Aldeyra eyes its next phase

Aldeyra Therapeutics reckons it has put questions about the approvability of its dry eye disease project reproxalap to bed with its latest data drop. Indeed, the group described the results from a crossover study as “possibly the most important we’ve generated”. The trial entailed two days of either reproxalap or vehicle sandwiched either side of a two-week washout period – the idea being that patients acted as their own control, thereby cutting down inter-patient variability. And the crossover study achieved what Aldeyra’s pivotal trials, Tranquility and Tranquility-2, could not, by showing improvement on both ocular redness and tear production, measured by the Schirmer test. Still, the group’s stock opened flat this morning after being up as much as 14% premarket. Perhaps investors are unconvinced by the prospect of Aldeyra launching into a market dominated by Novartis’s Xiidra and Abbvie’s Restasis; the latter got its first generic competition in February. Aldeyra, which had $217m in the bank at the last count, hopes to submit reproxalap for approval this quarter following a pre-NDA meeting with the FDA. If the project is approved, the company will need to buck the trend of lacklustre launches for small developers.

Source: Company presentation

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