This article is more than 5 years old. Information may no longer be current.
BLOG: What’s ahead in 2019
Click Here to Manage Email Alerts
If you want to know the future, look no further than the FDA’s coming Prescription Drug User Fee Act announcements calendar. While not all drugs reviewed by the FDA will obtain future approval, these are the dates that the FDA typically announces its decision whether or not to approve a new drug application. In ophthalmology, 2019 looks to be promising in glaucoma, macular degeneration and the treatment of anterior segment inflammation.
Aerie Pharmaceuticals has a PDUFA date of March 14 for Roclatan. This combination drug puts netarsudil 0.02%, the active ingredient in the company’s popular Rhopressa, in the same bottle with latanoprost 0.005%. The latter component is most commonly prescribed glaucoma drug in the U.S. FDA filings of this drug show that in glaucoma patients it consistently achieves lower pressures than either component alone. Outside of reimbursement issues that always accompany a new drug’s approval, this is likely to be a successful drug both because of its efficacy and its lack of beta blocker side effects.
In macular degeneration, Novartis’ brolucizumab is likely to challenge Regeneron’s Eylea (aflibercept) for market dominance in the anti-VEGF space. Eylea is currently highly popular because of its 8-week dosing regimen. However, phase 3 studies of brolucizumab have shown the product to compare favorably to Eylea with dosing every 12 weeks. Market research analysts suspect this drug could have sales exceeding $6 billion within a year or two of its approval. Retinal specialists, whose offices have been clogged with injection patients, certainly welcome the less frequent dosing.
Finally, one anti-inflammatory is likely to be approved in 2019. It is a new formulation of the familiar loteprednol molecule, which will now be delivered in a sub-micron formulation that should allow penetration through the ocular surface and greater potency than has been available with Lotemax gel (Bausch + Lomb) in the past. The drug is likely to be indicated for use in ocular surgery with three-times-a-day-labeled dosing, although it will probably work with twice-daily dosing off-label just as well. For us cataract surgeons, twice-daily dosing, which drives greater patient compliance, is highly desirable and has created the market for Novartis’ Durezol (difluprednate), a potent steroid in which twice-daily dosing works well, although many physicians fear the potential for Durezol to cause IOP spikes. The hope will be that a sub-micron formulation of loteprednol should have potency like Durezol with the safety profile of the gentler drug. Currently, Durezol and the approved version of Lotemax gel each enjoy about a 17% market share among U.S. topical steroids. The sub-micron formulation of loteprednol may well shift that balance.
Another anti-inflammatory that was just approved is not an eye drop at all. Dextenza from Ocular Therapeutix is a hydrogel that contains dexamethasone that is delivered as a depot to the lower punctum of the eyelid, where it expands and resides for about 1 month, slowly releasing this drug in a tapering fashion. FDA studies have shown 95% retention of the depot and a side effect profile (IOP spikes) similar to placebo. Naturally, avoiding steroid drops altogether is likely to yield the highest compliance among patients. Additionally, closing the punctum with this depot provides an ocular surface protective effect, allowing more tears to be retained in the eye after surgery, which benefits most patients.
Just as 2018 has been an exciting year in ophthalmology because of a large number of approvals, 2019 also promises to change the way we practice though new technologies that will benefit our patients’ lives.
Disclosure: Hovanesian reports he is a consultant for Novartis, Aerie, Bausch Health and Ocular Therapeutix.