Amorphex Therapeutics is a clinical stage company developing patented technology to address the problems associated with topical ophthalmic drug delivery, a $5+billion dollar market that includes the primary treatment of glaucoma. Topical ophthalmic pharmaceuticals are typically self-administered vi…
Amorphex Therapeutics is a clinical stage company developing patented technology to address the problems associated with topical ophthalmic drug delivery, a $5+billion dollar market that includes the primary treatment of glaucoma. Topical ophthalmic pharmaceuticals are typically self-administered via eye drops but inaccurate dosing, poor compliance and excessive side effects undermine their therapeutic benefits and true sales potential. Amorphex is developing TODDD™, a soft, non-invasive device that is completely concealed under the eyelid that continuously delivers therapeutic levels of drug 24/7 over several months. In recognition of the potential benefits and their developmental progress, the company’s founders have been awarded three National Institutes of Health grants for the TODDD™ technology totaling $2.5 million.
Inserted much like a contact lens, TODDD™ provides attractive levels of comfort, and physiologic tear exchange, ensuring exceptional ocular retention and stability. While TODDD™ is soft and flexible, unlike soft contact lenses, it doesn’t rest on the sensitive cornea or contain appreciable water and thus avoids the surface drying and resulting deposits that irritate and deter many contact lens wearers. Additionally, Amorphex has demonstrated in two animal studies that, unlike eye drops, no detectable amount of drug delivered using a TODDD™ device is distributed systemically.
The TODDD™ device possesses many other advantages over competitive product concepts. For example, Amorphex has also developed a TODDD™ prototype which incorporates drug depots within a matrix body so that one TODDD can deliver multiple drugs in fixed dose combinations (FDC). Given that greater than 40% of the US glaucoma patients are prescribed more than one glaucoma drug, this has clear therapeutic applicability.
Major Development Progress to Date: • Demonstrated controlled drug release from TODDD™ material in vitro 180+ days • Completed animal safety studies of TODDD™ materials • Designed and produced human prototype devices (Demonstrating success without drug in recent clinical trials) • Demonstrated glaucoma therapeutic efficacy by reducing intraocular pressure (IOP) in a 90-day rabbit study • Reduced IOP more than 35% in a normotensive beagle study • Developed a cast molding manufacturing process that promises low device cost • Patents issued in US, Europe and Japan • Held a pre-IND meeting and discussions with FDA • A single TODDD most recently demonstrated 6 months of uninterrupted drug delivery and therapeutic response in a human experimental trial. A distinct clinical benefit and a record for a non-invasive device.
Experienced Team – Founded company in 2010 • Robert Thompson – CEO, former President of 2 Bausch & Lomb divisions
• Edward Ellis, Ph.D. – VP Science & Technology, with 30+ patents supporting $2+ billion in sales
• Charles Leahy, O.D. , M.S. - VP Clinical Affairs, practicing clinician (2 days per week) - Massachusetts Eye & Ear Infirmary (Harvard Medical School) Has extensive developmental pharmaceutical clinical testing experience
Amorphex currently has laboratory and office facilities in Andover, Massachusetts and additional laboratory facilities at the Massachusetts Medical Device Development Center, (M2D2).
Investment Opportunity: Amorphex is seeking up to $6.0 million to fund human clinical trials of TODDD™ delivering timolol, prostaglandin and both drugs simultaneously. This funding will also support pre-clinical development of TODDD™ for ocular allergy and inflammation applications. These milestones will drive dramatic increases in valuation and corporate partner interest.
Team (1)
Sectors Amorphex Therapeutics serves:
Life Sciences
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