Ophthalmology Pipeline Represents a Paradigm Shift in Treatment
THE NEED
- Over 10M injections per year = Heavy treatment burden on patients and doctors
- Approved and pipeline drugs focus on duration of effect after intravitreal injection but still require a retinal ophthalmologist, a care giver to drive to/from visits, and an expensive treatment
OUR SOLUTION
- Patient administers drug at home with autoinjector up to once per month (potential for oral administration)
- Market expansion: > $1B product
- Patients in rural areas receive convenient treatment (especially parts of China and India)
- Diabetic patients maintain compliance (treated for decades)
- Treatment of earlier stage of AMD
- Lower cost – manufactured at up to 1/10 the cost of other approaches
HD Targets Ocular Neovascularization After Systemic Dose
- After systemic dose, uptake ONLY in inflammatory reactive cells
- Crosses blood retinal barrier in monkeys, mice & rats
D-4517: First-in-Class Home Administered Wet AMD Therapy
Mouse Laser CNV Model: Single Subcutaneous or Oral D-4517 Dose on Day 1
Once Every 2+ Weeks or Oral
- D-4517 at 2 mg/kg (40 µg) subcutaneous (SC) dose equivalent to Eylea (aflibercept) intravitreal (IVT) dose (40 µg) at Day 14
- Oral D-4517 doses equally or more effective = >80x therapeutic window, minimal systemic exposure
- HD uptake retinal neovascular genetic model (vldlr) with Campochiaro lab (JHU)
Our Approach
- Patient administers drug at home with autoinjector up to once per month
(potential for oral administration)
Market Expansion
- Patients in rural areas receive convenient treatment (especially parts of China and India)
- Diabetic patients maintain compliance (treated for decades)
- Treatment of earlier stage of AMD
- Lower cost – manufactured at up to 1/10 the cost of other approaches
D-4517 Alters Pharmacology through Non-Cleavable Dendrimer
| Sunitinib (Sutent™) | D-4517 |
| Liver toxicity (decreased size/increased ALT/AST) | No observed effect |
| Proteinuria, decrease in kidney size (males) | No observed effect |
| Hypoglycemia (females) | No observed effect |
| Decrease in heart size (males) | No observed effect |
Same sunitinib exposure in both groups
D-4517
proprietary Sunitinib analog
