Akums gets CDSCO Panel nod for Phase III CT of FDC Moxifloxacin, Nepafenac ophthalmic solution
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New Delhi: The drug major Akum Pharmaceutical has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial study of the fixed-dose combination of Moxifloxacin plus Nepafenac ophthalmic solution.
This came after the firm presented the revised Phase III clinical trial (CT) protocol and ocular toxicity study data of the Moxifloxacin plus Nepafenac ophthalmic solution.
Moxifloxacin is bactericidal, concentration-dependent, and anti-infective. It interferes with bacterial survival by binding to DNA gyrase (topoisomerase II) and topoisomerase IV, essential bacterial enzymes involved in the replication, translation, repair and recombination of deoxyribonucleic acid.
Moxifloxacin is used to treat certain infections caused by bacteria such as pneumonia, and skin, and abdominal (stomach area) infections. Moxifloxacin is also used to prevent and treat plague (a serious infection that may be spread on purpose as part of a bioterror attack.
Nepafenac eye drops are used to treat pain and swelling of the eye following cataract surgery. This medicine is a topical nonsteroidal anti-inflammatory drug (NSAID). This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: Suspension.
Nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
At the recent SEC meeting for Ophthalmology held on 23rd March 2023, the expert panel reviewed the Phase III CT protocol and ocular toxicity study data of the FDC Moxifloxacin plus Nepafenac ophthalmic solution.
After detailed deliberation, the committee recommended for conducting the Phase III clinical trial study. In addition, the expert panel suggested that the result of the study should be presented before the committee.
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