Last Updated on October 9, 2024 by The Health Master
New Delhi: Pharmaceutical major, Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a phase 4 clinical trial of Immunomodulator, Cyclosporine Ophthalmic Solution, which is used to increase tear production in patients with moderate to severe keratoconjunctivitis sicca (dry eye).
This came in line with the revised phase 4 clinical trial protocol presented by drug giant Sun Pharma at a recent SEC meeting for Ophthalmology.
Sun Pharma has launched Cequa, a cyclosporine ophthalmic solution, 0.09%, which is a calcineurin inhibitor immunosuppressant, belonging to the class, immunosuppressants.
The medicine is indicated for patients with keratoconjunctivitis sicca (dry eye), to effectively increase their tear production.
Dry eye diseases affect the ability of the eyes to produce their own tears. It is also used to treat vernal keratoconjunctivitis, an allergic eye condition.
Cyclosporine ophthalmic solution, 0.09% is supplied as a sterile, clear, colourless ophthalmic solution for topical ophthalmic use.
The drug is advised to be administered in one drop, twice daily, around 12 hours apart. It is put into each eye using a single-use vial.
The solution is suggested to be used immediately after opening, and the vial along with the remaining contents has to be discarded after use.
It is not approved for use by patients younger than 16 years old. Aqua is the first and only chronic dry eye treatment composed of NCELL Technology.
At a recent SEC meeting for ophthalmology, dated February 22,2022, the firm presented the proposal to conduct a Phase IV clinical trial of Cyclosporine Ophthalmic Solution 0.09% w/v as per the conditions of the import and marketing permission of the product before the committee.
After detailed deliberation, the committee granted permission to conduct the Phase IV clinical trial as per the protocol.
In addition, the committee suggested the firm submit the result of the Phase IV study for further review.
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