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Medicare To Cover Intraocular Telescope

Effective October 1, 2011, outpatient facilities can obtain reimbursement for the intraocular telescopic implant for covered procedures. Medicare has granted transitional pass-through payment status and established a billing code for the device. FDA has approved it for patients with end-stage age-related macular degeneration, central vision blindness, failure to respond to AMD medications, or in patients that have a form of the disease for which no treatment is available.

 

FDA Approves Stem Cell Trial in Eyes

A private company has just received FDA approval for a Phase 1/11 trial (second trial) involving implanting embryonic stem cells into the eye to replace damaged retinal pigment epithelium cells.  The 12 patients in the trial suffer from Stargardt’s macular dystrophy, a childhood version of macular degeneration.  The technique does not require destruction of the embryo.  “What this approval shows is that the readiness of the FDA to work with researchers to move exciting new stem cell based therapies out of the lab and into the clinic.”

Priority Review of NEW AMD Drug

The FDA has granted a priority review for VEGF Trap-Eye, a new drug designed to stop the growth of abnormal vessels in the eye. Trap-Eye is a fusion protein that blocks the growth factors leading to neovascularization in macular degeneration. The priority review sets the decision date at August 20, 2011. Bayer and Regeneron are collaborating on the Trap-Eye treatment for wet AMD. Regeneron has exclusive rights to VEGF Trap-Eye in the US, while Bayer intends to market it outside the US.