Healthcare Industry News:  fast track designation 

Biopharmaceuticals Ophthalmology

 News Release - April 11, 2012

MacuCLEAR, Inc. To Begin Phase III Study of its Lead Compound for Early-Stage Age-Related Macular Degeneration (AMD)

Receives Positive Feedback from End-of-Phase II Meeting With FDA

PLANO, Texas, April 11, 2012 -- (Healthcare Sales & Marketing Network) -- MacuCLEAR, Inc., a clinical stage specialty pharmaceutical company focused on discovering and developing novel solutions for vascular disorders of the eye, announced today it is beginning Phase III studies for its lead compound, MC-1101, for early-stage (Dry) age-related macular degeneration (AMD), based on positive feedback during the company's end-of-Phase II meeting with the FDA.

MC-1101 is a proprietary, topically administered eye drop drug for treating and stopping the progression of AMD from the early-stage (Dry AMD) to the late-stage (Wet AMD) by increasing ocular blood flow in the choroidal vessels.

The first stage of MacuCLEAR's double-blinded Phase III study will examine 60 patients, using improvements in visual function as the trial's primary endpoint.

"We're encouraged by the data generated for MC-1101 and are confident we'll meet the FDA's requirements set forth during our end-of-Phase II meeting," said MacuCLEAR president and CEO, Philip G. Ralston. "We undoubtedly believe we're at the forefront of providing patients with AMD a means of preventing this terrible disease from advancing to its later stages."

In addition to the data from this Phase III trial, MacuCLEAR will submit results from non-clinical studies to the FDA before filing for a new drug application (NDA).

To date, MacuCLEAR has completed a successful Phase Ib/proof of concept human clinical trial for MC-1101 which showed that this drug is not only safe and well tolerated by study subjects, but MC-1101 eye drops also migrate to the back of the eye through proven pathways and provide unique and effective treatment for AMD at the source of the problem by increasing blood flow in the back of the retina.

MacuCLEAR's technology has been developed based on the findings of George Chiou, Ph.D., chief scientific officer of MacuCLEAR, who spearheaded the investigations that led to the development of MC-1101 for ophthalmic use. Dr. Chiou hypothesized that the pathogenesis of AMD begins with a reduction in choroidal blood flow. This vascular insufficiency is now known as "The Chiou Syndrome."

About MacuCLEAR, Inc.

MacuCLEAR, Inc. is a clinical-stage specialty pharmaceutical company focused on developing innovative treatments for vascular and retinal diseases of the eye. Its lead compound MC-1101 is a novel, topically delivered eye drop drug for treating and stopping the progression of age-related macular degeneration (AMD) from the early-stage (Dry AMD) to the late-stage (Wet AMD) by improving ocular blood flow.

The active ingredient of MC-1101 has been previously approved by the FDA as an oral antihypertensive drug. MC-1101 has been granted 505 (b) 2 status and has formal fast track designation by the FDA. In addition to MC-1101, MacuCLEAR's portfolio includes 11 compounds that are being developed for diabetic retinopathy, second-generation treatment for AMD and other vascular diseases of the eye.

George C.Y. Chiou, Ph.D., who led the development of Timolol, a pioneering treatment for glaucoma, invented this technology at Texas A&M University.

Founded in 2006, MacuCLEAR is a privately held Plano, TX-based company. For additional information, please visit

About Age-Related Macular Degeneration

AMD is the leading cause for blindness in the world in people 50 and older. Dry AMD afflicts 90 percent of AMD sufferers and currently has no approved drug treatments.

Source: MacuCLEAR

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