Novartis Ophthalmics, the eye health unit of Novartis, and Valley Forge Pharmaceuticals, Inc., have entered into a licensing agreement for a novel eye medication for the treatment of myopia (nearsightedness).

The compound Pirenzepine is currently in Phase II clinical trials. Upon successful completion of Phase III clinical trials and regulatory approvals, Novartis Ophthalmics will market the compound worldwide.

In Phase II clinical trials Pirenzepine has been shown to reduce the progression of the disease by at least 50 per cent in the first 12 months of therapy in children who suffer from myopia.

Myopia (nearsightedness) is a very common eye disorder, with onset occurring mainly during childhood. It affects approximately 50 million young people (age 5 – 19 years) in industrialized countries. Severe myopia (myopia higher than 6 diopter) and pathologic myopia (myopia higher than 12 diopter) are associated with an elevated risk of ocular complications later in life. Additionally, lesser degrees of myopia may also represent a risk factor for future ocular disorders.

"This novel compound significantly strengthens our development pipeline by addressing myopia, one of the most important unmet needs in ophthalmics," said Dr. Flemming Ørnskov, Head of Novartis Ophthalmics. "It could set new standards for the treatment of this eye disorder, since there is no pharmacological therapy available today."

Paul A. Lopez, CEO of Valley Forge, commented, "We are very excited about this agreement and securing such a strong partner as Novartis Ophthalmics. The licensing of our lead product, Pirenzepine ophthalmic gel, is an important milestone for Valley Forge Pharmaceuticals, Inc. We look forward to a productive collaboration."

Pirenzepine ophthalmic gel is a completely new therapeutic approach to myopia – a relatively selective muscarinic M1 receptor antagonist administered as an eye gel twice a day, which is expected to reduce the progression of myopia (near-sightedness) by up to 50 per cent.