Dry eye treatment falls short of endpoint in phase 3 study

IRVINE, Calif. — A dry eye solution proved effective in treating a sign and symptom of dry eye but did not significantly outperform a placebo in a phase 3 study, Ista Pharmaceuticals announced in a news release.

Ista released results of the WEST study, the first of two randomized, double-masked, placebo-controlled phase 3 clinical trials designed to assess the short-term safety and efficacy of two concentrations of Remura (bromfenac ophthalmic solution).

Results showed that both concentrations of bromfenac and placebo yielded statistically significant improvement in a sign and symptom of dry eye disease from baseline (P < .0001). However, efficacy of the two dose levels of bromfenac did not exceed that of placebo, the release said.

The co-primary endpoints identified in a Special Protocol Assessment agreed upon with the U.S. Food and Drug Administration require Remura to achieve a statistically significant difference from placebo, not just from baseline.

However, the higher concentration of bromfenac attained statistical significance compared with placebo in the sign of conjunctival lissamine green staining among a sub-population of female patients between the ages of 51 and 70 years with moderate dry eye disease.

In addition, Remura was well-tolerated and had an adverse event profile similar to placebo and consistent with that observed in a phase 2 study and with other prescription dry eye drops.

The EAST and WEST studies are designed to enroll about 1,000 patients randomized 1:1:1 to receive one of the two bromfenac dose levels or placebo in both eyes, twice daily for 42 days. There was a safety follow-up visit 10 days after dosing was completed.

Patient enrollment for the EAST study is complete. Preliminary results of the EAST study are expected to be released in the fourth quarter, the release said.