On October 13th, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) discussed the new drug application (NDA 208254).
On October 13th, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) discussed the new drug application (NDA 208254) for Rhopressa™ (netarsudil ophthalmic solution) 0.02%, submitted by Aerie Pharmaceuticals Inc. The proposed indication for Rhopressa is to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
There were 2 voting questions and 1 discussion question posed to the committee concerning the efficacy, safety and proposed labeling of the product. The committee unanimously agreed (Yes: 10 No: 0 Abstain: 0) that the data support the efficacy of Rhopressa for reducing elevated IOP in patients with OAG or OHT. The committee members based their vote on the sponsor’s well-designed study, which produced meaningful clinical results. Although the committee agreed that Rhopressa demonstrated efficacy, some members expressed that it should only be used as adjunct therapy and in a subpopulation with a baseline IOP of less than 25mmHg.
The committee was then asked to vote on benefit-risk of Rhopressa. The majority of the committee agreed (Yes: 9 No: 1 Abstain: 0) that the efficacy of Rhopressa, as demonstrated in the clinical trials, outweigh the safety risks identified for the drug product. The one member who voted “No” expressed concerns with the high discontinuation rate shown in the trials and limited data on adverse effects of Rhopressa due to the short duration of the trial.
Regarding the labelling of the product, the committee suggested that side effects and warnings for pain/stinging at instillation site, corneal verticillate and conjunctival hyperemia be listed in the package insert. The committee highlighted that it is important to list corneal verticillate as a side effect, as it is typically asymptomatic, and may prevent clinical error such as misdiagnosis by non-ophthalmologists. It was also noted that listing pain upon instillation and conjunctival hyperemia in the label may prevent unwarranted drug discontinuation. The committee also noted that the high discontinuation rate of patients who used the product twice a day instead of once a day should dissuade practitioners from increasing the frequency and/or dose to maximize clinical outcomes. Overall, the committee members expressed that corneal verticillata, redness and pain upon instillation do not impact visual acuity, but the inclusion of these side effects in the label is warranted to promote awareness.
Rhopressa, if approved, will be the only once-daily product available that specifically targets the trabecular meshwork, the diseased tissue responsible for elevated IOP in glaucoma. Although the FDA is not obligated to follow the committee’s recommendation, the Agency typically takes its guidance into consideration when reviewing investigational medicines. The goal date for the FDA’s completion of the review of Rhopressa is February 28th, 2018.
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