This week, Mumbai-headquartered Entod Pharmaceuticals launched eye drops that can eliminate the need for reading glasses. India’s first eye drops to remove the need for reading glasses, PresVu, have been approved by the drug regulatory agency after deliberating on it for more than two years.
The medicine has received commercialisation approval from the expert committee and Central Drugs Standard Control Organisation (CDSCO) after submitting the data from a phase 3 clinical study on over 270 patients.
Nikkhil K Masurkar, chief executive officer (CEO) of Entod Pharmaceuticals, earlier told News18 in an exclusive interview that the drug will hit shelves in October and will be a prescription-based medicine.
The medicine is being pitched as a solution to remove reading glasses. However, multiple eye experts told News18 that in the real-world scenario, replacing spectacles with reusable eye drops may not be a good idea in the long run. They said that the drops can offer a stop-gap arrangement but not a lifetime solution or miracle cure.
How does the medicine work?
The medicine is made using ‘pilocarpine’ which has been used in the treatment of glaucoma for the last 75 years.
The medicine treats Presbyopia by reducing the size of the pupils which helps to see objects up close. Presbyopia is the age-linked decline in the ability of the eyes to focus on nearby objects and this condition typically becomes noticeable around the mid-40s and worsens until about the late 60s.
In healthy eyes, the clear lens behind the iris adjusts its shape to focus light on the retina, creating a clear vision for near-vision tasks. This accommodation is the ability of the natural lens in the eye to change its focusing power to see clear objects.
This accommodation is maximum at a young age but decreases with age, requiring near glasses with convex lenses to see fine print at 33/40cm. These eye drops improve visual clarity by modulating the pupil, creating a “pinhole effect” that increases the depth of field and improves the ability to focus on nearby objects.
In foreign countries, there are a few medicines for Presbyopia treatment, such as Orasis Pharmaceuticals’ Qlosi and AbbVie’s VUITY approved by the US Food and Drug Administration (US FDA). In 2021, VUITY was the first and only FDA-approved eye drop to treat presbyopia in the world.
Not a long-term solution: Experts
A single drop of the medicine starts working in just 15 minutes and its effects remain for the next six hours. If the second drop is also poured within three to six hours of the first drop, the effect will stay even longer, up to nine hours.
According to Dr Rohit Saxena from Dr Rajendra Prasad Centre for Ophthalmic Sciences at All India Institute of Medical Sciences, New Delhi, the drops are good for the short-term but do not offer a long-term solution.
“It is a temporary solution for reading problems as the effect of the drug will last for 4-6 hours and the drops will be needed 1-2 times a day lifelong,” he said.
“I would still consider spectacles as the preferred long-term solution as some side effects are also associated with the medicine, which include blurred distance vision, headache and rarely retinal detachment.”
Dr Digvijay Singh, head of the department, ophthalmology at Narayana Superspecialty Hospital, Gurugram, said the use of these drops is like flogging a tired horse. “The horse will run a little bit but eventually, it will tire off and fall.”
“Similarly, the drops will help for an interim period but eventually, the weakened muscles will tire out and you need to wear glasses,” he said, adding that these drops can work as a “stop-gap arrangement” but not as a “miracle cure”.
Dr Samir Sud, co-founder and director of Sharp Sight Eye Hospitals, believes that the usage of these drops is slightly “impractical” for the entire life and success of medicines in clinical trials is just half the battle won.
“We need to wait and watch how the drug behaves when it is used by masses. Also, it is quite impractical that you need to keep reusing the drops for its effects as it’s not a one-time solution.”
Sud explained that there are many other practical solutions such as multifocal lenses which give the same effect. “Only time will tell if these eye drops are useful for daily usage or not.”
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