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news.Aerie Pharmaceuticals (AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, has reported the successful results of its Phase 2b trial for once-daily, quadruple-action Roclatan, a combination of Aerie’s triple-action RhopressaTM with latanoprost, a prostaglandin analogue (PGA).
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Roclatan achieved its primary efficacy endpoint of statistically significant superiority over each of its components on day 29. The Phase 2b 28-day clinical trial included 297 patients. The baseline intraocular pressures (IOPs) tested in the study ranged from 22 to 36 millimeters of mercury (mmHg).
Roclatan lowered mean diurnal IOP on day 29 from 25.1 mmHg at baseline to 16.5 mmHg, a 34 percent decrease in IOP. Roclatan mean diurnal IOP reduction on day 29 was approximately 2 mmHg greater than latanoprost.
Roclatan efficacy exceeded that of latanoprost, the most widely prescribed glaucoma drug, by 1.6 to 3.2 mmHg across each time point evaluated during the study (8am, 10am, 4pm 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 Roclatan adverse event was hyperemia, or eye redness, which was reported in 40 percent of patients and was scored as mild for the large majority of the Roclatan patients.
In addition to the significant Roclatan findings, other performance highlights of the Phase 2b trial include:
On day 29, 50 percent of Roclatan patients compared to 28 percent of latanoprost patients experienced a 35 percent or greater decrease in mean diurnal IOP from baseline.
On day 29, 46 percent of Roclatan patients compared to 18 percent of latanoprost patients had a mean diurnal IOP of 16 mmHg or less.
The Rhopressa arm of the Roclatan study performed similarly to the results observed in the Rhopressa Phase 2b study, lowering mean diurnal IOP on day 29 by 6.3 mmHg from baseline.
"We are very impressed by the Roclatan Phase 2b results. 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 3 preparatory activities for Roclatan are commencing immediately. The entire Aerie team remains focused on moving forward towards Phase 3 registration trials for Roclatan, and initiating the Phase 3 registration trials for our other innovative product, triple-action Rhopressa," said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.