Mumbai: India’s largest drug maker Sun Pharmaceutical Industries Ltd’s drug Seciera, indicated for the treatment of dry eye disease, has displayed positive results in a 12-week multicentre phase-3 clinical trial conducted on 744 patients, the company said in a stock exchange filing on Wednesday.
Seciera is a patented, novel, proprietary nanomicellar formulation containing 0.09% cyclosporine A in a clear, preservative-free, aqueous solution. Seciera is being developed by Ocular Technologies, a company that Sun Pharma recently acquired from Auven Therapeutics for an upfront payment of $40 million.
Following the acquisition, Sun Pharma owns exclusive, worldwide rights for commercialisation of the product and will make certain milestone and royalty payments to Auven.
The advanced randomized, double-masked, vehicle controlled phase-3 confirmatory study showed that Seciera met the primary and key secondary end points and the adverse events reported in the trial were mild to moderate in nature and similar to other approved drugs in the category, Sun Pharma said.
“We are happy to see the early onset of action and strong efficacy results for Seciera. We look forward to discussing these results with US FDA (US Food and Drug Administration) and agree on next steps for the program,” Dilip Shanghvi, managing director, Sun Pharma, was quoted as saying in the filing.
Dry eye disease, as defined by the National Health Institute (NHI), occurs when the eye does not produce tears properly, or when the tears are not of the correct consistency and evaporate too quickly. The market for dry eye drugs is expected to reach $5 billion by 2020.