Sun Pharma Gets CDSCO Panel Nod to Study Cyclosporine Ophthalmic Solution
New Delhi: The drug major Sun Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of Cyclosporine Ophthalmic Solution 0.09%.
This came in line with the revised Phase IV clinical trial protocol presented by Sun Pharma before the committee.
Cyclosporine eye drops are used to increase tear production in patients who have a certain eye condition (eg, keratoconjunctivitis sicca). It is also used to treat vernal keratoconjunctivitis (allergic eye condition) and signs and symptoms of dry eye disease.
Cyclosporine is a potent immunomodulatory agent with an increasing number of clinical applications. Its major mode of action is inhibition of the production of cytokines involved in the regulation of T-cell activation. In particular, cyclosporine inhibits the transcription of interleukin.
Cyclosporine is a steroid-sparing immunosuppressant used in organ and bone marrow transplants as well as inflammatory conditions such as ulcerative colitis, rheumatoid arthritis, and atopic dermatitis.
At the recent SEC meeting for Ophthalmology held on 18th October 2023, the expert panel reviewed the revised Phase IV clinical trial protocol of Cyclosporine Ophthalmic Solution 0.09%.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase IV clinical trial as per the revised protocol (Protocol No. ICR/21/021, Version No. 2.0 Dated: 15.06.2023) presented by the firm.
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