Tuesday June 18, 7:31 am Eastern Time
Press Release
SOURCE: Inspire Pharmaceuticals, Inc.
Inspire Pharmaceuticals Announces Results of Second Phase III Trial of INS365 Ophthalmic for The Treatment of Dry Eye
Highly Statistically Significant Result Achieved on Primary Objective Endpoint Strong and Consistent Results Demonstrated on Multiple Subjective Endpoints
DURHAM, N.C., June 18 /PRNewswire-FirstCall/ -- Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH - News) today announced results of the second Phase III clinical trial for INS365 Ophthalmic for the treatment of dry eye.
Inspire will be holding a conference call/webcast at 9:00 am EDT. Participants in the United States may call 888-785-8522. Participants outside the United States may call 706-679-3437. The conference call webcast can be accessed from Inspire's website (http://www.inspirepharm.com).
This six-month study was a double-masked comparison of the safety and efficacy of INS365 Ophthalmic 1.0% and 2.0% eye drops to placebo. This study enrolled 527 patients at 34 sites across the United States. In this trial, 03-105, INS365 Ophthalmic 2.0% eye drops demonstrated a highly statistically significant improvement (p-value < 0.001) over placebo for the primary objective endpoint, corneal staining. As well as achieving statistically significant results at the primary 6-week endpoint, statistical significance was achieved as early as 2 weeks and was consistently observed throughout the 24-week study. This result is strongly supported by statistically significant results in other secondary objective endpoints such as conjunctival staining. These results are consistent with the results observed in the Phase II trial, 03-103.
The primary subjective endpoint for the study, clearing of the ocular symptom of foreign body sensation at six weeks, did not meet but approached statistical significance. The number of patients who cleared foreign body sensation was consistently higher on treatment compared to placebo throughout the study period. Moreover, there was a statistically significant improvement on this endpoint in favor of INS365 Ophthalmic at other time points for the greater than 80% of patients who complied with the protocol. In addition, INS365 Ophthalmic showed statistically significant improvements compared to placebo on various other ocular symptoms at multiple time-points.
INS365 Ophthalmic continues to demonstrate an excellent safety profile. Results from the safety analysis show a safety profile comparable to placebo. Of the 527 patients enrolled, 458 completed the study through 6 months. There were no serious drug-related adverse events reported in the study. There were more patient withdrawals due to adverse events in the placebo group than in either treatment group.
Importantly, Inspire also announced today that enrollment in the third Phase III pivotal trial, 03-108, is over one-third complete. This trial which compares placebo to INS365 Ophthalmic 2.0% was launched in April 2002 and is being conducted in a controlled adverse environment (CAE) that controls for factors such as humidity and involves precise measurements of patients' signs and symptoms of dry eye. As planned, to ensure that seasonal fluctuations in humidity do not impact the study, enrollment was halted for the summer months and will resume in the fall of this year. Top-line results from this trial are expected in the first quarter of 2003. |
