ENTOD Pharmaceuticals Receives DCGI Approval for PresVu Eye Drops: A Step To Manage Presbyopia

ENTOD Pharmaceuticals has achieved a significant milestone with the Drug Controller General of India (DCGI) granting final approval for its innovative PresVu eye drops. This development marks a  step forward in managing presbyopia, a common age-related vision condition that typically affects individuals over 40.

PresVu is the first eye drop in India specifically designed to reduce the dependency on reading glasses for people with presbyopia. The condition, which diminishes the eye’s ability to focus on nearby objects, is a natural consequence of aging and can have a substantial impact on daily life. Between 1.09 billion and 1.80 billion people worldwide are estimated to suffer from presbyopia, making this advancement particularly significant.

The proprietary formulation of PresVu has been developed after years of dedicated research by ENTOD Pharmaceuticals. The company has also applied for a patent for this invention, covering both the formulation and the process. The eye drops utilise advanced dynamic buffer technology, which allows the solution to swiftly adapt to the pH levels in tears. This ensures consistent efficacy and safety, which is particularly important for a product intended for long-term use. In addition to improving near vision, PresVu also offers the added benefit of lubricating the eyes, enhancing overall comfort.

Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals, said, “PresVu is the result of years of dedicated research and development. This DCGI approval is a major step forward in our mission to transform eye care in India. PresVu is more than just a product; it's a solution that stands to improve the lives of millions by offering them greater visual independence. We take pride in our commitment to innovation and in providing healthcare solutions that are both accessible and affordable.”

The approval from DCGI follows an earlier recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). This endorsement underscores the clinical potential of PresVu as a non-invasive treatment option for presbyopia. Dr Dhananjay Bakhle, a expert in the field, highlighted the significance of this approval, said, “the approval of PresVu is a promising development in the field of ophthalmology. For patients with presbyopia, this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses. Its rapid efficacy and safety profile, demonstrated in clinical trials, makes it a valuable addition to the treatment arsenal.”

PresVu’s ability to improve near vision within just 15 minutes of application represents a significant advance in presbyopia management. Traditionally, the condition has been managed with reading glasses, contact lenses, or surgical interventions. Dr. Aditya Sethi emphasised the patient benefits of this new treatment option, stating, “Presbyopia has long been managed with reading glasses, contact lenses, and surgical interventions but PresVu offers an advanced alternative that augments near vision within 15 minutes. This new treatment option is set to greatly improve the quality of life for many, allowing them to perform everyday tasks with newfound ease.”

As ENTOD Pharmaceuticals prepares for the commercial launch of PresVu, the company aims to drive innovation in the healthcare sector while supporting the 'Make in India' initiative. The introduction of PresVu is poised to set a new standard in eye care, offering hope and improved quality of life to millions affected by presbyopia.