Launched in India: eye drop that can replace your reading glasses

An eye drop that can potentially replace reading glasses for middle-aged people was launched in India Tuesday, following marketing authorisation approval by the Drugs Controller General of India (DCGI) last month. This will be India’s first such eye drop. 

The drug contains 1.25 percent pilocarpine hydrochloride. Pilocarpine is a plant-derived compound that has been used for decades to treat various eye conditions and dry mouth, and reduce eye pressure, among other applications. 

It is meant to address presbyopia, a common age-related vision condition that typically impacts those over 40, causing the eyes to gradually lose their ability to focus on nearby objects. 

The eye drop has been developed and launched by Mumbai-based pharmaceutical firm Entod Pharmaceuticals under the brand name PresVu. A single vial of the eye drop, which is designed to last about a month, will cost Rs 345. 

A similar formulation was launched in the US in 2022 under the brand name Vuity, following regulatory approval by the US Food and Drug Administration (US FDA). Vuity is the only FDA-approved eye drop that can treat age-related blurry vision. 

Nikhil Masurkar, CEO of Entod Pharmaceuticals, told ThePrint that the eye drop’s launch in India is a result of extensive research that started in 2019. 

It is estimated, he added, that nearly 45 percent of Indians above the age of 40 years have presbyopia.

The drug is expected to be available in pharmacies across India by October, the CEO said.

Data from phase 3 clinical trials of the drug—carried out in 250 patients across 10 sites—submitted to the DCGI showed that it works best in people aged 40 to 55 years with mild-to-intermediate presbyopia, temporarily correcting vision problems.

The eye drop must be used only under prescription by an ophthalmologist. One drop of the drug should be put in each eye every day. The effect lasts about six hours. 

An additional drop can be put in each eye three-six hours after the first drop. This can potentially correct blurred vision for three more hours. 

Entod Pharmaceuticals claims that the drug starts working within 15 minutes of application but complete benefits are likely to be visible after 15 days of use.

Dr Dhananjay Bakhle, a senior pharmacologist and advisor to Entod Pharmaceuticals, said that for patients with presbyopia, the eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses. 

“Its rapid efficacy and safety profile, demonstrated in clinical trials, makes it a valuable addition to the treatment arsenal,” Bakhle told ThePrint. 

‘More suited for Indian eyes’

CEO Masurkar said that PresVu has adjuvants—components apart from the active pharmaceutical ingredient—different from the ones in Vuity. This is because Indians’ irises are typically more pigmented.

The company has also applied for a patent for the product in terms of its formulation and manufacturing process, and said that the proprietary formula not only allows patients to get rid of reading glasses, but also helps lubricate the eyes as a side benefit. 

“These eye drops utilise advanced dynamic buffer technology to swiftly adapt to tear pH (a scale used to measure how acidic or basic a substance is) ensuring consistent efficacy and safety for extended use, keeping in mind that such drops will be used for years at a stretch,” Entod Pharmaceuticals said in a statement.

Dr Aditya Sethi, a Delhi-based eye specialist, explained to ThePrint that while presbyopia has long been managed with reading glasses, contact lenses and surgical interventions, PresVu offers an advanced alternative that augments near vision within 15 minutes. 

“This new treatment option is set to greatly improve the quality of life for many, allowing them to perform everyday tasks with newfound ease,” Dr Sethi said.

The ophthalmologist added that it is important to monitor symptoms and seek medical advice if blurry close-up vision interferes with reading, close-up work, or other activities.

However, the Central Drugs Standard Control Organisation (CDSCO), headed by the DCGI, has not yet made public the approval letter granted for marketing authorisation of the drug. An approval letter for a drug mentions contraindications or possible adverse events associated with it. 

The CDSCO, while granting marketing authorisation to Entod Pharmaceuticals for PresVu, has asked for phase 4 data, which is collected after a drug is commercialised in the country. 

The US FDA lists possible complications associated with Vuity. 

The most common adverse reactions reported in less than 5 percent of clinical trial participants after using Vuity were headaches and conjunctival hyperemia or red eye. 

A few participants (1 to 5 percent) also reported side effects such as blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation (tear flow) after using Vuity. 

This is only for your information, kindly take the advice of your doctor for medicines, exercises and so on.   

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