Alacrity Biosciences Announces Positive Results from a Phase 2 Study of Its Dry Eye Treatment... ( Phase 2 Drug Candidate Protects the...)

Alacrity Biosciences Announces Positive Results from a Phase 2 Study of Its Dry Eye Treatment ALTY-0501

Date:10/9/2007

Phase 2 Drug Candidate Protects the Ocular Surface Following Exposure to

Controlled Adverse Environment, Reduces Dry Eye Symptoms

LAGUNA HILLS, Calif., Oct. 9 /PRNewswire/ -- Alacrity Biosciences today announced that its dry eye treatment, ALTY-0501, demonstrated statistically significant advantages over vehicle in its ability to control signs and symptoms of dry eye in a Phase 2 study.

The Phase 2 study utilized the controlled adverse environment (CAE) chamber to measure dry eye patients' ability to withstand a stressful drying environment on the eye, and patient diaries to measure the severity of their dry eye symptoms over the course of the study. Patients were randomized to receive ALTY-0501 or its vehicle four times each day over the course of a 56 day study.

Patients who received ALTY-0501 demonstrated statistically significantly lower scores following CAE exposure for fluorescein staining of the total cornea-a measure of damage to the ocular surface-than those who received vehicle (p < 0.05) on day 28. Statistically significant differences from vehicle were also observed with total corneal and conjunctival staining (p < 0.05), superior corneal staining (p < 0.001) and nasal conjunctival staining (p < 0.05).

ALTY-0501 also demonstrated statistically significant advantages compared to vehicle in the patient diary scores measuring the severity of dry eye symptoms over the 56-day study period. Specifically, patient diary scores reflected statistically significantly lower scores for the symptoms of burning (p < 0.0001), stinging (p < 0.0001), and grittiness (p < 0.0001) in the active treated group.

"We have strong evidence that ALTY-0501 can help control patient signs and symptoms by maintaining the epithelial barrier on the surface of the eye," said David F. Power, Alacrity's president and CEO. "We plan to discuss the Phase 2 data and confirm our Phase 2b/3 strategy with the FDA in the fourth quarter of 2007. Our in
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Alacrity Biosciences Announces Positive Results from a Phase 2 Study of Its Dry Eye Treatment...( Phase 2 Drug Candidate Protects the...),Health