What is diabetes? DIABETES UPDATE Diabetes: An Epidemic. Cost of Care. Traditional Diagnosis: FBS 3/14/18. Diabetes: Magnitude of Complications

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1 What is diabetes? DIABETES UPDATE 2018 Steven Ferrucci, OD, FAAO Chief, Optometry, Sepulveda VA Professor, SCCO/MBKU DM is a chronic disorder characterized by a lack of insulin or increased resistance to insulin Insulin is needed for proper uptake of glucose Clinical result is hyperglycemia Leads to microvascular damage retinopathy nephropathy neuropathy Diabetes: Magnitude of Complications Diabetes: An Epidemic Leading cause of blindness in working age adults Diabetic Nephropathy Diabetic Retinopathy Leading cause of end-stage renal disease Stroke 2- to 4- fold increase in cardiovascular mortality and stroke Cardiovascular Disease Diabetic Neuropathy Leading cause of non-traumatic lower extremity amputations > 30 million people in the United States currently have DM 1 Leading cause of visual loss and new-onset blindness in parents aged 20 to 74 years 1 40% to 45% of Americans diagnosed with DM have some degree of DR 2 84 million more people are at high risk (prediabetes) 3 1. NaRonal Diabetes StaRsRcs Report, Atlanta, GA: NaRonal Center for Chronic Disease PrevenRon and Health PromoRon; NaRonal Eye InsRtute. h_ps://nei.nih.gov/health/diaberc/rernopathy. Accessed January 16, Centers for Disease Control. h_ps:// Accessed January 16, Cost of Care ñ from $172 Billion in 2007 to $245 Billion in ñ41% $ 176 B direct costs $ 69 B indirect In CA alone, $24.5 Billion (July 2015) Medical cost 2.3X higher in pts with DM Care of people with DM accounts for 1 out 5 healthcare dollars in US Traditional Diagnosis: FBS Fasting blood glucose > 126 mg/dl OGTT > 200 mg/dl (2 hour sample) Any random testing >200 mg/dl should be referred for further testing Random testing > 200 mg/dl with symptoms very suggestive of DM 1

2 Newer Diagnosis: HgbA1c Tells blood sugar control over 3 months normal range 4% to 6% Pre-Diabetes 6.5 would be indicative of DM First major change in 30 years In adults and children, not pregnant women Advantages: Convenience: no fasting More accurate: average over 3 months DRUG CLASS Generic (Trade) Biguanide Meeormin (Glucophage ) α-glucosidase Inhibitors Acarbose (Precose ), miglitol (Glyset ) Sulfonylureas Glipizide (Glucotrol ), glyburide (Micronase ), glimepiride (Amaryl ) MegliRnides Repaglinide (Prandin ), nateglinide (Starlix ) TZDs (glitazones) Pioglitazone (Actos), rosiglitazone (Avandia ) DPP-4 Inhibitors (dipeprdyl peprdase-4 inhibitors) SGLT2 Inhibitors (sodium-glucose cotransporter 2 inhibitors) Oral Agents 1 SitaglipRn (Januvia ), saxagliprn (Onglyza ), linagliprn (Tradjenta ), alogliprn (Nesina) Canagliflozin (Invokana ), dapagliflozin (Farxiga ), empagliflozin (Jardiance ) 1. Garber AJ, et al. American AssociaRon of Clinical Endocrinologists comprehensive diabetes management algorithm 2013 consensus statement. Endocr Pract. 2013;19(3): DRUG CLASS GLP-1 Agonists (incrern mimercs) Injectable Non-Insulin Agents 1 Generic (Trade) Amylin Analogs PramlinRde (Symlin ) LiragluRde (Victoza ), exenarde (Bye_a ), exenarde ER (Bydureon ), dulaglurde (Trulicity ), albiglurde (Tanzeum ) DRUG CLASS Generic (Trade) Basal Insulin Glargine (Lantus ), detemir (Levemir ), glargine U-300 (Toujeo ) Rapid-AcRng Insulin Analogs Insulin Therapy 1,2 Aspart (NovoLog ), lispro (Humalog ), glulisine (Apidra ), lispro U-200 (Humalog U-200) Premixed Insulin 70:30, 75:25, 50:50 (Humulin, Novolin ) Regular Insulin U-500 (Humulin R) Inhaled Insulin Afrezza 1. Garber AJ, et al. American AssociaRon of Clinical Endocrinologists comprehensive diabetes management algorithm 2013 consensus statement. Endocr Pract. 2013;19(3): Garber AJ, et al. American AssociaRon of Clinical Endocrinologists comprehensive diabetes management algorithm 2013 consensus statement. Endocr Pract. 2013;19(3): American Diabetes AssociaRon. Insulin basics. h_p:// Accessed October 14, Current recommendations for DM INSULIN PUMP THERAPY COMPANY Medtronic Tandem t:slim, t:flex Insulet OmniPod MiniMed 530G, Paradigm Revel Animas Vibe, OneTouch Ping Accu-chek Insulin Delivery Devices Combo Control BS levels HgbA1c < 7 Control HTN <120/80 Control Cholesterol levels Total cholesterol < 200 No smoking Exercise Yearly foot exams, dental exams, and dilated retinal exams 2

3 Diabetic Retinopathy DuraRon of disease Leading cause of blindness year old 8-12% of all new cases of legal blindness 50,000 Americans legally blind Early diagnosis and treatment can decrease vision loss by 50-60% Factors which influence development of DR duration of disease control of BS Control of HTN Type 1 Pts: ReRnopathy rare in 1 st 3-5 years Aner 10 yrs, 60% have some rernopathy Aner 20 yrs, almost always present 50-60% PDR Type 2: 20% to 39% have rernopathy at Rme of diagnosis Aner 15 years, 60-80% have some rernopathy 20% chance of PDR Control of Blood Sugar Clinically Significant Macular Edema (CSME) DCCT Trial: 1993 Intensive blood glucose control reduced risk of developing retinopathy by 76% Slowed the progression by 54% if already had retinopathy UKPDS: 1998 for every 1% decrease in HgbA1C there is a 35% reduction in risk for retinopathy 34% reduction in retinopathy progressing with good HTN control Characteristics retinal thickening at or within 500 microns (1/3 DD) of center of macula hard exudates at or within 1/3 DD if associated with thickening of adjacent retina thickening greater than 1 DD in size part of which is within 1 DD of center of macular May occur at any stage of retinopathy CSME DME Level of Retinopathy mild NPDR 3% incidence of DME moderate to severe NPDR 40% Proliferative 71% Type 2: Duration and Insulin no insulin 10 years 5% 20 years 15% on insulin 10 years 10% 20 years 30-35% Old definirons being replaced with newer ones based on OCT findings Central Non central OCT best way to evaluate rerna for DME DME responsible for more cases of moderate visual loss in pts with Type 2 DM than DR New treatments 3

4 Widefield Widefield DME: Traditional Treatment FML ETDRS 3711 pts, 22 centers, 10 years Established focal macular laser (FML) as treatment for CSME PROS: Reduced risk of moderate vision loss by 50% 95% chance of maintaining vision when guidelines followed CONS: 12% lost >15 letters at 3 years <3% gained 15 letters Diffuse, chronic, lipid deposits respond poorly Steroids for DME Early 2000 s, before anr-vegf, IVT was looked at treatment for DME Inhibit reducron of PGs Decreases permeability May decrease VEGF proliferaron DRCR.net Ophthalmology September eyes with CSME and VA from 20/40 to 20/320 were evaluated At 2 yrs, laser is more effecrve and has fewer side effects than either 1 or 4 mg intravitreal triamcinolone antivegf Lucentis, Avastin, Eylea Shown in multiple studies to be beneficial for DME RISE 18.1% of pts in sham gained 15 letters vs. 44.8% (0.3 mg) or 39.2% (0.5 mg) 2.6 letters gained in sham vs (0.3mg) or 11.9 (0.5mg) RIDE READ VISTA VIVID OPTIONS Lucentis FDA approved for DME Feb 2015 Eylea FDA approved for DME July 2016 Avastin not FDA approved, but widely used Steroid implants Illuvien FDA approved Sept 2014 Ozurdex FDA approved Sept

5 3/14/18 Protocol T: Lucentis vs Avastin vs Eylea for DME One year Eylea gained 13.3 le_ers LucenRs 11.2 AvasRn 9.7 No starsrcal difference If VA was 20/50 or worse Eylea gained 18.9 LucenRs 14.2 AvasRn 11.8 StaRsRcally, Eylea be_er PDR: Traditional Treatment PRP ETDRS Established benefit of immediate PRP in patients with PDR PROS Showed an overall reduction rate of severe vision loss (ie 5/200) of approximately 50% in treated vs. untreated eyes <4% chance of severe vision loss in 5 years w/ tx CONS Decreased VF Decreased night vision CME Protocol T 2 year results No statistically significant difference between 3 drugs, even in those worse than 20/50 But better acuity with Eylea Bottom line: It may matter which drug May matter more with worse vision Economics may dictate In order to justify use of lucentis/eylea vs avastin, price would have to decrease by 70-80% Protocol S Non-inferior study evaluating Lucentis vs. PRP 55 sites, 203 pts with PRP, 191 with Lucentis, as frequent as q 4 weeks At 2 years: VA improved 2.8 letters with Lucentis vs. 0.2 with PRP More VF loss with PRP:. 531db vs. 213db loss More vitrectomies in PRP group: 15% vs 4% 5

6 DRCRnet Protocol S: Ranibizumab* for PDR at 2 Years Protocol S Lucentis FDA approved April 17, 2017 for monthly treatment of ALL forms of diabetic retinopathy * Monthly intravitreal/sham injecrons q 4 weeks for 1 year or unrl laser; macular laser, if eligible, beginning at month 3; intravitreal/sham every 4 to 16 weeks in year 2. Severe/ Very Severe NPDR Rule: Marked hemes/ma in all 4 quadrants VB in 2 or more quadrants Marked IRMA s in one quadrant Very severe: 2 of the 3 above criteria 50% of pts with this level progress to PDR within 1 year STRONGLY consider referral to retina specialist for anti Vegf Key Messages MPOD is lower in parents with diabetes and lower srll in parents with diaberc rernopathy Higher serum Zeaxanthin/Lutein is associated with 2/3 lower risk of developing type 2 diabetes and early NPDR ECPs should measure and oprmize MPOD in our parents with and at-risk for diabetes Invest Ophthalmol Vis Sci Nov;51(11): Goals Improve retinal metabolism, integrity, and visual function without significantly affecting blood glucose or worsening other labs àavoid hypoglycemia àdon t step on the toes of PCPs and endocrinologists 2 capsules per day, at most Cost less than $1.50/day Who Should Consider Taking DVS Formula? Adults with DM > 5 years Adults with any degree of DR Adults with DM and reduced visual funcron and/or low macular pigment PaRents with sub-oprmal blood glucose control Every parent with diabetes 6

7 Summary of Facts The DiVFuSS formula significantly improved visual funcron, diaberc peripheral neuropathy symptoms, blood lipids and hscrp in parents with established diabetes - without significantly affecrng blood sugar control The DiVFuSS formula significantly increased MPOD The DiVFuSS formula represents a novel & complementary strategy to excellent metabolic control for disruprng the pathobiology of diaberc rernopathy and correcrng visual funcron deficits common in diabetes No adverse events occurred during the study Available as EyePromise DVS Formula Why PaRents Don t Receive Annual Eye Exams As reported by patients diagnosed with diabetes who are not receiving annual eye exams PaRents with visual impairments are more likely to cite cost or lack of insurance as a reason for not receiving an eye exam and less likely to report no need No eye doctor, no transportaron, or could not get appointment Other Cost/lack of insurance No need* *Consisted of have not thought of it and no reason to go Chou CF, et al. Diabetes Care. 2014;37: