Lux Biosciences, based in Jersey City, NJ and focused upon the development of ophthalmic disease, has relied upon an in-licensing strategy from corporate partners and academia for molecules and technologies that have demonstrated proof-of-concept in related non-ophthalmic diseases but where common mechanisms of action and biological pathway overlap may be levered.

PRODUCTS IN DEVELOPMENT

LX211, Luveniq™ (granted Fast Track Designation by FDA in 2007; currently in Phase III) is the oral form of a next-generation calcineurin inhibitor, voclosporin, for sight threatening, non-infectious uveitis. The compound reversibly inhibits immunocompetent lymphocytes, particularly T-lymphocytes, and it also inhibits lymphokine production and release. Luveniq™ (oral voclosporin) was discovered by Isotechnika (TSX: ISA) and exhibits features that may permit convenient and predictable dosing. Of great interest, the therapeutic window of Luveniq™ appears to be wide, allowing for a 15-fold range in exposure between a clinically effective dose and the threshold for side effects – such a profile may position the drug as a valuable option for a variety of autoimmune diseases and solid organ transplant.

LX201 (granted Fast Track Designation by FDA in 2008; currently in Phase III) is a silicone matrix ocular implant for the prevention of rejection in corneal transplantation provides sustained release of cyclosporine A (CsA) locally to the eye over the course of one year. LX201 is implanted episclerally (beneath the connective tissue covering the white of the eye) in a minimally invasive procedure. Local delivery of CsA through LX201 potentially offers significant benefits in the treatment of corneal transplantation due to: 1. increased safety resulting from the absence of systemic toxicity of CsA, in particular of renal toxicity 2. increased efficacy, LX201 may establish sustained therapeutic levels of CsA; and 3. increased patient compliance, as dosing cannot be missed throughout the first year after transplantation.

LX212 is a bioerodible polymer minimally invasive implant containing voclosporin, the product may be developed for severe dry eye.. It is designed to elute the active ingredient slowly and steadily to the surface of the eye.

LX214 (currently in Phase I) is a proprietary topical formulation of voclosporin potentially providing concentrations in target tissues of the eye well above the therapeutic threshold. It has been demonstrated that the drug levels in ocular tissues are sustained for 24 hours, allowing for potential once-daily dosing.

INDICATIONS & MARKETS PURSUED

• Uveitis is an autoimmune disease resulting in chronic inflammation of the eye. Uveitis has been an under-diagnosed and under-recognized medical condition that causes vision impairment, ocular pain, and loss of vision. It is estimated that 10% of new cases of blindness in the United States are caused by this disease where approximately 300,000 people suffer from uveitis in the US and 500,000 worldwide. The only therapeutic class approved by the FDA for treatment of uveitis is corticosteroidsa therapeutic approach where even at low doses are often burdened with multiple side effects.

• Dry Eye Syndrome (DES) is a condition that includes a variety of disorders resulting in loss or breakup of the natural tear film, which maintains the surface of the eye, symptoms associated with DES account for up to 40% of all ophthalmologist visits and affecting some 10M patients in US and EU. Without this tear film, vision is impaired, the ocular surface may be damaged, and patients may suffer severe ocular discomfort. DES can be caused by a variety of conditions including excessive tear evaporation and a reduction of tear production in the lacrimal gland, which is the site of tear production. Though there are a variety of medications that palliate the symptoms of DES, there is no cure.

• Age-Related Macular Degeneration (AMD) is a condition affecting the central area of vision and can lead to blurred vision, visual distortions, the appearance of dark spots in the central vision field, and blindness. It is the leading cause of irreversible blindness in the US. There are two forms of AMD: Atrophic (dry) AMD is characterized by the formation of fatty deposits, termed drusen, in the macula. Atrophic AMD leads to slow, but progressive central vision loss. This form of AMD only affects the central vision; peripheral or side vision is spared generally. Roughly 90% of AMD patients suffer from atrophic AMD. Neovascular (wet) AMD occurs when abnormal blood vessels break through Bruch’s membrane (a layer beneath the retina) of the eye. The blood vessels leak fluid and blood into the space beneath the retina in the macula. This can lead to sudden and severe visual impairment. This form of the disease affects roughly 10% of AMD patients, however, 90% of severe vision loss due to AMD is caused by neovascular AMD. There is no cure for AMD. Novel therapies targeting the formation of blood vessels by way of blocking vascular endothelial growth factor (VEGF) have recently become available and represent a major advance in the treatment of the disease. However, only approximately a third of patients respond to VEGF blockers. Hence, there remains a high medical need for therapeutic approaches that could complement VEGF blockade, by targeting alternative biological aspects of this complex disease.

• Approximately 32,000 corneal transplants are performed each year in the United States and an additional 22,000 in Europe. The prevalence of cornea transplant recipients is estimated to be about 350,000 in the United States and Europe. While the cornea is generally a tissue that is not vascularized, up to a third of all patients are at increased risk of immune-mediated rejection reactions and ultimately, graft loss. In addition, the cumulative rate of graft failures by way of loss of endothelial cells and clouding of the graft is significant despite relatively high survival rates. The leading causes of graft failure following initial transplantation include rejection, endothelial rejection without immunological reaction, and ocular surface disease. In addition to the risk of graft loss, rejection episodes lead to the irreversible loss of cells in the cornea resulting in a loss of corneal clarity and sight for the patient.

FINANCING

Lux got going back in 2006 with a sizeable $36M Series A financing with participation from HBM Partners, Novo Ventures, and SV Life Sciences which was shortly was rounded up by $13M, coming primarily from Prospect Venture Partners for a total close of $49M. And in October of 2009 closed a $50M Series B with participation from earlier investors and the SV Life Sciences publicly traded fund, International Biotechnology Trust.

The Company’s intended use of proceeds of these funds are for preparation of a New Drug Application in the US and Marketing Authorization Application in Europe based on positive pivotal LX211 data in non-infectious uveitis, and for of the commercial launch of Luveniq™, if approved, in the US. Since receiving Fast Track Designation for Luveniq™ in August 2007 Lux will request priority review from the FDA and if granted, the Company may gain US approval for Luveniq™ in 2010.