Sustained-Release Eylea Focus of Collaboration
Ocular Therapeutix Inc. and Regeneron entered into a collaboration agreement to develop a sustained-release formulation of Regeneron’s Eylea (aflibercept), currently in preclinical development. Ocular Therapeutix is developing proprietary sustained-release hydrogel-based drug delivery depots for intravitreal injection that can be formulated with both small- and large-molecule agents. Ocular Therapeutix would receive a $10 million up-front payment and take responsibility for funding development through Phase I. Milestone payments to Ocular Therapeutix could total up to $305 million.
Second Sight Performs First Wireless Implant
Second Sight Medical Products Inc., developer of the Argus II retinal prosthesis system, announced the first successful implantation and activation of a wireless visual cortical stimulator in a human, providing the initial human proof of concept for the ongoing development of the Orion Visual Cortical Prosthesis. A 30-year-old patient was implanted with a wireless multichannel neurostimulation system on the visual cortex and was able to perceive and localize individual phosphenes or spots of light with no significant adverse side effects. The study was performed at UCLA.
Alcon Launches CyPass Micro-Stent
Alcon used the American Academy of Ophthalmology annual meeting to launch the CyPass Micro-Stent, its device for microinvasive glaucoma surgery (MIGS) that the FDA approved in July. Alcon hosted a live training program and announced that new data presented at the AAO, in the form of two posters and a paper, showed the CyPass achieved lower intraocular pressures over two and three years.
AGTC Files IND for Second Achromatopsia Therapy
Applied Genetic Technologies Corporation (AGTC) has filed an investigational new drug application with the FDA to conduct a Phase I/II clinical trial of its second gene therapy candidate for the treatment of achromatopsia – this one for mutations in the CNGA3 gene. AGTC already has a Phase I/II clinical trial underway of its gene therapy candidate for achromatopsia caused by mutations in the CNGB3 gene. The company plans to initiate the trial of the CNGA3 therapy in the coming months.
Allergan Secures FDA Nod for New Restasis
Allergan received FDA approval for Restasis Multidose (cyclosporine 0.05%), a preservative-free, multi-dose bottle of the dry eye agent that had been available only in single-use vials since its launch in 2003. The multi-dose bottle is designed with a patented unidirectional valve and air filter technology that eliminates the need for a preservative. It will be available for the same price as Restasis single-use vial, Allergan said.