Entod Pharma directed to submit results of Phase-IV CT protocol on 25 patients to continue manufacturing Cataract FDC
New Delhi: Manufacturer of fixed-dose combination drug Tropicamide/Phenylephrine/Lidocaine Intracameral solution for injection (0.2mg/ml + 3.1mg/ml + 10mg/ml), Entod Pharma has been directed by a Central Drugs Standard Control Organization (CDSCO) expert committee to submit the data of first 25 patients from the Phase-IV clinical trial for considering the continuation of the manufacturing permission.
This comes in response to the pharma company submitting its revised Phase-IV CT protocol for the drug.
Tropicamide (0.2mg) +Phenylephrine HCl(3.1mg) + Lidocaine HCL(10mg) solution is a fixed-dose combination solution, indicated for cataract surgery to obtain mydriasis and intraocular anesthesia during the procedure. It is recommended for intracameral (IC) use only in adults.
Tropicamide is an anticholinergic drug that induces mydriasis and cycloplegia by non‐selectively blocking muscarinic receptors. It helps to relax the pupillary sphincter muscle, resulting in pupil dilation. Phenylephrine is a direct-acting sympathomimetic drug that causes mydriasis by stimulating alpha-adrenergic receptors of the pupillary dilator. Lidocaine acts as a local anesthetic by reducing the ionic refluxes required for the initiation and conduction of impulses, thereby stabilizing the neuronal membrane. Two mydriatics, Tropicamide and Phenylephrine provide rapid, stable mydriasis for the duration of the cataract surgery.
The matter was brought up in 44th Subject Expert Committee (SEC) meeting held on 23.02.2021 & 24.02.2021 at Central Drugs Standard Control Organization (CDSCO), HQ New Delhi, where Entod Pharmaceuticals presented revised Phase-IV Clinical Trial protocol of Tropicamide/Phenylephrine/Lidocaine Intracameral solution for injection (0.2mg/ml + 3.1mg/ml + 10mg/ml).
The committee recommendation stated, "... for grant of permission to conduct the proposed Phase-IV Study with condition that firm should present results of first 25 patients from the Phase-IV clinical trial for considering continuation of the manufacturing permission issued to the firm."