Developed in India: eye drops that can replace your reading glasses
New Delhi: An eye drop that can replace reading glasses for middle-aged people was launched in India on Tuesday, following the approval of marketing authorization by the Drug Controller General of India (DCGI) last month. This will be the first time that India has dropped its eyes.
The drug contains 1.25 percent of pilocarpine hydrochloride. Pilocarpine is a plant-derived compound that has been used for decades to treat various eye conditions and dry mouth, and to reduce eye pressure, among other uses.
It is intended to treat presbyopia, a common age-related vision condition that often affects people over 40, causing the eyes to gradually lose their ability to focus on nearby objects.
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Eye drops have been developed and launched by Mumbai-based pharmaceutical firm Entod Pharmaceuticals under the name PresVu. One vial of the eye drop, designed to last for about a month, will cost Rs 345.
A similar product was launched in the US in 2022 under the name Vuity, after regulatory approval by the US Food and Drug Administration (US FDA). Vuity is the only FDA-approved eye drop that can treat age-related blurred vision.
Nikhil Masurkar, CEO of Entod Pharmaceuticals, told ThePrint that the onset of eye drops in India is the result of extensive research that began in 2019.
It is estimated, he added, that about 45 percent of Indians above the age of 40 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—conducted in 250 patients across 10 sites—submitted to DCGI showed that it works well in people aged 40 to 55 with mild to moderate presbyopia, temporarily correcting vision problems.
Eye drops should only be used under an eye doctor’s prescription. One drop of the medicine should be put in each eye every day. The effect lasts about six hours.
Each eye can be instilled with each drop three to six hours after the first drop. This can correct the blurred vision for another three hours.
Entod Pharmaceuticals states that the medicine starts working within 15 minutes of use but the full benefits may be seen after 15 days of use.
Dr. Dhananjay Bakhle, chief pharmacist and consultant at Entod Pharmaceuticals, said that for patients with presbyopia, eye drops offer a non-invasive option that can improve vision without the need for reading glasses.
“Its rapid action and safety profile, demonstrated in clinical trials, make it an important addition to the treatment arsenal,” Bakhle told ThePrint.
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‘It’s better than India’s eyes’
CEO Masurkar said PresVu has adjuvants—other than the active pharmaceutical ingredient—that are different from Vuity. This is because Indian irises are often multi-colored.
The company has also applied for a patent for the product based on its design and manufacturing process, and stated that the material form not only allows patients to remove reading glasses, but also helps eye cream as a side benefit.
These eye drops use advanced buffer technology to quickly adjust the pH (the scale used to measure how acidic or basic a substance is) to ensure consistent performance and safety for long-term use, remembering that such drops will be used for many years, “Entod Pharmaceuticals said in a statement.
Dr. Aditya Sethi, a Delhi-based ophthalmologist, explained to ThePrint that while presbyopia has long been managed with reading glasses, contact lenses and surgical intervention, PresVu offers an alternative advanced that increases the vision for 15 minutes.
“This new treatment option aims to significantly improve the quality of life for many people, allowing them to carry out daily activities with new ease,” said Dr Sethi.
The eye doctor added that it is important to monitor symptoms and seek medical advice if blurred near vision interferes with reading, near work, or other activities.
However, the Central Drug Control Organization (CDSCO), headed by the DCGI, has not yet issued a license issued for marketing approval of the drug. A prescription for a drug mentions contraindications or adverse events associated with it.
CDSCO, while granting marketing approval to Entod Pharmaceuticals for PresVu, requested phase 4 data, which is collected after the drug is marketed in the country.
US FDA lists potential problems with Vuity.
Adverse effects reported in less than 5 percent of clinical trial participants after using Vuity were headache and conjunctival hyperemia or red eye.
A small number of participants (1 to 5 percent) also reported side effects such as blurred vision, eye pain, blurred vision, eye irritation, and increased fluid (flow of tears) after using Vuity.
(Edited by Radifah Kabir)
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