With its yet-to-be launched opthalmology product finding itself in the eye of a storm, Entod Pharmaceuticals top-brass said, their product is an approved, clinically tested, purely prescription-driven drug.
Earlier this week, Entod had said, it had received regulatory approval from the Drug Controller General of India for its innovative eye drops (PresVu), developed to reduce dependency on reading glasses for individuals affected by presbyopia. With the product slated for launch next month, caution was sounded by some eye-doctors on the use of Pilocarpine, used in the treatment of glaucoma and associated with side-effects including head-aches and retinal detachment.
Eye specialists said they were already being inundated with queries from people wanting to do away with their reading glasses.
Controlled launch
Responding to the interest in the product and concerns being raised by doctors, Nikkhil K Masurkar, Entod Chief Executive told businessline that the regulatory approval came in, following a review of data from its Phase III clincial trials. “The product is ...sold on the prescription of eye doctors, following diagnosis of presbyopia, as per the discretion of the doctor.” The October time-line stands, he said, adding that the product would see a controlled launch, with programmes to share their product-linked clinical trial data with eye doctors.
Clarifying on concerns raised by some doctors and reports of being asked for an explanation by the drug regulator on alleged misrepresentation of facts, Dhananjay Bakhle, Consultant Pharmacologist and Scientific Adviser for Entod Pharmaceuticals said the product is “repurposed pilocarpine, that means for a different indication, with a different strength.”
Besides, he added, the “drug used for glaucoma had a higher strength – so upto 4 per cent pilocarpine was used. Our product has 1.25 per cent and our product is given only once a day, pilocarpine for glaucoma is four times a day. ..it is one-16th the dose of pilocarpine that is used for glaucoma.”
Doctors confusing glaucoma with presbyopia are not aware there is a controlled clincial trial and after submission of data to the drug regulator and discussion by the Subject Expert Ccommittee, the approval was provided specifically for the indication of presbyopia.
“This drug cannot be used for glaucoma, and the glaucoma drug cannot be used for presbyopia – both being pilocarpines. Therefore, this is a completely different product compared to the product meant for glaucoma.,” he clarified. About 234 people were involved in the Phase III clincial trials, he said, adding that they showed mild side-effects like irritation or redness of the eye.
On whether the drug controller had sought an explanation, he said they were confidential and routine exchanges arising out of its approval involving details on the packaging information, product insert, etc.