Technology Description

One revolutionary aspect of our technology platform is the incorporation of a novel sustained release methodology for water soluble or poorly soluble drugs (commonly susceptible to ocular clearance effects) as part of a non-invasive or topical drug delivery system. Visulex’s passive sustained release system has demonstrated superior pharmacokinetic profiles over other technologies that deliver water soluble and poorly soluble agents passively and actively (iontophoresis) to the posterior pole of the eye and has been shown to treat retinal disease under a known preclinical model using a variety of proprietary pharmaceutical formulations and methods. Many of the leading back of the eye drug delivery technologies are invasive in nature because they target the eye’s interior regions such as the vitreous or retina, which often cannot be reached via conventional methods (e.g., eye drops). Risks of various side effects observed during or following intraocular invasive procedures include the following: conjunctival and vitreous hemorrhage; ocular trauma; lens damage during some procedures; eye pain; vitreous floaters; increased intraocular pressure; cataracts; intraocular inflammation; endophthalmitis; retinal detachment; and poor access to the outer retina and choroid.

Proprietary Description

Aciont has completed filing of 18 U.S. patents (4 issued) solidifying our innovative technology platform over other competing topically applied (passive or active) and minimally invasive, ocular drug delivery technologies. Patents cover a wide range of ocular applicator device designs, pharmaceutical formulations, drug treatment protocols, eye tissue poration techniques and sustained release methods.

Market Description

The back of the eye and retina treatment market is driven by an aging population. The next wave of retina disease therapies are expected to require product differentiation attributes via drug delivery improvements: uveitis/ocular inflammation ($500M global market); macular edema ($1.5B); age-related macular degeneration ($5.0B); and diabetic retinopathy ($1.5B). In the United States, roughly 2,000 retinal specialists comprise a viable marketing channel for administering to patients our Visulex-based products. However, physician assistants potentially may administer Visulex's non-invasive treatments, whereas intraocular injections, for example, must be administered by a physician. Also, at home, self administration therapy maybe possible. On average, drug treatments for back of the eye, sight threatening diseases typically reimburse around "$10,000 per eye, annually." Notable recent therapies approved yield substantial product margins which includes Retisert® ($19,000 per device implant) and Lucentis® ($2,000 per injection). If we estimate $4,000 in sales per patient annually and 5,000 initial patients, the first product treating uveitis could generate sales of $20 million in the first year. Peak sales on the first product could reach $200 million within five years (assuming reaching 50,000 patients).