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The timing is right for Visulex®, as the next wave of Back of the Eye therapies will most likely require drug delivery differentiation, and Aciont is on the forefront of the wave.
We can define three tiers of competition: a). other drug delivery companies trying to solve BOTE drug delivery problems through invasive procedures such as intraocular or transscleral implants and injections; b). biotechnology companies developing new drugs some of which are potent or have highly selective tissue targeting attributes; and c). other non-invasive topical/passive, active/iontophoretic and minimally invasive drug delivery companies.
Many of the leading BOTE 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
Lens damage during some procedures
Increased intraocular pressure
Poor access to the outer retina and choroid
Alternatively, Visulex® offers the following:
Non-invasive, safe drug/device delivery system
Patient friendly administration
Easy to administer by staff
Controlled delivery: ability to titrate/customize dose
Sustained delivery from a non-invasive application
Visulex’s passive sustained release system has demonstrated superior pharmacokinetic profiles over other technologies that deliver water soluble agents passively and actively 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.
Aciont is well positioned to execute a plan that demonstrates Visulex’s safety and efficacy in humans.
The following prerequisite milestones have been completed placing Aciont as a viable investment prospect:
Designed and tested various prototype ocular drug delivery applicator designs.Screened specific formulations and other materials to be used for our lead product design for ocular inflammation disease.
Completed several PK and uveitis studies under established preclinical in vivo models demonstrating superior bioperformance over existing conventional and competing technologies. Several drugs screened and tested under such methodologies.
Completed filing of 18 U.S. patents (5 issued) solidifying our innovative technology platform over other competing passive/topically applied, iontophoresis and minimally invasive, ocular drug delivery technologies:
Scleral or corneal applicator designs for optimal tolerance, ease of use, drug delivery and miniaturization
Payload enhancement: membranes and formulations
Specific drug treatment protocols
Sustained release methods and formulations
Iontophoresis and other poration methods
Our sustained release, electroporation and iontophoretic technology platforms may have potential applications in other therapeutic indications pertaining to transmucosal or transdermal drug delivery treatments.
Our team also comprises excellent advisors in medical ophthalmology, pharmaceutical R&D, engineering/materials, and leaders within the ocular industry.