Investigational dry eye treatment moves to next phase

Alacrity Biosciences has announced positive results from a Phase II study of its treatment for dry eye, ALTY-0501.

ALTY-0501 is a proprietary topical formulation of 0.025% doxycycline in a non-antimicrobial dose, which acts to inhibit matrix metalloproteinase-9 (MMP-9). By inhibiting MMP-9, ALTY-0501 is thought to prevent the disruption of the epithelial barrier on the ocular surface.

The Phase II double-masked, randomized, parallel-group study enrolled 160 subjects to assess the safety and efficacy of the drug. Patients with dry eye were exposed to a controlled adverse environment on day one and asked to self-administer ALTY-0501 eye drops or vehicle eye drops four times a day. Patients were re-exposed to the controlled adverse environment on days 28 and 56. Environmental damage was assessed using fluorescein staining and symptoms were measured daily through patient diaries throughout the study period.

Patients who received ALTY-0501 demonstrated statistically significantly lower scores after fluorescein staining, following exposure, than the control group on day 28 (p<0.05). The drug also demonstrated statistically significant advantages compared with vehicle in the patient diary scores. 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 treatment group.

Alacrity plans to initiate Phase III trials early in 2008.