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FDA grants MacuSight fast track designation for DME drug

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UNION CITY, Calif. — MacuSight received fast track designation from the U.S. Food and Drug Administration for Perceiva, its proprietary drug for the treatment of diabetic macular edema, the company announced in a press release.

Perceiva is an ocular formulation of sirolimus, an mTOR inhibitor designed for minimally invasive, sustained and local delivery. The drug is believed to inhibit inflammation, angiogenesis, vascular permeability, proliferation and fibrosis, the release said.

MacuSight is conducting four phase 2 clinical trials of Perceiva for various indications.

With fast track designation for Perceiva, MacuSight will have the opportunity to submit portions of a New Drug Application (NDA) for the drug as they are completed, rather than having to file a completed NDA. The process may expedite the FDA's review and approval of the application, the release said.

MacuSight has enrolled 131 patients in the DIAMOND trial, a phase 2 study of Perceiva for DME. The randomized, placebo-controlled study will comprise four treatment arms: three dosage levels and placebo delivered via minimally invasive subconjunctival injection.

The company is also conducting three phase 2 trials of Perceiva for wet age-related macular degeneration and dry eye syndrome.

MacuSight plans to release early data from all four trials in the first half of 2010, the release said.

Two phase 1 clinical trials of Perceiva that included 80 patients with DME and wet AMD showed Perceiva to be safe and well-tolerated when delivered through minimally invasive subconjunctival injection and intravitreal injection.