FDA Green Lights Allergan’s Tear Neurostimulator
Allergan has been granted marketing authorization from the FDA for its TrueTear Intranasal Tear Neurostimulator. This is the only FDA-approved device designed to temporarily increase tear production during neurostimulation in adults with dry eye. TrueTear is a handheld stimulator with daily disposable tips that is inserted into the nasal cavity to induce tear production.
Lucentis Approved for All Forms of DR
The FDA has approved Genentech’s Lucentis (ranibizumab 0.3 mg injection) for the monthly treatment of all forms of diabetic retinopathy. Lucentis becomes the lone agent FDA-approved to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular edema (DME). In February 2015, Lucentis received FDA approval for the treatment of DME based on data from the pivotal RIDE and RISE Phase III clinical trials.
Glaukos Acquires IOP Sensor Implant
Glaukos Corporation acquired the DOSE Medical intraocular pressure (IOP) sensor from DOSE Medical Corporation for $5.5 million in cash plus potential milestone payments of up to $9.5 million. The DOSE Medical IOP sensor system features a micro-invasive ocular implant designed to capture and store a glaucoma patient’s short-interval IOP measurements over extended periods of time, and to transmit that data to the patient’s physician. The wireless system, designed for ab-interno insertion, incorporates a rechargeable battery that may allow the sensor to function for multiple years.
Dr. Guyer Steps Aside as CEO at Ophthotech
Still reeling from disappointing Phase III results of Fovista (pegpleranib) in combination with Lucentis (ranibizumab, Genentech) last year, Ophthotech Corporation announced that co-founder and chairman David R. Guyer, MD, will yield the CEO’s office to current president and CFO Glenn P. Sblendorio effective July 1. At that time, Dr. Guyer will assume the title of executive chairman. Sblendorio will retain the title of president.
Opthea Gets Positive Feedback
Coming off word that the Phase I/IIa clinical trial of its novel anti-VEGF candidate for treatment of age-related macular degeneration (AMD) exceeded expectations, along with positive regulatory feedback and a new round of fundraising, Australia-based Opthea is looking to expand the Phase IIb trial of its lead candidate, OPT-302, in combination with Lucentis and add on two Phase II trials of the agent in DME and wet AMD refractory to anti-VEGF-A therapy.