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Diquafosol enters phase 3 trials

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DURHAM, N.C. — Inspire has begun phase 3 trials of diquafosol tetrasodium for dry eye, the company announced in a press release.

The company received a letter from the Food and Drug Administration in December indicating that the drug is “approvable,” but an additional study providing evidence of efficacy was required, the press release from Inspire noted.

The new phase 3 trial is a double-masked, randomized, placebo-controlled safety and efficacy study of diquafosol 2% in patients with dry eye. The multicenter trial will enroll about 500 patients in 36 centers, Inspire said. The drug will be administered four times daily over a 6-week treatment period.