Entod Pharma gets CDSCO Panel nod to conduct Phase IV CT of Atropine Sulfate Ophthalmic Solution USP 0.05%
New Delhi: Approving the proposal for a Phase IV clinical study for Atropine Sulfate Ophthalmic Solution USP 0.05% w/v, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) has recommended that Entod Pharmaceuticals Ltd. may conduct the study as per the protocol submitted.
This came after Entod Pharmaceuticals Ltd. presented their proposal to conduct a Phase IV Clinical Study of Atropine Sulfate Ophthalmic Solution USP 0.05% w/v, submitted under Protocol ID: BCREPL-004, Version 1.0 dated 17 July 2024.
Atropine is an alkaloid derived from Atropa belladonna. It is a racemic mixture of d- and l-hyoscyamine, with only l-hyoscyamine being pharmacologically active. Clinically, atropine is available primarily as a sulfate salt and can be administered through intravenous, intramuscular, subcutaneous, intraosseous, endotracheal, and ophthalmic routes. It is widely used in ophthalmology for pupil dilation and also plays an important role in managing anticholinergic poisoning and symptomatic bradycardia. Owing to its broad therapeutic applications, atropine is listed as an essential medicine by the World Health Organization.
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During the recent SEC meeting for ophthalmology, the committee reviewed the proposed Phase IV study design and safety assessment plan for Atropine Sulfate Ophthalmic Solution USP 0.05% w/v.
After detailed deliberation, the committee opined:
“The committee recommended approval to conduct the Phase IV Clinical Study as per the protocol presented by the firm.”
