Eye on Five – August Edition
Shire Makes Xiidra Available in US
With FDA approval of Xiidra (liftegrast) in hand, its dry eye challenger to Allergan’s Restasis (cyclosporine), the next step for Shire was to make Xiidra commercially available in the US. Shire announced that it took that step on August 29. In a post titled “The Shire vs. Allergan War Has Begun,” Seeking Alpha blogger Daniel Katz said, “With a much stronger efficacy and similar pricing structure, expect Xiidra to nab a hefty chunk of market share, and quickly.”
Pfenex Lucentis Biosimilar Completes Phase I/II Trial
Pfenex took a couple of steps forward in developing PF582, its Lucentis (ranibizumab) biosimilar candidate: it regained full control of its rights to PF582 from former partner Pfizer, and it announced Phase I/II results showed PF582 is comparable to Lucentis in meeting safety and tolerability endpoints. Trials presented at the American Society of Retina Specialists also reported positive results for Lucentis biosimilar candidates.
Roche License Eleven’s DME, Uveitis Candidate
Eleven Biotherapeutics has entered into a licensing agreement giving Roche development and commercialization rights to EBI-031, its interleukin-6 (IL-6) antagonist for which Eleven filed an Investigational New Drug (IND) application with the FDA in June. EBI-031 is for treatment of diabetic macular edema and uveitis. Roche will pay Eleven $7.5 million up front, and $22.5 million when the IND becomes effective. Potential milestones could bring the total value of the agreement to $270 million.
Ocular Therapeutix Makes Progress on FDA Concerns
In early August, Ocular Therapeutix Inc. found that a week could make a big difference in its NDA for Dextenza. One week after putting out a Complete Response Letter (CRL) that identified problems with the company’s manufacturing process for Dextenza, the FDA issued a second letter noting that nine of 10 inspection issues had been corrected. With Ocular Therapeutix continuing discussions with the agency on its manufacturing process for Dextenza, the company’s stock is up more than 50% since the second letter.
Alcon Sings on to Develop TrueVision 3D Microscope
TrueVision’s 3D Digital Microscope Platform, called NGenuity, got a boost just before OIS@ASRS 2016 when the company penned a partnership agreement with Alcon to develop the microscope. This surgical microscope uses digital imaging to eliminate the glare and viewing problems found with traditional optical microscopes, along with an ergonomic “head-up” design that doesn’t require the user to bend over to view the optics. The current iteration is in its fifth generation.