PresVu was approved by CDSCO after deliberation for more than two years.
Ophthalmologists have criticised Entod Pharmaceuticals’ newly launched PresVu eye drops, which claim to eliminate the need for reading glasses, saying they are not a long-term solution and have several side effects.
India’s first eye drops that eliminate the need for reading glasses, PresVu, were approved by the Central Drugs Standard Control Organisation or CDSCO, the drug regulatory agency, last week after deliberating on it for over two years.
Though the drug received marketing approval from both the CDSCO and an expert committee after submitting data from a phase 3 clinical trial on over 270 patients, it has been plagued by controversies. A CDSCO official was quoted in the media as saying that the claims made by the company are unethical and a false presentation of facts. “This is an unethical and false presentation of facts,” the unnamed official told ANI.
However, the company has dismissed the allegations. “All the facts disclosed to the media are strictly based on the approved indication for the treatment of presbyopia in adults and the Phase 3 clinical trial data generated by us,” Nikkhil K Masurkar, CEO of Entod Pharmaceuticals, said in a statement.
PresVu is not a permanent solution
Experts say that for those who wear reading glasses, the prescribed dose is too small to last a day.
“A single drop a day will not be enough. One would need to apply the drop at least 4-5 times a day to have a sustained effect. And when the effects of the drops wear off, one will go back to using reading glasses,” Dr Uday Tekchandani, consultant ophthalmologist at Dr Agarwals Eye Hospital, told Times Now.
According to Dr Tekchandani, this is not a long-term solution to the problem of presbyopia. “So, is replacing glasses just for reading an option? Yes, but does it offer a long-term solution? No,” he added.
Entod says PresVu is specifically developed to reduce dependence on reading glasses in people affected by presbyopia, a common age-related vision problem that typically affects people over 40.
According to estimates, more than 1.5 billion people worldwide suffer from presbyopia, which doctors say is part of the natural aging process and not a disease. It is a common type of refractive error that eye care specialists can easily correct with glasses, contact lenses or even surgery.
May cause side effects
Dr. Tekchandai also said the eye drops caused side effects, including difficulty driving at night.
“These drops have their side effects, such as difficulty driving at night, the possibility of retinal tears and detachment. In addition, any eye drops can have side effects such as stinging and burning,” he added.
How does presbyopia manifest?
Doctors say the main signs and symptoms of presbyopia include:
- The need for more light when you are reading
- Blurry vision
- The need to keep reading material at arm’s length
- Headaches from doing work that requires a lot of attention
- Eye fatigue
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