Entod Pharma Management To Meet DCGI Officials To Discuss PresVu Suspension

The management of Entod Pharmaceuticals Ltd. plans to meet the Drugs Controller General of India to discuss the suspension of approval granted to the company to manufacture and sell its much-hyped eye drops, PresVu.

The company, which has decided to challenge DCGI's decision in court, will now clarify further on the claims made for PresVu, claims that DCGI labelled as false and unethical in its suspension order.

Expressing his disappointment over the ban on PresVu, Entod Pharmaceuticals’ Chief Executive Officer Nikkhil K Masurkar said that the company should have been at least asked for a meeting before imposing the suspension.

"We have just been slapped with an immediate suspension without any hearing or any opportunity to clarify further," he said in a recent interaction with NDTV Profit.

"But now, we have approached the DCGI for a physical meeting and we have got an appointment as well, where we will discuss all these issues in detail.".

However, the CEO refused to specify the date of its meeting with the DCGI and said that the meeting will take place “very soon.”

Earlier this month, Entod Pharmaceuticals got under the spotlight after it announced the launch of PresVu, which is said to be India's first approved eye drops to treat presbyopia, a common age-related condition of the eye that makes it difficult to focus on nearby objects.

At its launch, the company also claimed that the eye drops are an advanced alternative that augments near vision within 15 minutes and that they can enhance near vision without the need for reading glasses.

The DCGI denied the approval of these claims in an order on Sept. 11, as the company has failed to justify these claims. It added that there are chances that the public can be misled by such unapproved claims.

Further, such claims can also promote over-the-counter selling of drugs that can be consumed only on prescription.

However, the CEO said that these are not additional claims but are just a "layman explanation" to how this drug can treat a condition like presbyopia.

"We have decided to challenge this suspension in the court of law to get justice. We strongly desist this action," the company had said in a statement to the media.

"Whatever we have disclosed is clearly on the basis of approval from DCGI, which is the approval for treatment of presbyopia in adults and the third-phase clinical trials," Masurkar told NDTV Profit.

Sharing the specifics of clinical results behind each claim, the CEO told NDTV Profit that the subjects participating in the clinical trials were diagnosed with presbyopia but didn't use reading glasses during the trials.

Many of these patients were put on placebo, while the other half were treated with PresVu. Findings of the trial showed that the subjects being treated with PresVu could read "three additional lines" when tested after 30 days of treatment.

Hence, according to the company, PresVu can help in treating Presbyopia even for patients who are wearing reading glasses, reducing the need for spectacles.

On claims about PresVu augmenting near eye vision in 15 minutes, Masurkar said, "On what we saw in the clinical trial, 15 minutes was the first resting time when we saw the efficacy, and the onset of the action of Presvu is 15 minutes. This means that it starts working in 15 minutes; that is what the trial data showed."

Further, he said that all these results have already been submitted to the DCGI. However, when asked why DCGI would impose a suspension if they were aware that these claims were scientifically proven, Masurkar said, "I can't answer on behalf of DCGI. But all I can say is that whatever we have said was in line with the approval and is more of an explanation of presbyopia than an additional claim."

"A lot of concerns are raised because there were all kinds of claims made by the regional media, which talked about claims like 'good-bye glasses' and'miracle drops'," the CEO said, as he explained how media sensitisation on PresVu led to the ban on its manufacturing.

Meanwhile, Masurkar mentioned that there will not be any significant financial implications of the cancellation of PresVu and the product is yet to be manufactured for commercial use.

However, he said that PresVu can give a substantial boost to the company’s overall performance. Hence, no change in DCGI’s decision can be a missed growth opportunity for Entod.

On Entod Pharmaceuticals' future ventures, Masurkar disclosed that the company is working on newer products for the treatment of myopia in children and on treatment for glaucoma, corneal diseases and several other conditions, including retinal eye diseases.

Entod Pharma is also focused on the ear-nose-throat  dermatology segment and is developing nasal sprays, eardrops, topical neurotoxins, and dermal fillers, the CEO said.