dexamethasone ophthalmic (EGP-437) / Kiora Pharma - LARVOL DELTA

A wearable iontophoresis enables dual-responsive transdermal delivery for atopic dermatitis treatment. (PubMed, J Colloid Interface Sci) - "Evaluation in hairless mouse skin demonstrates the efficacy of this technology by facilitating transdermal transport of 12.2 μg cm-2 dexamethasone phosphate when discharged with a 103 Ω external resistor for 3 h. The Zn battery-driven iontophoresis results in an effective treatment of atopic dermatitis, displaying reductions in epidermal thickness, mast cell infiltration inhibition, and a decrease in IgE levels. This work provides a new treatment modality for chronic epidermal diseases that require precise drug delivery in a non-invasive way."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Controlled simultaneous iontophoresis of buflomedil hydrochloride and dexamethasone sodium phosphate to the mucosa for oral submucous fibrosis. (PubMed, Int J Pharm) - "Co-iontophoresis enabled the controlled simultaneous delivery of BUF and DEX-P achieving therapeutically relevant concentrations after current application for only 5 minutes. Short duration topical co-iontophoresis of multiple therapeutics to the mucosa increases local bioavailability and presents a patient-friendly treatment for oral submucous fibrosis."

Journal • Fibrosis • Immunology

EyeGate announces encouraging interim data from phase 1b/2a clinical trial of EGP-437 for treatment of ocular inflammation and pain post cataract surgery (EyeGate Pharma Press Release) - P1b/2a; N=50; "A positive response was observed in the majority of the patients, with some patients in 9.0 and 14.0 mA-min cohorts presenting with ACC of zero at day 14 and others presenting with trace ACC levels...A double-masked, prospective randomized, controlled trial is expected to initiate by the end of 2016."

Anticipated new trial • P1/2 data • Ocular Inflammation

Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery (clinicaltrials.gov) - P2b; N=100; Recruiting; Sponsor: Eyegate Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • CNS Disorders • Immunology • Ophthalmology • Pain

EyeGate Pharma receives USPTO notice of allowance for proprietary dexamethasone phosphate formulation (GlobeNewswire) - "Eyegate Pharmaceuticals...today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent application related to its lead product candidate, EGP-437. The patent covers a method of treating eye conditions using EyeGate's proprietary Dexamethasone Phosphate pharmaceutical formulation delivered by ocular iontophoresis."

Patent • Ocular Inflammation

EyeGate signs licensing agreement with Valeant Pharmaceuticals for EGP-437 combination product in uveitis (GlobeNewswire) - "...EyeGate has granted Valeant exclusive, worldwide commercial and manufacturing rights to its EyeGate® II Delivery System and EGP-437 combination product ("Product") in the field of uveitis, as well as a right of last negotiation to license the Product for other indications."

Licensing / partnership • Ocular Inflammation

Chardan initiates Eyegate Pharma at buy, sets $6 target (Benzinga) - "Eyegate Pharma is currently preparing for EGP-437 to enter a larger Phase 3 confirmatory clinical study, which could commence shortly...the next key catalyst for Eyegate Pharma’s shares would be the results from the company's Phase 1b/2a clinical trial...The company is expected to report top-line data from this study in 1Q16."

Anticipated new P3 trial • Anticipated P1/2 data • Ocular Inflammation

EyeGate Pharma acquires Jade Therapeutics (EyeGate Pharma Press Release) - "Eyegate Pharmaceuticals...today announced that it has acquired Jade Therapeutics...a privately-held company developing locally administered, polymer-based products designed to treat poorly-served ophthalmic indications."

M&A • Ocular Inflammation

Iontophoretic Dexamethasone Phosphate Compared to Topical Prednisolone Acetate 1% for Noninfectious Anterior Segment Uveitis. (PubMed, Am J Ophthalmol) - "Despite clinically similar response rates, statistical noninferiority of EGP-437 versus a tapered regimen of PA 1% was not achieved. Numerical trends suggesting fewer IOP elevations with EGP-437, similar efficacy overall, and possibly better efficacy in more severe disease warrant further study."

Journal • Complement-mediated Rare Disorders • Immunology • Ocular Inflammation • Ophthalmology • Rare Diseases • Uveitis

Ophthalmic Drug Delivery Using Iontophoresis: Recent Clinical Applications. (PubMed, J Ocul Pharmacol Ther) - "The EyeGate II delivery system (EGDS) is a trans-scleral iontophoresis system that has been used in conjunction with EGP-437, a proprietary-charged formulation of dexamethasone phosphate for iontophoretic delivery. In patients with noninfectious anterior uveitis, EGP-437, delivered through 2 iontophoretic treatments using the EGDS, demonstrated similar efficacy to topical prednisolone acetate 1% eye drops instilled 8 times daily over 28 days, suggesting the potential to decrease or eliminate the need for daily dosing of topical steroids in this patient population...The reviewed studies demonstrate the feasibility of using iontophoresis to enhance drug delivery to ocular tissues and support the potential of this noninvasive technique across a range of ophthalmic indications."

Clinical • Journal