Aldeyra plans reproxalap phase 3 after wrapping up dry eye disease trial

close-up of child's green eye
Shares in Aldeyra rose more than 30% in premarket trading following the news. (Rudy and Peter Skitterians)

Aldeyra Therapeutics’ reproxalap has improved ocular dryness and discomfort in patients with dry eye disease in a phase 2b clinical trial. The results tee Aldeyra up to move the aldehyde-binding small molecule into phase 3 next year.

Reproxalap, also known as ADX-102, is designed to reduce inflammation by lowering aldehyde levels. The hypothesis has taken some knocks in the clinic, but Aldeyra has seen enough promise to continue pushing ahead in some indications. Now, the Massachusetts-based biotech has data it's painting as evidence its efforts may be rewarded.

The information shared by Aldeyra leaves many questions unanswered, but the details the company has made available paint the results of the 300-patient phase 2b in a positive light. The clinical trial compared two doses of reproxalap to a placebo over 12 weeks.

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Patients who took the higher, 0.25% concentration of reproxalap experienced improvements on scores of ocular dryness and discomfort. Aldeyra’s release lacks a proper look at the data but does reveal the differences between the 0.25% reproxalap and control arms were statistically significant. The p values came in at under 0.05.

Aldeyra began to see improvements in the reproxalap arm at the first assessment, which took place two weeks after treatment began. The early onset of action is central to Aldeyra’s vision for how it will carve out a niche for reproxalap in a market fought over by Allergan’s Restasis and Shire’s Xiidra.

At this stage, it's unclear whether reproxalap has what it takes to disrupt the market. Aldeyra’s statement about the phase 2b revealed reproxalap bested placebo on an ocular fluorescein staining score, was well tolerated and exhibited a dose response, but otherwise was light on details.

Aldeyra has seen enough to set its sights on phase 3, though. The biotech is gearing up to talk with regulators about the study with a view toward initiating it next year.

Shares in Aldeyra rose more than 30% in premarket trading following the news.

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