Sun Pharmaceutical Industries has received US Food and Drug Administration approval for an ophthalmic solution, used for preventing pain and treating inflammation in eye, after cataract surgery. The solution, BromSite, has been developed by InSite Vision, a specialty ophthalmic products firm bought by Sun last year.
The US FDA approval for the product is positive for Sun Pharma, which earns about half its consolidated revenue from the US. The firm has identified dermatology and ophthalmics as key segments to establish branded business in the US.
The US FDA approval for the product is positive for Sun Pharma, which earns about half its consolidated revenue from the US. The firm has identified dermatology and ophthalmics as key segments to establish branded business in the US.
It is likely to commercialise BromSite through its newly formed US-based division Sun Ophthalmics, in the second half of 2016.
BromSite is the first non-steroidal anti-inflammatory drug (NSAID) approved by the US FDA to prevent pain and treat inflammation.
According to IMS MAT January 2016, the US NSAID ophthalmic market grew eight per cent, generating approximately $400 million in sales and about four million prescriptions, providing an attractive market for Sun Pharma to participate, the company said.
Sun Ophthalmics has crossed a key business milestone through BromSite’s approval.
Sun Ophthalmics targets to provide eye care practitioners products that enhance their practice patterns and treatment options and to deliver those products through its unique, concierge level approach to customer care.
With BromSite’s approval and additional late-stage candidates in its pipeline, Sun Ophthalmics is strongly positioned to offer a range of beneficial products and establish itself as a respected and trusted partner, it said.