Dry eye treatment nearing approval

Article

ISTA Pharmaceuticals' dry eye candidate, ecabet sodium, has successfully completed Phase IIb testing and will soon be progressing to Phase III trials taking it a step closer to regulatory approval.

ISTA Pharmaceuticals' dry eye candidate, ecabet sodium, has successfully completed Phase IIb testing and will soon be progressing to Phase III trials, taking it a step closer to regulatory approval. Ecabet sodium combats dry eye by increasing mucin production.

Patients (n=144) were randomized to receive either ecabet sodium or placebo four times daily for 43 days. During the trial, patients treated with the compound demonstrated a strong trend towards improved results in terms of Tear Film Break-Up Time (TFBUT), tear production quantity and, to a lesser extent, Ocular Surface Disease Index (OSDI) symptoms. These objective and subjective positive trends were not observed in the placebo group. No systemic or ocular adverse events were noted in either treatment group. Patients displaying more severe symptoms of dry eye tended to respond better to ecabet sodium than to placebo.

ISTA Pharmaceuticals believes ecabet sodium improves both the quantity and quality of tears. ISTA is now considering four Phase III clinical trials to facilitate filing a New Drug Application (NDA) for this compound.

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