Two late-stage trials identify safety issues for Aerie Pharmaceuticals new glaucoma treatment, Rhopressa.
Rhopressa (netarsudil ophthalmic solution) inhibits both Rho kinase and norepinephrine transporter and relaxes the trabecular meshwork to increase outflow and lower episcleral venous pressure.
Aerie previously announced that 2 phase 3 trials showed Rhopressa had a “positive safety profile” and had achieved its primary 90-day efficacy endpoint of non-inferiority compared to timolol.
But safety data from a poster abstract presented this month at the American Glaucoma Society’s annual meeting showed that patients treated with once-daily Rhopressa had elevated rates of eye redness, corneal deposits and blurry vision compared with twice-daily timolol.
In a table of adverse events, more than half of patients treated with once-daily Rhopressa experienced conjunctival hyperemia, compared to 8% to 10% of timolol patients. These complaints occurred even though the drug is used before bedtime to minimize the impact of its side effects.
In addition, 9% and 5% of Rhopressa patients reported corneal deposits compared to 0.4% and 0% of the timolol patients, across the 2 studies. Blurry vision was reported by 7% and 5% of Rhopressa patients compared to 3% and 0.5% of timolol patients in the studies.
This disparity in adverse events could turn off doctors and glaucoma patients. Aerie shares dropped 15% after release of the data. The stock has lost 38% of its value year to date.
In a response on March 17, Aerie provided additional details on the safety profile of Rhopressa. According to the press release, the majority of the conjunctival hyperemia cases were mild. While about half of Rhopressa-treated patients experienced hyperemia at some point in the trial, only 10% had hyperemia at each visit over the 12-month trial period. Other adverse events were typically sporadic or self-resolving.
"Consistent with what we previously reported, Rhopressa continues to demonstrate a positive safety profile after our deeper dive into the safety data. We believe Rhopressa, if approved, will be well-received by both ophthalmologists and the payer community. Our NDA filing remains on track for the third quarter of 2016," said Vicente Anido Jr., PhD, CEO at Aerie.