Aldeyra's Reproxalap Falls Short in Anterior Uveitis Trial

Clinical Trial Data

Lexington, Mass.-based Aldeyra Therapeutics reported that its reproxalap failed to meet its primary or secondary endpoints in noninfectious anterior uveitis.

Uveitis is inflammation of the eye, which can cause vision loss. It causes about 10% of blindness in the U.S. Noninfectious anterior uveitis is a severe inflammatory eye disease that often occurs along with autoimmune diseases. It is marked by pain, sensitivity to light, redness, loss of vision, and other ocular symptoms.

The standard treatment is topical corticosteroids. However, extended use of corticosteroids increases the rate of cataracts and glaucoma in uveitis, and may increase the incidence of ocular infection, corneal ulceration, and other issues.

Attempting to put a positive spin on the trial, the company focused on other more positive trial data.

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“The results of the SOLACE Trial confirm the potential of reproxalap to treat ocular inflammation, and further validate the novel mechanism of action of reproxalap, which demonstrated highly statistically significant immune-modulating activity in the Phase III ALLEVIATE Trial and Phase IIb Dry Eye Disease trial,” stated Todd C. Brady, president and chief executive officer of Aldeyra. “We look forward to aggressively prioritizing advancement of high-value ocular programs in dry eye disease, allergic conjunctivitis, and proliferative vitreoretinopathy.”

In the SOLACE trial, the company did not provide data, but did state, “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.”

In this case, “vehicle” refers to placebo.

The drug was safe and well-tolerated.

The company expects to continue developing the drug for other indications but will terminate development for noninfectious anterior uveitis.

The news is likely a blow to investors. On June 21, ahead of the news, shares rose 4.71% to $7.33 in expectation that the company would report positive trial data. Analyst projections were so optimistic, they gave it an average price target of $28 per share, which would have been an increase of 281.99% from what the price was recently. Seemingly even the most skeptical brokerage firms still projected price targets around $20.

In September 2018, the company reported positive results from its Phase IIb trial of the drug in patients with dry eye disease. Patients receiving the 0.25% solution of reproxalap topical ophthalmic solutions compared to placebo showed statistically significant and clinically relevant reductions in the Four-Symptom Ocular Dryness Score and the Overall Ocular Discomfort Symptoms Score. Improvements compared to the placebo were consistently seen across all measures.

“Based on the successful Phase IIb results, we look forward to initiating a Phase III program in dry eye disease in 2019 following our discussion with regulatory authorities,” stated Brady at the time. “The addition of dry eye disease to our late-stage clinical portfolio, which includes Phase III clinical trials in allergic conjunctivitis and noninfectious anterior uveitis, highlights the potential of reproxalap as a highly differentiated and novel ophthalmic therapy.”

But not in noninfectious anterior uveitis.

In addition to developing compounds for immune-mediated eye diseases, the company has programs for systemic diseases, including reproxalap in Sjogren-Larsson syndrome, ADX-1612 in PTLD, mesothelioma and ovarian cancer, ADX-629 in autoimmune disease, ADX-1615 in autoimmune disease and cancer, and other compounds in systemic inflammatory disease.

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