Sun Pharma obtains US FDA approval for BromSite
The US Food and Drug Administration (FDA) has given its approval for Sun Pharma's eye inflammation drug BromSite (bromfenac ophthalmic solution).
BromSite is the first non-steroidal anti-inflammatory drug (NSAID) to obtain FDA approval for the treatment of post-operative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
Developed by InSite Vision, BromSite is said to be the first bromfenac ophthalmic solution formulated in DuraSite, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies.
University of Minnesota Department of Ophthalmology adjunct professor Emeritus Dr Richard L. Lindstrom said: "Over the years, I've worked closely with the InSite team and watched them develop multiple high-quality products using the DuraSite platform.
"Today, I am pleased to see BromSite advance from development to market. I am confident there will be significant clinician interest in this new product.
"As the first NSAID labelled to prevent pain and reduce inflammation post-cataract surgery, BromSite's approval is timely and will be welcomed by patients and clinicians alike."
Sun Pharma acquired InSite Vision in November last year and is likely to commercialise BromSite through its newly formed, US-based division, Sun Ophthalmics, in the second half of this year.
BromSite joins Sun Ophthalmics' existing pipeline of pipeline candidates including Xelpros (latanoprost ophthalmic solution), which is being explored for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension, and DexaSite (dexamethasone) that is indicated for the treatment of blepharitis.
The efficacy of BromSite was evaluated in two multi-centre, randomised, placebo-controlled Phase III studies, in which a significantly higher proportion of BromSite treated patients were pain-free at day one post-surgery (77% and 82%) compared to patients treated with vehicle control (48% and 62%).
Additionally, a significantly higher proportion of subjects administered BromSite were inflammation-free at day 15 post-cataract surgery, compared to a vehicle control group.