ENTOD Pharmaceuticals Seeks Reinstatement of Approval for Its Eye Drops Following Suspension by DCGI

Mumbai-based ENTOD Pharmaceuticals is working with the Drug Controller General of India (DCGI) to address concerns over its recently approved Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25per cent w/v, branded as PresVu eye drops. Approved on August 6 for the treatment of presbyopia in adults, the drug's approval was suspended by DCGI on September 10 after healthcare professionals raised concerns.  

ENTOD's CEO, Nikkhil K Masurkar, clarified the situation, stating, "We met with the DCGI to discuss PresVu and explained our sincere intentions behind the media announcement. We fully understand the concerns raised and respect the decision to suspend the product after exaggerated claims appeared in the media. It is commendable to see such swift action taken in the public interest."

In a formal clarification, Masurkar emphasised that "PresVu eye drops are not intended to replace reading glasses or other non-invasive options for presbyopia. The product is a therapeutic option, available only by prescription from a registered medical practitioner, for patients diagnosed with presbyopia as evaluated by an eye doctor."

Further, Masurkar explained, "Our press conference was conducted in good faith, and while explaining the treatment, we discussed data from our Indian phase 3 clinical trial, particularly highlighting the 15-minute onset of action and the potential for reducing the use of reading glasses. Unfortunately, some of these statements were quoted out of context in news reports, which led to misconceptions that were never intended to be claims by our company."

Following discussions with the DCGI, ENTOD Pharmaceuticals has committed to ensuring strict compliance with all conditions outlined in the product’s approval. "We are issuing this clarification to the media and the public to prevent further confusion. As a responsible pharmaceutical company with nearly five decades of experience in ophthalmology, we prioritise regulatory compliance and trust with doctors, patients, and trade partners," added Masurkar.

Masurkar has also submitted a written undertaking to the DCGI, assuring full compliance with all approval conditions for PresVu eye drops and only making approved claims. The company has formally requested that the suspension be reconsidered.

Mohammed Kamil Khan, ENTOD’s Vice President of Marketing, also addressed the company’s future plans for the product, saying, "Any future launch of PresVu will include nationwide academic sessions for eye doctors, thorough training for field staff, and awareness initiatives to ensure the product’s prescription-only status is clear. We also welcome the decision of the apex body of ophthalmologists to develop clinical guidelines for this molecule in the treatment of presbyopia."

ENTOD Pharmaceuticals currently has over 150 ophthalmic formulations in the domestic market and supplies its products to 67 countries globally. The company’s R&D division is actively developing new treatments for eye conditions such as myopia in children, glaucoma, corneal diseases, and retinal disorders.