According to a story from prnewswire.com, the biopharmaceutical company Neurotech Pharmaceuticals recently announced that the company had earned Fast Track designation from the US Food and Drug Administration (FDA). This designation was granted in regards to the company’s investigational product candidate Renexus as a treatment for macular telangiectasia type 2. Neurotech is committed to the development of innovative therapies for chronic, long term eye diseases.
About Macular Telangiectasia
Macular telangiectasia, sometimes referred to as MacTel, comprise two different diseases that affect macula, an area of the eye located near the center of the retina. macular telangiectasia type 1 is very rare, tends to affect males, and usually only affects one eye. Type 2 is more common, affects both eyes, and shows no disparity between sexes. The exact cause of the disease is not entirely clear, but type 2 can be passed down in families; the precise genetic abnormality responsible has not been identified. Symptoms and signs of macular telangiectasia include progressive loss of central vision, retinal crystalline deposits, decline in retinal transparency, and dilated capillaries. Vision can be lost in a period of 10 to 20 years. Most patients are first diagnosed during their middle age years. Treatment options for macular telangiectasia are limited; for type 2, there is no known treatment that can halt or slow progression. To learn more about macular telangiectasia, click here.
About Fast Track Designation
Fast Track designation is intended to speed up the development of an experimental drug that is intended to treat a serious, life-threatening disease or fulfill an unmet medical need. It must be requested by the developer. Earning this designation confers several benefits to the recipient company, such as more frequent meetings and collaboration between the developer and the FDA, eligibility for rolling review for the company’s Biologic License Application (which allows the company to submit portions of the application as they are completed), and potential eligibility for Accelerated Approval and Priority Review if other requirements are satisfied.
Renexus comprises an innovative encapsulated cell therapy drug delivery system. The device, once implanted, delivers ciliary neurotrophic factor into the eye, which should reduce the rate of photoreceptor loss and slow the progression of macular telangiectasia type 2.
