iVIEW-1201 Phase II IND application for the Treatment of Adenoviral Conjunctivitis Accepted by US FDA

Doylestown, Pennsylvania–iVIEW Therapeutics Inc., an innovative specialty pharmaceutical company committed to becoming a leader in topical drug development with specialization focus on ophthalmology, dermatology and otolaryngology, today announced that its Phase II clinical trial IND application of iVIEW-1201 was been accepted by US FDA. As Dr. Wendy Streight, FDA Regulatory Project Manager, said in her email, “just to confirm, yes, your study is safe to proceed.”

In the pre-IND meeting response from FDA, FDA responded “A phase I safety/tolerability study is not needed for this drug product. There is adequate safety data available to proceed with dose ranging/efficacy studies.” Also FDA stated that “A drug vs. placebo pivotal trial for acute viral conjunctivitis is acceptable.”

Dr. Bo Liang, Chairman & President at iVIEW comments, “I am glad that FDA has accepted iVIEW’s phase II clinical trial IND application of iVIEW-1201 for the treatment of adenoviral conjunctivitis. We will move ahead with our intended global phase II trials in 2019 and we believe iVIEW-1201 being the first sustain release broad spectrum antiseptic formulation will bring significant value to patients as there is no FDA approved treatment for viral conjunctivitis now .”

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