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Once-daily netarsudil well-tolerated in glaucoma patients
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Researchers found in two randomized, double-masked clinical trials that once-daily dosing of netarsudil 0.02% was well tolerated for the treatment of ocular hypertension and open-angle glaucoma and non-inferior to timolol.
A total of 1,167 patients were enrolled in the ROCKET-1 and ROCKET-2 clinical trials and randomized to receive netarsudil 0.02% ophthalmic solution (Rhopressa, Aerie Pharmaceuticals) once daily, timolol twice daily and netarsudil 0.02% twice daily (ROCKET-2 only).
Once-daily netarsudil showed clinically and statistically significant reductions from baseline IOP and was non-inferior to timolol. Researchers also found that netarsudil twice daily was non-inferior to timolol but was not as well tolerated as once-daily dosing.
All three treatment groups produced statistically significant mean IOP reductions from baseline over the 3-month assessment.
Mean IOP in the netarsudil once-daily group ranged from: 16.7 mm Hg to 18.2 mm Hg; in the twice daily group: 15.7 mm Hg to 17.6 mmHg; and in the timolol group: 16.6 mm Hg to 17.7 mm Hg.
Adverse events in patients treated with once-daily netarsudil were mainly non-serious, generally mild in intensity and resulted in patient discontinuation from the study in 10% to 12% of participants, researchers wrote. The twice-daily dosing of netarsudil led to discontinuation in 30% of patients.
The most frequently reported adverse events were conjunctival hyperemia and conjunctival hemorrhage.
Researchers unexpectedly found that once-daily netarsudil 0.02% did not meet the criteria for non-inferiority to twice-daily timolol in the primary efficacy population of patients with maximum baseline IOP of less than 27 mm Hg. They are testing a hypothesis for this result in a follow-up phase 3 study, ROCKET-4, which includes subjects with baseline unmedicated IOP from greater than 20 mm Hg to less than 30 mm Hg. –by Abigail Sutton
Disclosures : The research was sponsored by Aerie Pharmaceuticals. Serle is a member of the Aerie Pharmaceuticals scientific advisory board and is a consultant to Bausch + Lomb and Allergan and receives research support from Allergan, Inotek and Ocular Therapeutix and is a stockholder in Aerie Pharmaceuticals. Please see the full study for all remaining authors’ financial disclosures.
Perspective
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Scott Anthony, OD, FAAO
We have a new drug class for treating glaucoma. In the past 10 years, advances in glaucoma treatments have mostly been surgical, so this is the most significant medical breakthrough we have seen since latanoprost was introduced.
Rhopressa (netarsudil ophthalmic solution 0.02%) was granted FDA approval in December 2017 and is planned to hit the market sometime in 2018. Optometrists must ready themselves to determine how Rhopressa will fit into their glaucoma treatment strategy.
What can we expect? On average, Rhopressa lowered the IOP up to 5 mm Hg in clinical trials. About half of patients have increased but painless conjunctival hyperemia once they start the drop. We will also likely see asymptomatic corneal verticillata and petechial conjunctival hemorrhages develop in some patients after extended use. It is currently approved for primary open angle glaucoma and ocular hypertension, so we will have to wait and see how it performs with other glaucoma types, just like we did when prostaglandin analogues entered the market.
Like any new drug class, it will take time and further study to better understand how Rhopressa will fit into our glaucoma treatment schemes. Nevertheless, this is a noteworthy advancement for any glaucoma practice.
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