Entod Pharma wins DCGI nod for PresVu eye drops to treat Presbyopia
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New Delhi: ENTOD Pharmaceuticals has received final approval from the Drug Controller General of India (DCGI) for its PresVu eye drops.. This approval follows an earlier recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
As per the company release PresVu is a eye drop in India specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia, a common age-related vision condition that typically impacts those over 40. The company informed that Presvu has also been applied for a patent for this invention in terms of its formulation and the process. PresVu contains 1.25 percent pilocarpine hydrochloride as the active pharmaceutical ingredient (API
According to a report, between 1.09 billion and 1.80 billion individuals globally are estimated to be affected by presbyopia. Its impact is both widespread and affects domestic productivity on a large scale. Presbyopia occurs as a natural consequence of aging when the eye’s ability to focus diminishes, leading to difficulty in focusing on close objects. This condition can significantly impact a person’s quality of life, affecting their ability to perform daily tasks and maintain their lifestyle. Many first notice presbyopia when they start holding reading materials at arm's length to see them clearly. A basic eye exam can confirm the diagnosis.
Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals, remarked, “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.”
Dr. Dhananjay Bakhle, commented on the clinical potential of PresVu, stating, “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.”
Dr. Aditya Sethi, emphasised the benefits for patients, adding, “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. It's important to monitor symptoms and seek medical advice if blurry close-up vision interferes with reading, close-up work, or other activities. Immediate medical attention is necessary for sudden blurred vision, flashes of light, or double vision.”
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