Ocular Hypertension

February 29, 2016

Aerie Pharmaceuticals reported results of a second phase III trial of Rhopressa (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. For the first 118 patients who reached the 12-month mark in Rocket 2, Rhopressa QD demonstrated a consistent level of IOP lowering at 8 am from day 90 through month 12, with a nominal variance of only 0.1 mmHg between day 90 and month 12. The first 118 patients on Rhopressa QD for the 12-month period demonstrated safety results consistent with those observed for the 90 day efficacy period. There were no new adverse events that developed over the 12-month period, and there were no drug-related serious adverse events. The most common adverse event was conjunctival hyperemia. Others included conjunctival hemorrhages, corneal deposits and blurry vision in 5% to 23% of the 118 patients. Increased hyperemia over baseline was observed by biomicroscopy at a rate of 30%, of which 76% was considered mild. Hyperemia was sporadic; 70% of patients with prior conjunctival hyperemia had no hyperemia at month 12. Rocket 2 will be supported by Rocket 1 for the NDA filing, expected to be submitted to the FDA in the third quarter of 2016. Rocket 3 is a 12-month safety-only study in Canada currently in progress but not needed for NDA filing. A fourth phase III trial, Rocket 4, commenced in late September 2015, and is designed to provide adequate six-month safety data to meet regulatory filing requirements in Europe. It is also not required for the NDA filing in the U.S.

May 18, 2015

Aerie Pharmaceuticals reported results of a phase III study of Rhopressa for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Rhopressa did not meet its primary efficacy endpoint of demonstrating non-inferiority of IOP lowering for Rhopressa compared to twice-daily timolol, based upon IOP measurements at the end of week two, week six and day 90. The Rocket 1 study included 182 patients in the Rhopressa once-daily arm and 188 patients in the timolol twice-daily arm. The baseline IOPs tested in the study ranged from above 20 to below 27mmHg. The results showed a slight loss of efficacy in the week six and day 90 measurements. Across the Rhopressa study of 182 patients, 36 patients or approximately 20% showed signs of loss of efficacy during the study. The primary adverse event was hyperemia, which was experienced by approximately 35% of the Rhopressa patients, of which 80% was reported as mild. Rhopressa demonstrated non-inferiority compared to timolol for patients in the study with IOPs below 26mmHg at all nine measured time points and numerical superiority over timolol at the majority of measured time points. The Baltimore Eye Survey points to approximately 80% of newly diagnosed glaucoma patients having IOPs of 26mmHg or less. Pending successful results from the remaining phase III registration trials and a potential additional phase III registration trial for Rhopressa, the company expects to submit an NDA filing by the end of 2016.

March 19, 2012

Bausch and Lomb and NixOx reported results from a phase IIb trial of BOL-303259-X for open-angle glaucoma or ocular hypertension. This trial enrolled 413 subjects who received various concentrations of BOL-303259-X or Xalatan 0.005% ophthalmic solution once daily for 28 days. The primary efficacy endpoint was the reduction in mean diurnal intraocular pressure (IOP) at day 28. BOL- 303259-X consistently lowered IOP in a dose-dependent manner. Two of the four doses tested showed greater IOP reduction compared with Xalatan 0.005%, with the differences reaching more than 1mmHg (p<0.01). The most efficacious dose of BOL-303259-X also showed positive results on a number of secondary endpoints, including consistently better control of IOP over 24 hours on day 28 as well as a statistically significant greater percentage of responders versus Xalatan 0.005%. The responder rate was 68.7% for the most efficacious dose of BOL- 303259-X, compared to 47.5% for Xalatan 0.005% (p≡0.006). The safety of BOL-303259-X was comparable to Xalatan.

February 18, 2003

The University of Arizona reported positive results from a post-marketing study investigating Lumigan (bimatoprost ophthalmic solution), a synthetic prostamide analog for the treatment of glaucoma. Results showed that the average reduction in eye pressure was greater for subjects treated with Lumigan than with the alternative medication, Xalatan (latanoprost ophthalmic solution). Nearly three times as many subjects failed to respond to Xalatan than to Lumigan at certain measured time points. In addition, subjects treated with Lumigan reached a significantly lower mean intraocular pressure level than subjects in the Xalatan group. Itching was more common in subjects treated with Lumigan, and ocular burning was more common in subjects treated with Xalatan. Eyelash growth and red eye were reported with both medications. The randomized, blinded study enrolled 269 subjects with ocular hypertension and/or glaucoma.

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