals may need to use the drops regularly for years. A single vial of PresVu eye drops will retail for Rs 345, making it affordable and accessible. Following the drug regulator’s approval, the company is gearing up for its commercial launch. 

Potential Side Effects and Reliability of PresVu 

Dr Jay Goyal, an eye surgeon and specialist in LASIK and retina treatments at Surya Eye Hospital in Mumbai, has expressed concerns about the hype surrounding PresVu. "The core drug pilocarpine in PresVu has been used for over 75 years, primarily for glaucoma treatment. However, it was eventually discontinued due to significant side effects," he said. 

The current formulation of PresVu uses a lower concentration of the drug to minimise these side effects, but they persist. Importantly, there is no long-term data available to confirm the safety or effectiveness of the drug over extended periods, he noted. The US Food and Drug Administration's (FDA) approval was based on a 30-day trial, leaving many questions about its reliability for long-term use. 

Dr Goyal supports corrective glasses as a better alternative, stating that glasses remain the most reliable and safe option for vision correction. "Glasses offer a stable, long-lasting solution without the risks or the need for frequent application like with eye drops. For individuals seeking a dependable, problem-free solution, glasses are still the best choice," he said. 

According to company's claims, PresVu’s effects begin within 15 minutes of application and its impact typically lasts for 5-6 hours allowing for twice-daily use. While the drops assist with short-term reading needs by constricting the pupil and enhancing focus, there is no evidence that they correct refractive errors in the long term. 

Dr Goyal pointed out that most clinical trials for PresVu were conducted on individuals with blue eyes, raising questions about its efficacy for those with brown eyes, which are more common in India. Side effects can range from mild headaches and eye strain to more severe conditions like retinal detachment in rare cases. He added that prolonged use may complicate future eye surgeries, including cataract or glaucoma procedures. 

Dr Goyal urged caution: "PresVu should only be used occasionally as a temporary fix. In the long run, patients will likely still need to rely on glasses." 

Experts Caution About Misuse 

Dr Sanjay Dhawan, CEO and Director of Medical Services at Indira Gandhi Eye Hospital in Gurgaon has raised concerns about the use of these eye drops marketed for presbyopia. The active ingredient in these drops, pilocarpine, has long been used to treat glaucoma by reducing eye pressure. However, one of its side effects — pupil constriction — has been repurposed to help people in their 40s and 50s see better up close. 

Dr Dhawan warns that while this side effect can improve near vision, the benefits are limited to a narrow age group and come with significant risks. "The improvement in near vision is temporary," he explained, "and is often accompanied by blurred distance vision, poor night vision, brow aches, headaches, and more serious issues like retinal detachment and allergic reactions." 

He also emphasised the importance of using such medications under the supervision of an ophthalmologist, warning that the marketing around these eye drops could lead to misuse. "The hype created by the company might encourage people to use the drug without understanding the risks. Manufacturers should be discouraged from promoting these drugs directly to consumers without appropriate medical advice." 

Dr Goyal echoed these concerns, stressing that PresVu should not be sold over the counter. "Given the potential risks and lack of long-term data, this should only be prescribed by an eye specialist after thorough evaluation," he stressed. He highlighted the importance of monitored use to avoid misuse, especially given the potential side effects.