Overview

At Alimera Sciences we are engaged in both developing unique pharmaceuticals for ophthalmic diseases and making products commercially available to eye care professionals and patients. Since our inception, we have executed a two-fold approach. In the first years, we focused commercially on delivering unique and differentiated ethical over-the-counter ("OTC") products to patients and eye care providers. As the company matured, we shifted focus to diseases affecting the back of the eye, or retina, because we believe these diseases are not well treated with current therapies.

In 2004, Alimera Sciences introduced Soothe® Emollient (Lubricant) Eye Drops to people who suffer from the pain and inconvenience of dry eyes. Soothe was the first multi-dose lubricant eye drop to feature Restoryl®, a unique lipid restorative that works to re-establish the lipid (oily) layer of tears, promoting sustained moisture retention.  Soothe was sold to Bausch and Lomb in August of 2007. In 2006, Alimera Sciences developed and submitted for FDA approval, an application for an Rx to OTC switch of 0.025% ketotifen fumarate, for the temporary relief of ocular itch. This product, Alaway™, was approved by the FDA in December of 2006 and was then sold along with a potential future line extension to Bausch & Lomb, who began marketing Alaway in the spring of 2007.

Alimera Sciences main focus is on Iluvien, which we are developing for the treatment of diabetic macular edema, or DME.  DME is a disease of the retina which affects individuals with diabetes and can lead to severe vision loss and blindness.  Iluvien consists of a tiny cylindrical polyimide tube that contains 180 µg of fluocinolone acetonide (FA), a known corticosteroid with a history of treating ocular diseases.  Iluvien is administered as an intravitreal insert and its design provides for a sustained-release that delivers a low daily dose of FA over an anticipated 24 to 36 month period.  Iluvien is inserted into the patient’s eye in the retinal specialist’s office using a procedure very similar to intravitreal injection, a procedure commonly employed by retina specialists.  

Currently, the standard of care for treating DME involves laser photocoagulation therapy, which can leave irreversible blind spots. Many other systemic compounds will not produce a therapeutic effect in the back of the eye and those currently under clinical investigation must be injected often due to a lack of long term release characteristics.

Pipeline

Iluvien is being studied in a clinical trial with retinal specialists to determine its safety and efficacy for the treatment of wet age related macular degeneration (AMD) and we plan to initiate additional clinical trials for other diseases of the eye. In addition to these other activities related to the development and commercialization of Iluvien, we have acquired options to exclusive, worldwide licenses of patent applications covering two classes of NADPH (Nicotinamide Adenine Dinucleotide Phosphate) oxidase inhibitors from Emory University. Our initial focus is on the use of NADPH oxidase inhibitors to treat dry AMD. We plan to conduct additional testing on the use of NADPH oxidase inhibitors to treat other diseases of the eye, including wet AMD and diabetic retinopathy. We are also pursuing the development, license or acquisition of rights to potential new drugs and delivery mechanisms to address diseases of the eye that are not well managed by current therapies.