Study: doxycycline better for dry eye than placebo

Laguna Hills, CA-The results of a phase II study show that Alacrity Biosciences' ALTY-0501 treats the symptoms of dry eye better than placebo.

The study involved a double-masked, parallel group. One hundred sixty patients with dry eye disease randomly received ALTY-0501 eye drops or placebo eye drops four times daily for 56 days. The patients were exposed to a controlled adverse environment on days one, 28 and 56. Researchers measured environmental damage to the ocular surface by using fluorescein staining.

ALTY-0501 patients relative to placebo patients had statistically significantly lower scores for fluorescein staining of the total cornea after exposure to the control on day 28. In addition, ALTY-0501 produced differences as compared with placebo in total corneal and conjunctival staining, superior corneal staining and nasal conjunctival staining.

Patients who received ALTY-0501 also had significantly lower scores for the symptoms of burning, stinging, and grittiness, according to the patient diaries.

"We plan to discuss the phase II data and confirm our phase IIb/III strategy with the FDA in the fourth quarter of 2007," said David Power, the company's chief executive officer. "Our intent is that these discussions will allow us to initiate phase III clinical trials early in 2008 with a clear path for regulatory approval."