Article
Author(s):
Janet B. Serle, MD, discusses the pros and cons of various treatment options.
Reviewed by Janet B. Serle, MD
Physicians who treat glaucoma have several classes of effective topical treatments from which to choose, including branded drugs, generic drugs, and compounded medications, and the optimal choice for an individual patient may not always be obvious. Janet B. Serle, MD, professor emeritus of ophthalmology at the Icahn School of Medicine at Mount Sinai, New York, New York, walked physicians through the pros and cons of the various treatments.
Glaucoma causes changes in the ocular anterior segment that affect the trabecular outflow pathway. Physicians have access to new medications with mechanisms of action that directly affect the trabecular cells and outflow tissues to improve aqueous outflow.
The newest additions to the ocular hypotensive armamentarium are netarsudil (Rhopressa; Aerie Pharmaceuticals), latanoprostene bunod (Vyzulta; Bausch + Lomb), and a fixed-dose combination of netarsudil and latanoprost (Rocklatan; Aerie Pharmaceuticals), all of which enhance the ability of the trabecular meshwork to function properly.
Serle described a recent clinical trial (NCT03233308) showing that netarsudil enhances outflow facility and decreases episcleral venous pressure in patients with glaucoma, improving outflow through the proximal and distal portions of the outflow pathway.1
Phase 3 clinical trials have clearly demonstrated the efficacy of netarsudil and the fixed-dose combination as single therapies.2,3 Real-world studies provide information in a broader patient population, and in patients taking other medications to treat glaucoma. Two real-world studies have been conducted with netarsudil. The first study of 340 eyes of 233 patients demonstrated additional IOP reductions of 15% following addition of netarsudil. The IOP reductions were similar in eyes more than and fewer than 3 medications.4
A multicenter, open-label, phase 4 study5 (NCT03808688) of netarsudil included 242 of 261 patients enrolled. When netarsudil was added to a multidrug regimen, more patients achieved lower target IOPs than before netarsudil was added.
Latanoprostene bunod has been shown to enhance the outflow through the trabecular meshwork in ex vivo studies. In a retrospective real-world study, latanoprostene bunod achieved additional decreases in IOP of 2 to 2.5 mm Hg when the drug replaced a prostaglandin analog.6
Compounded medications
Compounded medications are not FDA approved but are compounded at facilities regulated by the FDA.
Serle identified 2 studies of compounded products in the literature. One study7 (NCT01217606) compared a dual fixed-dose combination drug with a triple fixed-dose combination (ie, respectively, brimonidine 0.2%/timolol 0.5% vs bimatoprost 0.01%/brimonidine 0.25%/timolol 0.5%). Both drugs were dosed twice daily. The patients who received the triple combination had greater IOP reductions at 12 weeks. However, Serle believes this did not confirm the benefits of the triple combination product because this may have been an unequal comparison; the triple combination contained a prostaglandin.
A second study (NCT01737853) compared a fixed-dose combination of 2 drugs compared with a fixed-dose combination of 3 drugs,8 respectively, bimatoprost 0.01%/timolol 0.5% dosed once daily and dorzolamide/brimonidine 0.15%/timolol 0.5% dosed twice daily. Both combinations were effective with slightly greater reductions in IOP in the combination containing bimatoprost. The message from this study is that for a patient who is intolerant of a prostaglandin analog, a triple combination may have sufficient efficacy in some patients compared with a dual combination, she said.
Generic and brand medications
Physicians likely prescribe more generics than branded medications because of lower cost and great availability of the former. The disadvantages of the generics are that the bottle design and dropper size can differ, based upon the generic manufacturer, making patient adjustment difficult; in addition, bioequivalence and not therapeutic equivalence is required for generic drug approval.
Serle concluded that many excellent ocular hypotensive therapies are available. She advised ophthalmologists to continue to use those that have proven to be efficacious over the years and to incorporate newer options into treatment plans, because certain patients may benefit from the newer agents.
Janet B. Serle, MD
E: janet.serle@mssm.edu
This article is adapted from Serle’s presentation at the American Society of Cataract and Refractive Surgery’s 2022 annual meeting in Washington, DC. She has no financial interest in this subject matter.
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