Aerie Pharmaceuticals (AERI) disclosed new details Thursday about the safety and tolerability of its experimental glaucoma eye drop Rhopressa. The data spooked investors, sending Aerie shares down 15%.
Rhopressa is Aerie's lead product and will be submitted for U.S. approval in the third quarter. But the drug's concerning safety profile, including elevated rates of eye redness, corneal deposits and blurry vision, could turn off doctors and glaucoma patients who already have access to cheaper and better-tolerated eye drops.
Aerie has previously announced results from two phase III studies comparing once-daily Rhopressa to twice-daily timolol, a generic glaucoma medicine. The studies demonstrated Rhopressa lowered intra-ocular eye pressure equally as well as timolol, with a "positive safety profile," according to Aerie.
New data disclosed for the first time Thursday show more glaucoma patients treated with Rhopressa experienced significantly higher eye-related side effects compared to timolol-treated patients in the two phase III studies.
When Rhopressa was given as a single dose, more than half of patients experienced conjunctival hyperemia, or eye redness, compared to 8% to 10% of timolol patients. More complaints of eye redness with Rhopressa occurred even though the drug is used before bedtime to minimize the impact of the side effect.
In addition, 9% and 5% of Rhopressa once-daily patients reported corneal deposits across the two phase III studies compared to 0.4% and 0% of the timolol patients.
Blurry vision was reported by 7% and 5% of Rhopressa patients compared to 3% and 0.5% of timolol patients in the studies.
The new Rhopress data are contained in a scientific poster being presented at the American Glaucoma Society annual meeting.
Arie shares are down $2.57 to $15.06 in Thursday trading. The stock has lost 38% of its value year to date.