The Drugs Controller General of India (DCGI) has suspended the marketing approval of Entod Pharmaceuticals' PresVu eye drops following concerns that the company was aggressively promoting unapproved benefits of the drug. The suspension, effective immediately, was prompted by the company's claims that PresVu could reduce the need for reading glasses in individuals with presbyopia, a common age-related vision condition.
The DCGI issued a show-cause notice to Entod Pharma on September 4, after identifying instances where the company was overstating the drug's capabilities. Specifically, the regulator took issue with Entod's promotion of PresVu as the 'first eye drop in India designed to reduce the need for reading glasses.' According to the DCGI, the approved indication for Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v, the active ingredient in PresVu, is solely for the treatment of presbyopia in adults, and not for the reduction of dependency on reading glasses.
In response to the suspension, Nikkhil K. Masurkar, CEO of Entod Pharmaceuticals, stated that the company would challenge the decision in court. Masurkar maintains that all claims made about PresVu were based on the DCGI's approval for treating presbyopia and the results of a Phase 3 clinical trial conducted in India. The company argues that announcing the new product launch to the media is standard industry practice and that the subsequent public interest and media attention were beyond their control.
Concerns Over Pilocarpine Use
While Entod stands by its claims, several ophthalmologists have voiced concerns regarding the long-term safety and potential side effects of using pilocarpine to treat presbyopia. Pilocarpine, a cholinergic muscarinic agonist, has been used for decades to treat glaucoma but has largely been replaced by newer, more effective medications. One major side effect of Pilocarpine is miosis, or constriction of the pupil, which improves near vision but can also cause discomfort and other visual disturbances.
Sreeni Edakhlon, an ophthalmic surgeon, noted that pilocarpine-induced miosis typically lasts for 4 to 6 hours, requiring multiple daily doses to maintain the effect. This raises concerns about the long-term safety profile of continuous pilocarpine use, potentially spanning 35 to 40 years, given that presbyopia typically begins in the 40s. The All India Ophthalmological Society has formed an expert group to assess the potential adverse effects of PresVu and develop guidelines for its use.
Regulatory Scrutiny and Future Implications
The DCGI's decision to suspend approval for PresVu highlights the importance of adhering to approved indications and avoiding the overstatement of drug benefits. The case also underscores the need for ongoing evaluation of drug safety and efficacy, particularly when repurposing older medications for new uses. The outcome of Entod's legal challenge could have significant implications for pharmaceutical companies' marketing practices and the regulatory oversight of drug promotion in India.
