Outlook Therapeutics (NASDAQ:OTLK) completed patient enrollment in its pivotal clinical trial evaluating LYTENAVA, an ophthalmic formulation of bevacizumab, for use in retinal indications.
Formerly known as ONS-5010, LYTENAVA is a humanized anti-VEGF antibody designed to inhibit angiogenesis.
The company enrolled 227 patients who will be treated with either monthly intravitreal injections of LYTENAVA for 12 months or LUCENTIS, dosed quarterly.
The trial’s primary endpoint is the difference in proportion of LYTENAVA patients who gain at least 15 letters in the best corrected visual acuity at 11 months, compared with patients receiving LUCENTIS.
“Given the high cost of the present FDA-approved anti-VEGF therapies, many physicians have turned to off-label repackaged bevacizumab supplied by compounding pharmacists,” Dr. Mark Humayun, Outlook’s medical advisor, said in a statement.
“There is significant unmet patient need for an FDA-approved bevacizumab for use in treating retinal diseases. I believe that LYTENAVA, if approved, will offer clinicians an important new, safe and effective, on-label anti-VEGF therapy option across the spectrum of retinal care,” he added.
Outlook expects to report pivotal safety and efficacy data from the trial in the third quarter of 2020.
