Pain-preventing NSAID welcomed by patients and clinicians

January 1, 2017

A new 0.075% formulation of bromfenac ophthalmic solution (BromSite, Sun Pharma) could provide relief from pain and inflammation associated with cataract surgery.

By Laird Harrison; Reviewed by Sheri Rowen, MD

A new 0.075% formulation of bromfenac ophthalmic solution (BromSite, Sun Pharma) could provide relief from pain and inflammation associated with cataract surgery, according to Sheri Rowen, MD, of Nvision Eye Centers, Newport Beach, CA.

Last April, the FDA approved the nonsteroidal anti-inflammatory drug (NSAID) to prevent pain and treat inflammation associated with cataract surgery, Sun Pharma announced.

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“According to the study data, it has good aqueous concentrations of the molecule after 1 drop,” Dr. Rowen said. “So that is an encouraging sign.”

Sun Pharma’s U.S. subsidiary, Sun Ophthalmics, began marketing BromSite in the United States last fall.

The agent delivers bromfenac in a synthetic polymer of crosslinked polyacrylic acid developed as DuraSite by InSite Vision. DuraSite is also the vehicle for Bausch + Lomb’s besifloxacin ophthalmic suspension (Besivance) and Akorn’s azithromycin ophthalmic solution (AzaSite).

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DuraSite is mucoadhesive and “can be used to improve solubility, absorption, bioavailability and residence time as compared to conventional topical therapies,” according to Sun Pharma. Sun Pharma of Mumbai, India, purchased InSite Vision of Alameda, CA, in November 2015.

The active ingredient is suspended in the DuraSite and is released in small doses each time the patient blinks, Dr. Rowen explained.

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The label calls for twice-daily dosing, morning and evening, beginning 1 day before surgery and ending 14 days after.

Bromfenac, the active ingredient of BromSite, inhibits cyclooxygenase (cox) 1 and 2, enzymes responsible for forming prostaglandins.

Phase III studies

 

Phase III studies

In two multicenter phase III, randomized clinical trials, a higher proportion of patients treated with BromSite were pain-free a day after surgery than patients treated with the vehicle alone, according to Sun Pharma.

In one study, 77% of the BromSite group was pain free versus 48% of the vehicle group. In the other, 82% of the BromSite group was pain free versus 62% of the vehicle group. The differences were statistically significant (p < 0.001).

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Likewise, a higher proportion of subjects administered BromSite were inflammation-free 15 days after cataract surgery compared to a vehicle control.

The proportions were 57% versus 19% in the first study (p < 0.001) and 38% versus 22% in the second study (p = 0.035).

Adverse reactions listed on the BromSite label include slow or delayed healing, an effect common to all NSAIDS.

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Dr. Rowen has just begun treating patients with the product, but so far has a good impression, she said.

“It’s very comfortable and interestingly enough it doesn’t have a prolonged blur, which was one of our concerns,” she said. “Vision seems to clear within a few blinks.”

Alternatives

 

Bromfenac is already available in a more standard vehicle in Bausch + Lomb’s Prolensa, which is approved to reduce (as opposed to prevent) ocular pain and treat inflammation associated with cataract surgery.

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Other alternatives include nepafenac ophthalmic suspensions by Alcon Laboratories in two concentrations: 0.1% (Nevanac, which is dosed three times daily) and 0.3% (Ilevro, which is dosed once daily).

Ketorolac is available as a generic for the same indication.

“You have to use it 4 times a day,” Dr. Rowen said. “It can cause corneal toxicity. It can sting quite a bit so patients end up not wanting to take it.”

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BromSite comes in a 5 cc bottle, which is larger than the bottle size for most competing medications, Dr. Rowen said.

Other medications in Sun Pharma’s pipeline include latanoprost ophthalmic solution 0.005% (Xelpros) for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, cyclosporine A 0.09% ophthalmic solution (Seciera) for the treatment of dry eye disease, and dexamethasone 0.1% (DexaSite) for the treatment of blepharitis. 

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Sheri Rowen, MD

E: srowen10@gmail.com

Dr. Rowen is a consultant for Sun Pharma.