The panel, in its meeting held on August 26, 2025, at CDSCO headquarters in New Delhi, directed the company to provide subgroup analysis, justification for drug inclusion, and dosing rationale before further consideration.
The committee specifically asked the firm to furnish a detailed subgroup analysis across different multicenters and clinical conditions, explain the inclusion of Moxifloxacin in all inflammatory cases, and justify the use of QID (four times daily) dosing for both Nepafenac and Ketorolac.
Additionally, the SEC sought clarification on whether patients prone to epithelial toxicity due to high NSAID dosages were excluded from the trial.
The proposal was submitted by Akums Drugs & Pharmaceuticals Ltd., a leading Indian contract research and manufacturing company with a wide portfolio of ophthalmic formulations.
The product under review is designed as a fixed-dose combination providing antibacterial and anti-inflammatory effects. While Moxifloxacin is a fourth-generation fluoroquinolone antibiotic used against bacterial eye infections, Nepafenac is a nonsteroidal anti-inflammatory drug (NSAID) prescribed for postoperative ocular pain and inflammation. Benzalkonium Chloride serves as a preservative in the solution.
The Phase III clinical trial report was presented in line with an earlier SEC recommendation dated March 23, 2023. However, the committee maintained that the above concerns must be addressed before progressing further.
After detailed deliberation, the committee opined:
The firm should provide detailed subgroup analysis for different multicenters and specific clinical conditions.
The firm should provide justification for the use of Moxifloxacin in all inflammatory conditions.
The firm should provide justification for using QID dose for both Nepafenac and Ketorolac.
High dosage of NSAIDs may lead to epithelial toxicity, the firm should clarify whether such prone cases were excluded or not.
"Accordingly, the firm should submit the above data for further review by the committee," the panel noted.
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