NEW DELHI: India’s drug regulator has asked for an explanation from the Mumbai-based pharma company, which had claimed that their new eye drop could help people reduce dependency on reading glasses for those suffering from presbyopia, an age-related vision condition.
Official sources said the Drug Controller General of India (DCGI) had asked for a detailed explanation from ENTOD Pharmaceuticals about their claim that their eye drop PresVu, which they had described as an innovative and significant milestone in managing presbyopia. This common age-related vision condition typically affects those over 40 years of age.
The company claimed that the eye drop offers an advanced alternative that augments near vision within 15 minutes and received the Drug Controller General of India (DCGI) nod.
The company had also claimed that the approval follows an earlier recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
The minutes of the SEC held on March 27 say, “After detailed deliberation, the committee recommended grant of permission for manufacture and market of Pilocarpine Hydrochloride solution USP 1.25%w/v subject to the condition that the firm should conduct Phase IV clinical trial. In addition to the above, the firm should fulfil the requirements for CMC data. Accordingly, the firm should submit the Phase IV clinical trial protocol within three months from date of approval to CDSCO for further review by the committee.”
According to Kerala-based K V Babu, “No other minutes of SEC regarding the approval are available on the CDSCO website, and there is nothing to suggest that the pharma company submitted any long-term studies.”
“In this context, as an Ophthalmologist, I believe DCGI should put on hold its permission, if given to the company, to market the drug. The fraternity has also expressed concerns on this matter,” he told this paper.
The pharma company officials told TNIE that they contacted the DCGI and provided an explanation. Further details were not shared. Experts also said there are short- and long-term side effects of using eye drops, which the company has not shared.
In a written statement, its CEO, Nikkhil K Masurkar, told TNIE that they “hereby declare that they have not made any of the unethical or false presentation of facts to the media or public when it comes to Presvu Eye Drops.”
“All facts disclosed to the media are strictly based on the approved indication for treatment of presbyopia in adults and the phase 3 clinical trial data generated by us. Some of the opinions and claims printed in news stories do not represent those of ENTOD Pharmaceuticals or any of its spokespeople. The widespread media interest in such a therapy has been unprecedented and has led to the sensationalization of the story.
He further said ENTOD Pharmaceuticals is a 47-year-old research-based speciality pharmaceutical company with an excellent record of quality, innovation and research standards, and a trusted player in the pharmaceutical Industry.
“Over the years we have developed several cutting edge ophthalmic, ENT and dermatological medicines that have greatly contributed to therapeutic care in India,” the statement said.
According to Sunil Chakravarty, an eye surgeon with 45 years of experience in various government hospitals, this eye drop is not new as patients with glaucoma use it.
“The eye drop helps only for four to five hours to see better, and then it has to be used again. This medicine’s daily usage has short- and long-term side effects. The company has not mentioned any of these side effects. The immediate side effects are redness in the eye, pain, and headache, and the long-term usage could lead to pigment dispersion syndrome,” Chakravarty, a consultant ophthalmologist at Neptune Hospital, Delhi, said.
He said the company should not have come out with “false” claims about their medicine. “The choice to prescribe the medicine should be left with the doctors. The blanket usage of this medicine is not right.”
He also said occasional use may be ok, but regular use will be hazardous, whereas spectacles and multifocal contact lenses are affordable and safe.
Milind Pande, founder of CustomLensAi, added that the eye drops contain 1.25% pilocarpine hydrochloride, an old anti-glaucoma medication that is now being used for treating early and mild presbyopia. “It is claimed that this formulation was tailored for Indian eyes with higher iris pigmentation than Caucasian eyes. There has been a similar but exact replica preparation available in the USA for a few years now,” said UK-based Pande, the founder of Vision Surgery and Research Centre, with 42 years of experience in ophthalmology with expertise in cataract, cornea, and laser eye surgeries.
He also said using such treatments under medical supervision is essential.
