Sun Pharma’ BromSite Receives FDA Approval for Ocular Pain Treatment


sun pharmaIndian multinational pharmaceutical company Sun Pharmanon-steroidal anti-inflammatory drug (NSAID) BromSite received approval from the US Food and Drug Association (FDA). It is used for the prevention of ocular pain in patients undergoing cataract surgery and to relieve post-operative inflammations.

BromSite has been developed by US based InSiteVision, that was acquired by Sun Pharma in November 2015. Sun Pharma expects to commercialize the drug in the second half of the current year through its newly established US based division, Sun Ophthalmics.

Prolensa and BromdayBromSite is an ophthalmic solution of bromfenac. It is basically a combination of a low dose (0.075%) of the NSAID, bromfenac and InSiteVision Durasite®, which is a synthetic polymer based formula that has been so designed as to extend the time of the drug in the eye.

Before the FDA approval, BromSite underwent two Phase III trials that were conducted in more than 500 patients. In these trials BromSite achieved positive results of alleviating the inflammation and preventing the pain. The company defines the drug as an enhancement of the available treatments. Moreover, BromSite is the first NSAID for post cataract surgery conditions that has been approved by the FDA.

In this three and a half months of 2016 Sun pharma has constantly maintained itself in the news headlines with its partnership with AstraZeneca in Type 2 diabetes then by its entry to the Japanese market by acquiring 14 brands from Swiss firm Novartis and now the recent FDA approval for BromSite.

Apart from BromSite, following are the two other pipeline candidates of Sun Pharma in the field of eye care drugs:

  • Xelpros: a latanoprost ophthalmic solution that as at reducing the elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
  • Dexasite: it is dexamethasone and is still under experimentation to be able to treat Blepharitis

Of the joint ventures of Sun Pharma, the one is with Intrexon (US). The joint venture aims at working on RheoSwitch Therapeutic System technology that is expected to provide a targeted biological therapy without long term use of injections. In 2015, Sun Pharma generated a revenue of $4.5 billion and in the current financial year has till date generated a revenue of $24 billion.

Featured image credit: Cataract © rob3000 (Stock Photo ID: 75991913)

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