Aldeyra Nabs Dry Eye Clinical Trial Win After Coming Up Short Previously

After failing to meet primary endpoints in earlier clinical trials for its dry eye disease treatment, reproxalap, Aldeyra announced it achieved two primary endpoints in a crossover trial. The Massachusetts-based company said reproxalap significantly outperformed the vehicle in ocular redness in a dry eye chamber and the regulatory standard Schirmer test. 

Working to Overcome Prior Struggles

Aldeyra has been working on reproxalap for several years as a treatment for dry eye disease, which affects approximately 39 million people adults in America. Reproxalap is a small-molecule modulator of reactive aldehyde species (RASP), which are molecules that can activate pro-inflammatory mediators. By inhibiting RASP, reproxalap has the potential to decrease excessive ocular inflammation associated with dry eye disease.

Reproxalap showed promise early on, prompting Aldeyra to further develop the drug in a landscape where dry eye treatments have long been considered unsatisfactory. In 2020, the company announced a strategic shift in its operations to focus entirely on eye diseases.

Since the shift, Aldeyra has been putting reproxalap through the paces in several clinical trials to push the drug towards approval. While the drug demonstrated optimistic characteristics in some areas, it was lacking in others. A Phase 2 study resulted in positive findings regarding the Schirmer test, which determines how much moisture and tears the eye produces, but it did not meet the primary endpoint of ocular redness. 

After missing its goal in the Phase 2 trial, Aldeyra modified its primary endpoints to include achievements in ocular redness or Schirmer tests above 10mm. Following the adjustment, Aldeyra announced findings from a Phase 3 trial which heralded reproxalap as a success when it demonstrated positive results in the Schirmer test. 

Now, Aldeyra’s most recent findings indicate that reproxalap achieved both primary endpoints for ocular redness and the Schirmer test in a 63-participant crossover trial. Aldeyra said patients experienced reduced ocular redness as soon as 10 minutes after administration of reproxalap. As with previous clinical trials studying reproxalap, Aldeyra found no significant safety issues.

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The Future of Reproxalap in a Crowded Dry Eye Market

AldeyraSince reproxalap is demonstrating the results Aldeyra always hoped it would, the company seems optimistic that despite its hurdles up to this point, reproxalap will make it to market to compete with other dry eye disease treatments. After studying the drug in over 1,800 patients, Aldeyra says it is scheduling a pre-New Drug Application (NDA) meeting with the FDA in the third quarter of this year to push it to the market. 

Several dry eye disease treatments are already approved and established in the US, like Novartis’ Xiidra, Sun Ophthalmics’ Cequa, and Allergan’s Restasis. Despite the number of options, patients and physicians express dissatisfaction with their choices and the ability to treat dry eye disease. 

More recently, Oyster Point Pharma’s Tyrvaya gained FDA approval as a nasal spray for treating dry eye disease. After the October 2021 approval, Tyrvaya resulted in $3 million in revenue in the first quarter of 2022 alone.  

If reproxalap is approved, it would be the first dry eye disease treatment approved based on more than one objective measure of success; improvement in ocular redness and positive Schirmer test levels. 

After experiencing some hiccups in middle-stage trials, reproxalap appears to have pulled through for Aldeyra in late-stage trials, setting the stage for potential approval in the future. Now that a lot of the heavy lifting is done, Aldeyra intends to work with the FDA to get the ball rolling on reproxalap’s NDA to see whether or not the rest of the dry eye disease arena will have another competitor in its midst. 

Author

Reed Slater