Rx Perspective

From ACME to Prolensa

By Robert Stoneback, associate editor

Modern NSAIDs have their roots in a landmark study that proved their effectiveness treating cataract patients. Without it, current NSAIDs like Prolensa (bromfenac ophthalmic solution, 0.07%, Bausch + Lomb) might not have been developed.

This 2008 study, investigated in part by the Acular LS for Cystoid Macular Edema (ACME) study group, examined the use of topical NSAID ketorolac in conjunction with a steroid on cataract surgery patients. When compared to a control group that received the steroid alone, the group that also received an NSAID had a much lower chance of developing CME and macular thickening following cataract surgery.¹

This proved that NSAIDs benefited virtually all cataract patients, according to investigator Damien Goldberg, MD, of Wolstan & Goldberg Eye Associates, of Torrance, Calif.

That group includes Prolensa, which received FDA approval in 2013 to treat inflammation and pain post-cataract surgery. And, like other NSAIDs, Prolensa’s use goes beyond cataract surgery.

“Unless there’s a known hypersensitivity to a nonsteroidal from past experience, then it’s potentially for every patient undergoing intraocular [surgery],” says Steven Silverstein, MD, of Silverstein Eye Centers in Kansas City, Mo. This includes transplantations and glaucoma, continues Dr. Silverstein, who was also an investigator in the ACME study.

Dr. Goldberg and Dr. Silverstein also participated in a study that investigated the efficacy of Prolensa for achieving zero-to-trace (0-5) anterior chamber cells after cataract surgery. In that study, 80.2% of the Prolensa group achieved that result, compared to 47.2% in the placebo group.²

“We were impressed with the result [from Prolensa] during cataract surgery. As soon as it came to market, we started using it,” says Dr. Goldberg.

Prolensa is a 0.07% bromenac ophthalmic solution used once daily following cataract surgery.

HALOGENATED ATOMS

While Dr. Silverstein says Prolensa’s capabilities are similar to other ophthalmic NSAIDs, he prefers Prolensa due to the halogenated bromine atom bound to the molecule. This increases the solution’s potency and lipophilicity, letting it more easily bypass the eye’s corneal barrier and reach the targeted tissues.

Prolensa has the lowest inhibitory concentration available in an NSAID, IC50, signaling its effectiveness.

While Dr. Goldberg prefers to use Prolensa in combination with an antibiotic and steroid to reduce complications, he knows some physicians prescribe only Prolensa following surgery. Based on Prolensa’s clinical outcomes, “I see why some surgeons feel confident making that choice,” Dr. Goldberg says.

Prolensa also has been tied to accelerated recovery from CME and faster postoperative recovery in general, according to Dr. Silverstein. While the speed of a patient’s recovery is dependent on many factors related to the surgery, many studies have demonstrated that benefits can start as early as the first day postsurgery, he says.

MORE CONVENIENT

The current form of Prolensa is a 0.07% bromfenac ophthalmic solution, designed for once daily use: the day before surgery; the day of surgery; and the next 14 postoperative days.

The fact that current NSAIDs like Prolensa only need to be used once per day is one of their biggest advantages.

The challenge with earlier NSAIDs was getting patients to use them; at the time of the ACME study, most topical NSAIDs had to be used four times a day and were much less comfortable for patients, according to Dr. Goldberg.

The 0.07% solution of Prolensa improves comfort for patients over the earlier 0.09% bromfenac version. The reason for this, according to Dr. Silverstein, is the 0.07% solution is more closely matched to the natural PH level of the eye. The more acidic or alkaline a product is, the more stinging sensation there is.

It’s another way that NSAIDs like Prolensa continue to improve over their predecessors. OM

Dr. Goldberg is an investigator for Bausch + Lomb; Dr. Silverstein is a consultant for Bausch + Lomb.

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