In an earlier post I discussed the evidence that sutureless cataract surgery could leave the eye at risk for developing infection. Up until this week the only alternative to leaving the corneal incision as-is was to place a suture. Unfortunately, suturing takes additional time, adds cost, and can occasionally result in minor irritation or astigmatism. Thus, most surgeons do not bother with it (though I routinely place a suture at the end of my cataract surgeries).
Ironically, many surgeons even market sutureless cataract surgery as somehow advantageous to the patient – which I find frankly disingenuous. How can leaving an incision open to increased risk of bacterial entry (and vision-threatening infection) be beneficial to the patient? There may now be an opportunity for marketing hype to match real benefit to the patient with regard to closing the cataract surgery incision. Recently the FDA approved the use of ReSure® Sealant to prevent leakage from the cataract surgery incision. This is the first sealant to be approved by the FDA for eye surgery.
The study data presented to the FDA was impressive. Incisions closed with the ReSure® Sealant leaked less than 5% of the time. This compares very favorably to the “gold standard” of incision closure (suturing) after which the incision was noted to leak 35% of the time. Although I was surprised by the high percentage of leakage associated with suture closure in this study, I am excited about the availability of a new, seemingly more effective, and faster alternative to placing a suture at the end of cataract surgery.
Alas, one critical piece of information has yet to be disclosed by Ocular Therapeutix (the maker of ReSure® Sealant): the price. As is commonly known, one can only expect two out of the following three: cheap, fast, and good. As the ReSure® Sealant appears to be both fast and good, we can expect it won’t be cheap. Unfortunately, adding an expense to cataract surgery when surgery center reimbursement from insurance is anticipated to drop will be a tough sell with surgery center owners and administrators.
I don’t want to suggest that surgery center administrators are just being miserly here. As much as I would like to use the ReSure® Sealant on my patients, I have to admit that the cost might just be too prohibitive to be practical. The entire point of sealing the incision is to prevent bacteria from entering the eye. Bacteria cause infection (endophthalmitis) which can result in loss of vision or even blindness. The current rate of endophthalmitis in the USA ranges from 1 in 500 to 1 in 2,000. Let’s use 1 in 1,000 as an example. If the ReSure® Sealant were to half the rate of endophthalmitis a surgery center would have to use it on 2,000 patients in order to prevent one additional infection.
No one yet knows what the ReSure® Sealant will cost as Ocular Therapeutix has not disclosed pricing yet. Let’s assume, however, that bulk pricing is $50 per package (which is about 50% off the single-package pricing I’ve heard bandied about). The cost to the surgery center to prevent one additional infection would then be $50 x 2,000 = $100,000! That’s an expensive pill to ask a surgery center to swallow when Medicare and insurance will not reimburse the center any extra for using a more advanced or effective method of wound closure.
Hopefully Ocular Therapeutix will price the ReSure® Sealant well below what I’ve modeled above (though I wouldn’t bet on it). As a surgeon I’d love to have it available for my patients and I will be advocating for its use within the center in which I operate. If I’m given the opportunity to try it out I’ll update this blog with my experience.