Aldeyra's eye drug fails pivotal test in patients with rare, inflammatory disease
Months after eye drug developer Aldeyra Therapeutics tasted Phase III success, it has stumbled in another late-stage study with its lead experimental drug.
The eye drops, reproxalap, are designed to work by diminishing aldehyde levels, which can contribute to inflammation. In the Phase III SOLACE trial, the drug met neither the primary endpoint nor secondary goals in patients with noninfectious anterior uveitis — a rare, severe, ocular inflammatory disease that can lead to blindness. The Lexington, Massachusetts-based drug developer did not disclose the numbers.
“Statistical significance was not achieved for the primary or secondary endpoints, due to high rates of disease resolution in vehicle-treated patients, but activity of reproxalap was consistently greater than that of vehicle,” the company said, adding that it is abandoning the noninfectious anterior uveitis program.
Shares of the biotech $ALDX tumbled about 15.3% to $6 before the bell on Tuesday.
Reproxalap is also being evaluated for use in dry eye disease, for which Aldeyra kicked off the late-stage RENEW study this April. The drug conferred a statistically significant reduction in ocular itching in the Phase III ALLEVIATE study in patients with allergic conjunctivitis in March. Apart from eye diseases, the drug is also in late-stage development as a treatment for Sjögren-Larsson syndrome, a genetic disorder characterized by dry, scaly skin, intellectual disability, and spasticity.
In May, Stifel analysts estimated the noninfectious anterior uveitis opportunity is worth about $11 million, a mere fraction of the dry eye disease (DED) market.
Last month, Takeda $TAK sold its DED drugs, including Xiidra, to Novartis $NVS for $3.4 billion upfront (and $1.9 billion in sales milestones). Xiidra’s developer Shire — which was swallowed by Takeda this year — recorded sales of about $400 million in 2018.
“We think this speaks to the demand for novel DED drugs with long patent horizons,” Stifel analysts wrote. “(R)eproxalap has been dosed in over 700 patients across seven trials with no safety or tolerability concerns beyond mild, transient instillation site irritation. Comparable onset of action (effect seen as early as two weeks) to Shire’s Xiidra and a favorable safety profile to competitors Xiidra (discontinuation commonly caused by affected taste and blurriness) and Restasis (discontinuation from burning) leave reproxalap positioned well should it ultimately gain approval.”
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