• EG-Mirotin is a RGD-motif containing human recombinant polypeptide (compound name: EGT022 / 58 amino acids / MW: 6.1-kDa).
• First in Class novel subcutaneous drug targeted to suppress edema and vascular leakage in abnormal retinal microvasculature through that normalization and stabilization of damaged retinal microvasculature.
• Pre-clinical toxicity studies were successfully completed both in-house and in Europe (Switzerland) with no signs of toxicity and/or genotoxicity. Additional studies confirmed there were no undesirable angiogenesis and effects on tumor growth. Pre-clinical efficacy studies were conducted in both the Oxygen-Induced Retinopathy model and Streptozotocin-induced diabetic rat model. Retinal flat mount and angiography results have demonstrated formation of stabilized and mature retinal vasculature, and Optical Coherence Tomography (OCT) measurements have shown a statistically significant reduction in macular edema.
• Phase I safety studies conducted in Europe (Netherlands) was successful. Treatment with EG-Mirotin in single and multiple doses was well tolerated in all subjects (both healthy and diabetic patients).
• Phase IIa proof-of-concept studies are currently being conducted in Europe (France).
• EGT022 and its potential applications
3. Market Feasibility
Incidence and prevalence of Diabetic Retinopathy (Global)
• Recent studies have shown that there were approximately 220 million people with diabetes globally (either diagnosed or undiagnosed) in 2009; Latest WHO statistics have this figure at 347 million as of 2012
• Current prevalence of DR – both NPDR and PDR – is over 100 million worldwide
• 74.7mn estimated with early stage DR symptoms or NPDR
(Source: Visiongain 2010)
4. Technical Advantages
• Laser Photocoagulation has been widely used to treat eye diseases, but only covers Proliferative Diabetic Retinopathy and Age-related Macular Degeneration. Drugs such as anti-VEGF and steroids are available, but vary in efficacy/side effects, and are usually for late-stage Diabetic Retinopathy.
• First in Class novel subcutaneous therapeutic for Non-proliferative Diabetic Retinopathy that is competitive in terms of both route of administration and cost versus current alternate treatments.
5. Technical Highlighted Summary
• Novel sub-cutaneous therapeutic for Diabetic Retinopathy (Non-proliferative Diabetic Retinopathy / NPDR)
• Targeted to suppress edema and vascular leakage in abnormal capillaries in NPDR patients
EG-Mirotin vs. marketed drugs
Company Name EyeGene Roche Regeneron
Product Name EG-Mirotin Lucentis Eylea
(recombinant polypeptide) Ranibizumab
(monoclonal antibody) Aflibercept
(recombinant fusion protein)
Mechanism Normalization and stabilization of retinal vasculature Anti-VEGF preventing retinal neovascularization VEGF-trap preventing retinal neovascularization
Indication NPDR, DR, DME wAMD, DME, RVO wAMD, DME, RVO
Manufacturing Pichia pastoris E. coli CHO K1
Route of Administration Subcutaneous Injection (non-invasive) Intravitreal Injection (invasive) Intravitreal Injection (invasive)
Dosage 1mg or 2mg wAMD : 0.5mg
DME : 0.3mg wAMD : 2.0mg
DME : 2.0mg
Dosing Regimen 5 daily subcutaneous injections Once a month (every 28 days) Once a month (every 4 weeks)
Side Effects general disorders and administration site conditions, NO systemic side effect reported in Phase 1 safety studies conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure, and intraocular inflammation conjunctival hemorrhage, eye pain, cataract, vitreous detachment, floaters, and ocular hypertension
Treatment Cost Approximately 50% of
marketed products $2,000 per injection $1,850 per injection