Clinical Background

The nature of ophthalmic disease and the unique anatomical and physiological features of the eye, combined with the extreme fragility of the eye, dictate that identifying the correct pharmaceutical agent for a specific disease state represents only half the solution. The pharmaceutical agent must be delivered in a manner that maximizes clinical efficacy, while minimizing costs and adverse effects. Historically, treatment of intra-ocular diseases has consisted primarily of the use of topical eye drops, used for lack of superior treatment alternatives. Numerous issues result from the use of topical eye drops including:

·   Lack of effectiveness – The eye is anatomically and physiologically designed to isolate and protect its contents.  These inherent mechanisms make it very difficult to introduce drugs into the eye through topical administration.  Topical administration for many critical drugs is not possible.  For other agents, the intraocular levels achieved are very erratic, with the majority of the drug never reaching the intended intra-ocular location.  This also applies to topical administration using subconjunctival injections.

·   Negative impact on safety – While a relatively small amount of the topically administered drug actually reaches the interior of the eyes, the majority of the drug is systemically absorbed.  This results in unnecessary and clinically significant side effects.

·   Poor Compliance – Patients do not like to self-administer eye drops, negatively impacting efficacy.  Difficult self-administration, especially in the elderly, results in much of the dose being wasted, further reducing efficacy.

The use of intravitreal injections is seen with increasing frequency in the treatment of many ophthalmic diseases.  Unfortunately, targeted conditions are chronic in nature and the duration of the effect of the intravitreal injection is limited.  Ranibizumab (Lucentis®) must be intravitreally injected about every four weeks for the treatment of wet age-related macular degeneration (AMD).  The associated cost, risk of infection, pain and other side effects make frequent intravitreal injections far from ideal.

Icon Bioscience’s Verisome® technology will revolutionize the treatment of eye disease.  Whether obviating the need for antiquated eye drops, allowing intravitreal injections to be effectively administered or permitting the use of new drugs, significant opportunities exist in every major market for products internally developed by IBI or in partnership.  Products administered using the Verisome® technology will ultimately represent the standard of care in every major ophthalmic market.