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The bad first:
DRY EYE TREATMENT FAILS IN LATE-STAGE STUDY. Inspire Pharmaceuticals, Inc., says that compared with placebo, its dry eye treatment, diquafosol tetrasodium, did not significantly improve corneal clearing, the trial’s primary endpoint, in its six-week Phase III study. The compound also failed to reach secondary endpoints based on the Ocular Surface Disease Index, but its effect on corneal staining, conjunctival staining and conjunctival clearing was consistent with results of previous late-stage studies, according to Inspire. Patients using diquafosol tetrasodium reported burning or stinging more often than those using the placebo, but Inspire added that the incident rate was less than five percent. Based on these results, the company held a preliminary discussion with the FDA regarding the next step for the drug. Inspire intends to file a New Drug Application amendment for diquafosol tetrasodium by the end of this year’s second quarter.
And now the (potentially) good:
NOVARTIS LICENSES INVESTIGATIONAL DRY EYE TREATMENT. Novartis has in-licensed rebamipide, an investigational treatment for dry eye, from Japan-based Otsuka Pharmaceutical Company, Ltd. Rebamipide is currently being tested in two Phase III studies in the United States and is expected to demonstrate a novel mechanism of action to enhance tear secretion and increase the levels of mucin covering the conjunctiva and cornea. Under the agreement, Novartis will obtain an exclusive license with the right to sub-license the compound globally, excluding Japan and selected Asian countries. Novartis will pay an upfront fee and annual royalties. The terms of the agreement were not disclosed.
Keep those fingers crossed, my friends...
DRY EYE TREATMENT FAILS IN LATE-STAGE STUDY. Inspire Pharmaceuticals, Inc., says that compared with placebo, its dry eye treatment, diquafosol tetrasodium, did not significantly improve corneal clearing, the trial’s primary endpoint, in its six-week Phase III study. The compound also failed to reach secondary endpoints based on the Ocular Surface Disease Index, but its effect on corneal staining, conjunctival staining and conjunctival clearing was consistent with results of previous late-stage studies, according to Inspire. Patients using diquafosol tetrasodium reported burning or stinging more often than those using the placebo, but Inspire added that the incident rate was less than five percent. Based on these results, the company held a preliminary discussion with the FDA regarding the next step for the drug. Inspire intends to file a New Drug Application amendment for diquafosol tetrasodium by the end of this year’s second quarter.
And now the (potentially) good:
NOVARTIS LICENSES INVESTIGATIONAL DRY EYE TREATMENT. Novartis has in-licensed rebamipide, an investigational treatment for dry eye, from Japan-based Otsuka Pharmaceutical Company, Ltd. Rebamipide is currently being tested in two Phase III studies in the United States and is expected to demonstrate a novel mechanism of action to enhance tear secretion and increase the levels of mucin covering the conjunctiva and cornea. Under the agreement, Novartis will obtain an exclusive license with the right to sub-license the compound globally, excluding Japan and selected Asian countries. Novartis will pay an upfront fee and annual royalties. The terms of the agreement were not disclosed.
Keep those fingers crossed, my friends...
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