Aerie Pharmaceuticals has reported successful results for a phase IIb trial for its IOP-lowering therapy-once-daily, quadruple-action Roclatan, a combination of Aerie’s triple-action Rhopressa with latanoprost.
Bedminster, NJ-Aerie Pharmaceuticals has reported successful results for a phase IIb trial for its IOP-lowering therapy-once-daily, quadruple-action Roclatan, a combination of Aerie’s triple-action Rhopressa with latanoprost.
"We are very impressed by the (trial) results,” said Vicente Anido Jr., PhD, chairman and chief executive officer at Aerie. “This product has demonstrated great promise to potentially become the most effective IOP-lowering product on the market, creating new hope for glaucoma sufferers. With this success we believe we have an approvable product, and phase III preparatory activities for (the therapy) are commencing immediately.
“With these strong data, we are even more confident that our products have blockbuster potential,” he added. “We continue to expect to market our products through our own sales force in North America, and plan to commence licensing discussions for commercialization outside of North America."
Highlights of the phase IIb trial results include:
· The therapy achieved its primary efficacy endpoint of statistically significant superiority over each of its components on day 29. The phase IIb 28-day clinical trial included 297 patients. The baseline IOPs tested in the study ranged from 22 to 36 mm Hg. The therapy also lowered mean diurnal IOP on day 29 from 25.1 mm Hg at baseline to 16.5 mm Hg-a 34% decrease in IOP. Mean diurnal IOP reduction on day 29 was about 2 mm Hg greater than latanoprost.
· Efficacy exceeded that of latanoprost by 1.6 to 3.2 mm Hg across each time point evaluated during the study (8 a.m., 10 a.m., 4 p.m. on days 8, 15 and 29). These results were statistically significant at all time points with p-values less than 0.05.
· The most common adverse event was hyperemia, which was reported in 40% of patients and was scored as mild for the large majority of the patients.
· On day 29, 50% of patients compared to 28% of latanoprost patients experienced a 35% or greater decrease in mean diurnal IOP from baseline.
· On day 29, 46% of the patients compared to 18% of latanoprost patients had a mean diurnal IOP of 16 mmHg or less.
· This arm of the study performed similarly to the results observed in the Rhopressa phase IIb study, lowering mean diurnal IOP on day 29 by 6.3 mmHg from baseline.
“These powerful data suggest that we are on the verge of a true breakthrough in IOP-lowering agents for the treatment of glaucoma,” said Richard L. Lewis, MD, a glaucoma specialist in Sacramento, CA, president of the American Society of Cataract and Refractive Surgery, and chairman of Aerie's Scientific Advisory Board.