November 28, 2016
Ocular Therapeutix reported results of a phase III trial of Dextenza (dexamethasone insert) 0.4mg for the treatment of post-surgical ocular inflammation and pain. This prospective, multicenter, 1:1 randomized, parallel-arm, double-masked, vehicle-controlled study enrolled 438 patients who were undergoing clear corneal cataract surgery at 21 sites throughout the U.S. The trial successfully met its two primary efficacy endpoints for inflammation and pain, achieving statistically significant differences between the treatment group and the placebo group for the absence of inflammatory cells on day 14 and the absence of pain on day eight, respectively. Fifty-two point three percent of patients treated with Dextenza showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14, compared to 31.1% of those receiving the placebo vehicle control punctum plug (p<0.0001). Seventy-nine point six percent of patients treated with Dextenza reported absence of pain in the study eye on day eight, compared to 61.3% of those receiving the placebo vehicle control punctum plug (p<0.0001). Ocular Therapeutix has submitted an NDA to the FDA.
November 7, 2016
Aerie Pharmaceuticals reported results of a phase III trial of Rhopressa tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Rocket 4 enrolled approximately 700 patients and was a two-arm, six-month trial, which included a 90-day efficacy readout. The range for the primary endpoint includes patients with baseline IOPs from above 20mmHg (millimeters of mercury) to below 25mmHg. Rhopressa dosed once-daily achieved its primary efficacy endpoint demonstrating non-inferiority compared to twice-daily timolol for patients with baseline IOPs ranging from above 20 to below 25mmHg. Rhopressa also demonstrated non-inferiority compared to timolol at the pre-specified secondary endpoint range of above 20 mmHg to below 27 mmHg, and also at a range of above 20mmHg to below 28mmHg. The Rocket 4 efficacy results for Rhopressa demonstrated a consistent level of IOP lowering across all baseline IOPs in the trial, and throughout the 90-day efficacy period. There were no drug-related systemic or serious adverse events. Aerie has withdrawn the Rhopressa NDA that was submitted to the FDA in the third quarter of 2016. The filing was withdrawn as the result of a third party manufacturing facility in Tampa, Florida, not being ready for pre-approval inspection by the FDA. The drug product contract manufacturer has advised Aerie and the FDA that it expects to be prepared for FDA inspection in January 2017, and Aerie expects to resubmit the Rhopressa NDA filing at that time.
July 18, 2016
Valeant Pharmaceuticals International and Nicox announced results of a phase III study for latanoprostene bunod (LBN) ophthalmic solution 0.024% for open angle glaucoma (OAG) or ocular hypertension (OHT). The prospective, double-masked, parallel group trial compared LBN 0.024% with timolol maleate 0.5%. The results of this study showed that mean IOP was significantly lower in the LBN 0.024% group than in the timolol 0.05% group at all time points (range 17.7 - 18.7 mm Hg for LBN 0.024%; 18.8-19.6 mm Hg for timolol 0.5%; p≤0.025) except for week two at 8 a.m. (19.2 mm Hg for LBN 0.024% v. 19.6 mm Hg for timolol 0.5%; p=0.216). These differences corresponded to a reduction from baseline ranging from 29.1% to 32.1% in the LBN 0.024% group and 25.2% to 28.7% in the timolol group. Adverse events, though uncommon, were slightly higher in the LBN group. They included conjunctival hyperemia, eye irritation and eye pain, and were mostly mild-to-moderate in severity.
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.