Fancy Your Chances?
Intracameral antibiotics reduce the risk of cataract complications – so why aren’t we using them?
John Berdahl |
Cataract surgery is the most common ophthalmological procedure in the world. And like all procedures, it has some risks – the worst being endophthalmitis. Endophthalmitis affects between 0.13 percent and 0.7 percent of patients (1) and can have devastating consequences, with some losing light perception all together. So what can we do about it?
The answer is intracameral antibiotics. In my mind, they’re one of the most important innovations in modern ophthalmology. Several studies have shown that intracameral antibiotics unequivocally decrease the incidence of endophthalmitis. But we’re not using them in the US.
Why? Firstly, there are no commercially available antibiotics for intracameral use in the US, so surgeons who want to use intracameral antibiotics have to be creative. Some take Vigamox straight from the bottle and inject it into the eye, others dilute it themselves – while others have their local hospital or pharmacy compound it for them. As you can imagine, this homemade approach has its flaws. There have been some isolated but well-publicized incidents where improperly mixed intracameral antibiotics have led to concentration errors. In some cases, toxic vehicles within the antibiotics have caused significant vision loss due to inflammation inside the eye. Vancomycin, one of the drugs associated with the procedure, has also been implicated in a condition called HORV – hemorrhagic occlusive retinal vasculitis. Although patients appear well after their first eye surgery, a very small subset begin to exhibit hypersensitivity after their second, experiencing bilateral retinal vasculitis and some even bilateral blindness.
These stories have made US ophthalmologists wary of intracameral antibiotics, even though the majority of us know that they are ideal for the prevention of endophthalmitis.
Right now, I use a non-FDA approved combination of FDA approved drugs, including dymethazine, moxifloxacin and ketorolac. They are all prepared under 503B manufacturing conditions, which means that the manufacturer, Imprimis, is FDA-inspected to the same high standards a traditional drug manufacturer, resulting in an exceptionally high quality product. To my knowledge, there have been no reports of improperly formulated medication.
The second reason US ophthalmologists are wary of intraocular antibiotics is cost. Compounded intraocular injections cost around $25 – and come directly from the surgery center or doctor’s pocket. In my mind, $25 is a small price to pay to guarantee a good outcome for my patients, but not every surgeon feels the same way. Part of the problem is that intraocular injections are considered part of the bundle of cataract surgeries, which means we can’t bill patients or insurance companies for individual treatments. Understandably, there are few people willing to invest dollars in the development of a technology that cannot return those dollars later down the line.
Europe has already proved the value of intraocular antibiotics in the clinical sphere – but in the US we need to put an economic engine behind it. The first step? Establishing a satisfactory reimbursement program. Fortunately, there are a number of groups encouraging the FDA and Medicare to collaborate on a solution. If they succeed and we find a way of returning investment, we can start the large-scale clinical studies needed to demonstrate the safety and efficacy of intraocular antibiotics.
I am hopeful that we will get an FDA approved antibiotic in the next few years. As with all new products, they will go through the natural innovation process before prices eventually settle. It is only then we’ll be able to provide real value to investors – and, crucially, to our patients too.
- N Mamalis et al., “Postoperative endophthalmitis”, Curr Opin Ophthalmol, 13:14–8 (2002). PMID: 11807383.2