Pure & Cure Healthcare Gets CDSCO Panel nod To study Latanoprost,Netarsudil Mesylate Ophthalmic Solution

Published On 2022-10-16 07:59 GMT | Update On 2022-10-16 07:59 GMT

New Delhi: Pure and Cure Healthcare has got a go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct Phase III clinical trial of the proposed fixed-dose combination medication Latanoprost(0.0500mg) plus Netarsudil Mesylate(0.2mg) ophthalmic solution, used to treat elevated intraocular pressure (IOP) in people with...

This came after the firm presented the revised Phase III clinical trial (CT) protocol of the combination of Latanoprost(0.0500mg) plus Netarsudil Mesylate(0.2mg) ophthalmic solution along with the justification on ocular toxicity study data before the committee.

Latanoprost is a prodrug analog of prostaglandin F2 alpha that is used to treat elevated intraocular pressure (IOP). It was initially approved by the FDA in 1998.

Elevated intraocular pressure leads to an increased risk of glaucomatous visual field loss. The higher the intraocular pressure, the higher the risk of damage to the optic nerve and loss of visual field. Latanoprost selectively stimulates the prostaglandin F2 alpha receptor and this results in a decreased intraocular pressure (IOP) via the increased outflow of aqueous humor, which is often implicated in cases of elevated intraocular pressure.

Netarsudil is a rho kinase inhibitor used to reduce intraocular pressure in patients with open angle glaucoma or ocular hypertension. A Rho kinase inhibitor with norepinephrine transport inhibitory activity that reduces production of aqueous.

At the recent SEC meeting for the Ophthalmology held on September 22,2022, the expert panel reviewed the revised Phase III CT protocol of the combination of Latanoprost(0.0500mg) plus Netarsudil Mesylate(0.2mg) ophthalmic solution along with the justification on ocular toxicity study data.

After detailed deliberation, the committee noted that:

1. The individual drug was already approved on 1998 & 2020 by this office.

2. The product is already approved in USA.

In view of above, the committee recommended the grant of permission for conducting the Phase III CT study.

Also Read:Johnson and Johnson gets CDSCO panel nod to study Paliperidone Palmitate

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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Pure & Cure Healthcare Gets CDSCO Panel nod To study Latanoprost,Netarsudil Mesylate Ophthalmic Solution

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