Sun Pharma Advanced Research Company Ltd. (SPARC), engaged in research and development of drugs and delivery systems, has received a Complete Response Letter from US FDA for its New Drug Application (NDA) for latanoprost BAK-free eyedrops.
While the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling and other deficiencies for processing the NDA. SPARC believes that this additional information request from the FDA can be addressed on priority.
Latanoprost BAK-free is a preservative-free, once-a-day formulation of the glaucoma medication Latanoprost using SPARC’s novel swollen micelle microemulsion (SMM) technology. Unlike conventional glaucoma eyedrops, latanoprost BAK-free does not cause or aggravate ocular surface disease (OSD).
Prostaglandin analogues like latanoprost are the first line of treatment for glaucoma. Market estimates place latanoprost usage at as high as 55 per cent of the US glaucoma market.
Swollen micelle microemulsion technology, or SMM, helps to solubilize drugs that have limited or no solubility, and cuts out the need for a preservative.