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BLOG: Steroid wars
The year 2019 is already shaping up to be one of intense competition between steroid products for use in eye surgery.
Of all the topical steroids prescribed today, about three-quarters are generic prednisolone acetate and about one-quarter are divided evenly between brand-name Lotemax (loteprednol, Bausch + Lomb) and Durezol (difluprednate, Novartis), according to industry sources. Generic prednisolone acetate has an outsize 74% share of the market despite its relatively high pricing; cash prices for this drug frequently are greater than $60 per bottle, which is sometimes more than the out-of-pocket coupon price for brand name steroids.
Competition this year will be driven mostly by new entrants to the market, though, including Inveltys from Kala Pharmaceuticals, which is loteprednol delivered in mucus penetrating particles that promise greater potency with less risk for steroid side effects. Bausch + Lomb, which owns the Lotemax franchise, has its own answer to Inveltys with a new, submicron formulation of Lotemax that is expected to be approved mid-year. With its new formulation, Bausch hopes to defend and expand its 13% steroid market share.
The unknown factor in these “steroid wars” will be new steroid delivery devices from EyePoint and Ocular Therapeutix. Both companies gained FDA approval for their offerings last year. EyePoint produces Dexycu, a cohesive liquid steroid depot that is delivered into the ciliary sulcus at the end of cataract surgery. This drug performed very well in clinical trials, in which our practice was involved. Routine patients can avoid topical steroid therapy altogether during their postoperative course. Pressure spikes with this dexamethasone product were no higher than placebo in the clinical trial, and our patients genuinely loved the reprieve from topical steroid therapy.
Ocular Therapeutix more recently obtained approval for Dextenza, another dexamethasone product. This hydrogel “punctal depot” device is inserted at the end of cataract surgery into the lower lid tear canaliculus, where it swells and comfortably remains in place for about 30 days as it delivers a tapering dose of dexamethasone adequate to control inflammation and provide an impressive safety profile, according to its clinical trial, which we also participated in.
It’s difficult to predict what part of the steroid market will be taken by these drop-free products, but in theory, they offer a significant advantage with pass-through reimbursement and no patient compliance issues.
What about NSAIDs? Will physicians prescribe fewer topical nonsteroidals if drop-free steroids are available to cataract patients? This remains a big question. Large studies have shown the additive value of NSAIDs in preventing cystoid macular edema compared with steroids alone, but these studies were generally conducted with topical drops in which patient compliance with four-time-a-day steroid dosing is not completely reliable. Repeating these studies with alternate drug delivery platforms such as Dextenza and Dexycu may yield a different result, making nonsteroidals nonessential for routine cataract patients.
While the competition between companies intensifies with all these new product offerings, both patients and surgeons are sure to win as new, more convenient methods of steroid drug delivery become common practice over the next year or so.
Disclosure: Hovanesian reports he has a financial interest as a consultant or investor to EyePoint, Ocular Therapeutix, Bausch Health, Allergan and Alcon.