After Trial Fails, Acucela Goes It Alone with Emixustat
Otsuka Pharmaceutical Group terminated its agreement with Acucela to develop emixustat after the Phase IIB/III trial of the drug failed to reach its primary endpoints. The trial involved the use of emixustat for geographic atrophy secondary to dry age-related macular degeneration (AMD). Meanwhile, Acucela said it is continuing with a Phase II trial of emixustat in proliferative diabetic retinopathy and is sticking with its plan to start a clinical trial of the drug in Stargardt disease by the end of the year.
Ophthotech Completes Recruitment, Gets Milestone Payout
Ophthotech Corp. completed patient recruitment of its Phase III trial of Fovista (pegpleranib), anti-PDGF therapy for wet AMD, and triggered a $30 million payment from Novartis. The trial is for Fovista in combination with Eylea (aflibercept, Regeneron) or Avastin (bevacizumab, Genentech) for the treatment of wet AMD. Last year, Ophthotech completed enrollment in two other Phase III trials of Fovista in combination with Lucentis (ranibizumab, Genentech). The FDA granted Fovista fast-track status for treatment of wet AMD in September 2013.
Phase I Results Positive for Apellis’ C3 Inhibitor
Apellis Pharmaceuticals announced positive results from two Phase I clinical trials of its complement C3 inhibitor, APL-2, for the treatment of geographic atrophy. In all, 40 subjects received subcutaneous APL-2 either as a single dose (45–1,440 mg) or repeated doses for 28 consecutive days (30–270 mg/day). Both studies concluded that pharmacological doses of APL-2 were safe and well-tolerated, and daily doses of 180 mg and 270 mg significantly reduced red blood cell destruction as early as eight days after the start of dosing and continuing throughout the dosing period.
Ocular Therapeutix’s Anti-Allergy Trial Falls Short
A second Phase III trial of the safety and efficacy of the ocular allergy treatment Dextenza failed to reach its primary endpoint, sending Ocular Therapeutix’s stock price plummeting more than 50%. Dextenza is a sustained-release dexamethasone platform that a physician administers via a bioresorbable intracanalicular depot. The vehicle is designed to release the drug for up to 30 days.
ReVision’s Raindrop Inlay Secures FDA Approval
ReVision Optics reported the FDA approved its Raindrop Near Vision Inlay, a novel corneal inlay for the surgical correction of presbyopia. The results submitted to the FDA in the company’s PMA application showed clinically significant improvement in near visual performance including 98% of patients achieved uncorrected near visual acuity (UCNVA) of 20/40 or better and 88% of patients achieved UCNVA of 20/25 or better at 24 months in the treated eye. John Kilcoyne, ReVision Optics President and Chief Executive Officer, reported the company would begin US commercialization of Raindrop in the third quarter.