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Bausch + Lomb Acquires Option to License New Compound to Treat Dry Eye Syndrome (DES)

Bausch + Lomb, the global eye health company, and Mimetogen Pharmaceuticals Inc. today announced that Bausch + Lomb has acquired an option to license an investigational compound currently in Phase 2 development for the treatment of dry eye syndrome (DES), a condition that affects millions of people worldwide. Dry eye occurs when the eye does not produce enough tears, or when the tears produced are not of the correct consistency and evaporate too quickly. The compound, called MIM-D3 and developed by Mimetogen, has the potential to be the first in a new class of agents called TrkA agonists.

"Dry eye is among the most common conditions seen by eye care professionals, and its prevalence is increasing as the population ages,"Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 said Penny A. Asbell, M.D., professor of ophthalmology at Icahn School of Medicine at Mount Sinai and director of the Cornea Service and Refractive Surgery Center. "While effective treatments exist, they often may take months to relieve symptoms, and they may not work for every patient. If proven effective, this compound could offer an exciting new therapeutic option for this increasingly common condition."

DES is a chronic disorder of the ocular surface that affects millions of people around the world (25 million in the U.S. alone).Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 The prevalence of the condition increases 35 percent each decade after age 40,EpiCast Report: Dry Eye Syndrome – Epidemiology Forecast to 2022 (Published MAR 2013) with the largest percentage of cases found in adults aged 60-80.Kantar Health Epi Database, 2011 Other risk factors include gender (women are twice as likely to have DES as men), use of certain medications and diet.American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern – Guidelines. Dry Eye Syndrome-Limited Revision. San Francisco, CA: American Academy of Ophthalmology; 2011.

Currently available dry eye therapies work to increase tear production, but do not address tear quality. MIM-D3 stimulates the production of mucin, which plays a critical role in the protection and overall health of the ocular surface. Mucins are essential for lubrication; the removal of allergens, pathogens, and debris; and corneal epithelial healing to reduce ocular surface damage. In addition, MIM-D3 may have additional benefits than currently available dry eye therapies including the potential to improve neural function, which may improve corneal sensitivity and integrity.Joo MJ et al. The Effect of Nerve Growth Factor on Corneal Sensitivity After Laser in Situ Keratomileusis. Arch Ophthalmology. 2004 Sep; 122(9): 1338-41

Phase 2 study results for MIM-D3 demonstrated that the use of MIM-D3, dosed twice a day, results in consistent improvements across multiple dry eye signs and symptoms with no safety or tolerability issues. A Phase 3 study is scheduled to begin before the end of 2013, which will be conducted by Ora, Inc.

"Bausch + Lomb is committed to delivering effective ophthalmic therapeutic solutions for eye care professionals and their patients, and dry eye represents a significant unmet need," said Cal Roberts, M.D., chief medical officer, Bausch + Lomb. "Given the promising results of the Phase 2 studies, we are excited about the potential of giving eye care professionals a new choice for treating one of the most common and bothersome eye conditions."

If approved, the new technology would dramatically expand Bausch + Lomb's ability to compete in a $2.5 billion global dry eye market growing at 10 percent annually,IMS MIDAS (MAT Q1 2013) while creating an opportunity to explore expanded ophthalmic applications.

"Bausch + Lomb and Mimetogen share a commitment to developing new and effective therapies that address unmet medical needs," said Garth Cumberlidge, Ph.D., president and chief executive officer, Mimetogen Pharmaceuticals. "We are thrilled to be working with such a respected partner as Bausch + Lomb. The company's commitment to innovation, expertise and resources, combined with its global reach and powerful brand, will help ensure that, if approved, this technology will reach its full potential for the millions of people suffering from DES."

Under the terms of the agreement, Bausch + Lomb will pay Mimetogen an upfront payment as an option fee to secure the right to acquire an exclusive global license on set terms triggered by the availability of top line results from a Phase 3 study. Should Bausch + Lomb choose to pursue development based on the Phase 3 results, the company will assume all development responsibilities and costs, and also will pay development milestones, sales milestones and royalty fees to Mimetogen.

About Dry Eye Dry eye occurs when the eye does not produce enough tears, or when the tears are not of the correct consistency and evaporate too quickly. Inflammation of the surface of the eye may also occur. If left untreated, the condition can lead to pain, ulcers, or scars on the cornea, and some loss of vision, although permanent loss of vision from dry eye is uncommon. Dry eye can also have a significant impact on quality of life, making it more difficult to perform activities such as using a computer or reading for an extended period of time.

About Mimetogen PharmaceuticalsMimetogen Pharmaceuticals Inc. is a private company focused on developing the use of peptidomimetics as a novel approach to treating ophthalmic diseases with high unmet medical needs. The underlying technology was developed at McGill University and the Lady Davis Institute for Medical Research in Montreal. The company is currently developing novel therapeutic approaches for indications including dry eye disease, glaucoma and other degenerative diseases of the retina.

About Bausch + LombBausch + Lomb is a leading global eye health company that is solely focused on protecting, enhancing, and restoring people's eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries. Founded in 1853, our company is headquartered in Rochester, NY, and employs more than 11,000 people worldwide.