Preliminary results from Aldeyra’s Phase III Tranquility trial offer promise for patients with dry eye syndrome

Aldeyra Therapeutics recently announced top-line results from the run-in cohort of the Phase III trial evaluating its product 0.25% reproxalap for patients with dry eye syndrome (DES). The positive impact of the therapy on endpoints, such as ocular dryness, discomfort and Schirmer’s test, although preliminary, signals an important advancement for DES patients compared to currently available treatment options, says GlobalData, a leading data and analytics company.

Reproxalap is a small molecule with a mechanism of action (MOA) that is novel for DES and one that is distinct from other anti-inflammatory MOAs currently seen in therapies that are approved for DES. It is an inhibitor of reactive aldehyde species (RASP), compounds that are understood to contribute to ocular inflammation and cause change in tear lipid composition. This anti-inflammatory action is in sharp contrast to that demonstrated by currently approved products, such as Allergan’s Restasis and Novartis’ Xiidra, both of which primarily interfere with the activation of T-cells.

Vinie Varkey, Senior Pharma Analyst at GlobalData, comments: “The preliminary results offer a glimpse into the potential of reproxalap to help improve signs and symptoms of DES. It will be crucial for the end results from these late-stage trials to replicate a similar trend in order to help establish this therapy as a first-line treatment for this indication. If the final results from late-stage trials evaluating reproxalap are able to demonstrate a significant improvement in signs and symptoms of DES, then the molecule is likely to have a unique differentiation from currently available therapies, that is in the form of a first-in-class aldehyde trap therapy for this indication.”

Although reproxalap represents a novel MOA for DES, the therapy can anticipate some challenge in the market as other pipeline agents are expected to enter the market.

Varkey adds: “The anticipated entry of other pipeline agents with other novel MOAs is likely to pose a challenge and can potentially limit the market share of reproxalap. Nonetheless, should any of these agents with novel MOAs receive approval and enter the market, it is expected to be a significant event that expands treatment opportunities for patients with DES.”

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