Pres Vu Eye Drop Licence Suspended —DCGI has withdrawn the approval of “Presvu Eye Drop,” suspending its license. The Subject Expert Committee of the Central Drugs Standard Control Organization was the first to recommend the product, after which Antode Pharmaceuticals got the final approval from the DCGI.
But the Ministry of Health and Family Welfare said yesterday that propaganda in the press and on social media raised doubts about the use of eye drops and safety concerns for the public. The widespread publicity of eye drops led to the danger of its use as an over-the-counter drug, even though it was approved as a prescription-only drug.
The regulator clarified that eye drops were not approved for any such claim. The CDSCO said it had issued a notice on September 5 seeking a response from Antode Pharmaceuticals on the matter. But he did not give the right answer, after which this action was taken. Nikhil Masurkar, CEO of Antod Pharmaceuticals, said they will challenge the suspension in court.
Dr. Saxena gave DGCI the report. He said that people in the US have been able to get it for three years. It was okay with DGCI. People said that this drug helped them see things close up. For 4 to 6 hours, this will let you see things clearly close. It did not help to turn away. It is too bad that the news about it made people think it was a magic drop. In this case, you will not need glasses. As the word got around, some people thought that their glasses would be taken off. There was no confusion at all, which is why DGCI has now put it on hold.
Pres Vu Eye Drop Licence Suspended By Drug Regulator
| Brand Name | Pres Vu |
| Manufacturer | Entod Pharmaceuticals |
| Approval | Drug Controller General of India (DCGI) |
| Active Ingredient | Pilocarpine |
| Purpose | Reduces dependency on reading glasses for presbyopia |
| Mechanism | Contracts iris muscles to improve focus on nearby objects |
| Technology | Advanced dynamic buffer technology |
| pH Adaptation | Adapts to the pH level of tears |
| Usage | Prescription-only |
| Duration of Effect | 4 to 6 hours |
| Side Effects | Itching, redness, eyebrow pain, muscle spasms in the eyes |
| Contraindications | Not for use in people with inflammation of the iris |
| Patent Status | Patent applied for formulation and process |
| Novelty | First of its kind in India for presbyopia |
| Research & Development | Years of R&D by Entod Pharmaceuticals |
| Additional Benefits | Lubricates the eyes |
| Onset of Action | Improves near vision within 15 minutes |
| Global Impact | Addresses a condition affecting 1.09 to 1.80 billion people globally |
| Age Group | Generally used by individuals above 40 years of age |
| Quality of Life | Enhances ability to perform everyday tasks without reading glasses |
What is presbyopia?
Presbyopia is a disease that gets worse with age that makes it harder to focus on things close up. Around age 40 is when most people start to have trouble seeing close up. One of the best ways to deal with the problem, according to doctors, is to wear glasses.
How does PresVu work?
What makes PresVu work is pilocarpine, a chemical substance that is part of medicines that do something to the body. Entod Pharmaceuticals says that the substance tightens the iris muscles, which control the size of the pupil and help people see clearly. This makes it easier for the eyes to focus on things that are close by.
Why do you worry about safety?
There were some possible side effects, just like with other drugs. Since it came out three years ago in the US, a lot of people have experienced side effects. If someone takes this medicine for a long time, they might get headaches or have trouble seeing far away. This is the reason why it can only be used with a prescription. When it becomes official in a few days, you should only use it after talking to an eye doctor.
The company’s claim is based on clinical trials. Masurkar said the approval given to the company was based on a validated controlled clinical trial conducted on 234 patients, which was successful in showing the efficacy and safety of eye drops in patients with presbyopia, who used these drops without glasses and could easily read Snellen’s chart.
Last week, Antode launched its Presvu eye drop made from pilocarpine, an alkaloid used to treat several ophthalmic conditions, including presbyopia. Presbyopia is an age-related eye condition that makes it difficult to see things up close.
