Potential dry eye drug shows positive phase 2 study results

LAGUNA HILLS, Calif. — Alacrity Biosciences' dry eye treatment candidate ALTY-0501 showed a significant effect over vehicle for controlling dry eye symptoms in a phase 2 study, the company announced in a press release.

ALTY-0501 is a topical formulation of 0.025% doxycycline in a non-antimicrobial dose, which acts to inhibit matrix metalloproteinase-9 and is expected to prevent epithelial barrier disruption on the ocular surface, according to the release.

Investigators assessed dry eye symptoms in 160 patients randomly assigned to receive ALTY-0501 or vehicle four times daily. Patients were exposed to a controlled adverse environment chamber at study initiation and on days 28 and 56 of the 56-day trial.

At 28 days follow-up, patients receiving ALTY-0501 showed significantly lower scores for fluorescein staining of the total cornea compared with controls (P < .05). ALTY-0501-treated patients also had significantly lower scores for total corneal and conjunctival staining (P < .05), superior corneal staining (P < .001) and nasal conjunctival staining (P < .05), according to the release.

In addition, ALTY-0501-treated patients reported significantly lower scores for symptoms of burning (P < .0001), stinging (P < .0001) and grittiness (P < .0001) in their patient diaries.

"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, in the release. "We plan to discuss the phase 2 data and confirm our phase 2b/3 strategy with the [U.S. Food and Drug Administration] in the fourth quarter of 2007. Our intent is that these discussions will allow us to initiate phase 3 clinical trials early in 2008 with a clear path for regulatory approval."

Alacrity acquired worldwide rights to ALTY-0501 from the University of Miami when the company was formed in 2005, according to the release.