Sun Pharma secures CDSCO Panel nod to conduct phase IV Trial of Atropine Sulfate Ophthalmic Solution
New Delhi: Pharmaceutical major Sun Pharma has recently secured permission from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase IV Clinical Trial of Atropine Sulfate Ophthalmic Solution.
However, the expert panel has set condition that there should be increase in the sample size to cover for drop out.
This came in response to the Phase IV Clinical trial protocol presented by the drugmaker, Sun Pharmaceutical before the committee.
Atropine Sulfate ophthalmic comes as eye drops to instill over the affected eye as directed by physician. It belongs to a class of drugs known as anticholinergics and it acts by dilating the pupil of the eye. It is used before eye examinations (e.g., refraction) and also in the treatment of certain eye conditions such as uveitis.
In India, popular brand names of Atropine Sulfate Ophthalmic Solution include Atrisolon Eye Drops, Atroren-P Eye Drops, Atrosun Eye Drops , Topin Eye Drops.
At the 46th SEC meeting for Ophthalmology, held on June 25, 2021 at CDSCO, the CDSCO Committee extensively evaluated the protocol provided by Sun Pharmaceutical.
After detailed deliberation, the committee recommended grant of permission to conduct the Phase IV clinical trial as per the protocol presented subject to condition that there should be an increase in the sample size to cover for drop out.