CDSCO Suspends Manufacturing and Marketing License of PresVu Eye Drops by Entod Pharmaceuticals

Suspension of Eye Drops

The Central Drugs Standard Control Organization (CDSCO) has taken decisive action against Entod Pharmaceuticals Ltd by suspending the manufacturing and marketing license for its eye drops, PresVu. This decision was made due to unauthorized promotional claims implying that the eye drops could reduce the need for reading glasses, which was not within the scope of its approved usage.

Concerns Over Unauthorized Promotion

On September 10, the CDSCO released an order clarifying that PresVu has only been approved for treating presbyopia in adults and cannot market itself as an alternative for enhanced near vision. Furthermore, it was not authorized to claim that it offers significant vision improvements within a short duration.

• The regulatory body expressed serious concern over misleading statements shared via press and social media.
• The promotional activities raised alarms about the product being positioned for over-the-counter accessibility, despite its classification as a prescription-only medication.

The drug regulator highlighted that they had issued this order to safeguard public health and requested Entod to provide clarification. However, the company's responses did not satisfy the regulatory body's concerns, leading to the suspension of their marketing license until further notice.

Clinical Trial Background

It is essential to note that the approval for PresVu was based on a controlled clinical trial involving 234 participants, demonstrating its efficacy and safety for patients with presbyopia. This clinical evidence affirms the value of PresVu in assisting individuals to read with fewer constraints imposed by eyeglasses.