CDSCO Panel nod for Clinical Trial of Ranibizumab Solution for Injection

Phase IV clinical trial will further investigate the safety and efficacy of Ranibizumab in specific patient populations and under various treatment regimens.

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CDSCO Panel
CDSCO Panel

Last Updated on November 12, 2024 by The Health Master

Clinical Trial

Sun Pharmaceutical Industries, a leading global pharmaceutical company, has received approval from the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase IV clinical trial for Ranibizumab Solution for Injection 10 mg/ml.

This approval marks a significant step forward in expanding the understanding and potential applications of this vital medication.

What is Ranibizumab?

Ranibizumab is a powerful biological therapy designed to target and neutralize Vascular Endothelial Growth Factor-A (VEGF-A), a protein implicated in the growth of abnormal blood vessels in the eye.

This innovative medication has been instrumental in treating a range of serious eye conditions, including:

  • Age-related macular degeneration (AMD): A degenerative eye disease that affects central vision.
  • Diabetic retinopathy: A complication of diabetes that damages the blood vessels in the retina.
  • Macular edema: Swelling in the macula, a part of the retina responsible for sharp, central vision.

How Does Ranibizumab Work?

By binding to VEGF-A, Ranibizumab effectively blocks its activity, preventing the formation of new blood vessels and reducing fluid leakage in the eye. This mechanism of action helps to stabilize vision and slow disease progression.

The Phase IV Trial

The newly approved Phase IV clinical trial will further investigate the safety and efficacy of Ranibizumab in specific patient populations and under various treatment regimens.

This additional research will help to optimize the use of Ranibizumab and potentially identify new treatment opportunities.

Sun Pharma’s Commitment to Innovation

Sun Pharma’s commitment to innovation and patient care is evident in its pursuit of groundbreaking therapies like Ranibizumab.

This latest approval underscores the company’s dedication to improving the lives of people with eye diseases worldwide.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.

  1. What is Ranibizumab?

    Ranibizumab is a medication used to treat various eye conditions, including age-related macular degeneration (AMD), diabetic retinopathy, and macular edema. It works by targeting a protein called VEGF-A, which is involved in the growth of abnormal blood vessels in the eye.

  2. What is a Phase IV clinical trial?

    A Phase IV clinical trial is conducted after a drug has been approved by regulatory authorities to gather additional information about its safety, effectiveness, and optimal use. It often involves larger patient populations and longer-term follow-up.

  3. Why is Sun Pharma conducting a Phase IV trial for Ranibizumab?

    Sun Pharma is conducting a Phase IV trial to further evaluate the long-term safety and efficacy of Ranibizumab, identify potential new uses, and optimize treatment strategies.

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