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Glaucoma: Clinical Drug Studies and Clinical Trials; Poster P‐S‐094 Maintenance of IOP‐Reduction for 6 Months with a Single Dose of a Novel Topically Applied Bimatoprost Ocular Insert in Patients with Open‐Angle Glaucoma or Ocular Hypertension Ivan Goldberg1, 2, 3,*, Guna Laganovska4, Renuka Bathija5, Michael Coote6, Yair Alster7, Anne Brody Rubin7, Eugene De Juan, Jr.7, Charles Semba7 1Discipline of Ophthalmology, University of Sydney, 2Glaucoma Unit, Sydney Eye Hospital, 3Eye Associates of Sydney, Sydney, Australia, 4Pauls Stradins University Hospital, Riga, Latvia, 5Waverley Eye Clinic, Melbourne, Australia, 6Melbourne Eye Specialists, Melbourne, Australia, 7ForSight VISION5, Inc., Menlo Park, CA, United States *Corresponding Author: Ivan Goldberg, [email protected] RESULTS BACKGROUND Reduction of IOP is the only proven treatment to slow progression of glaucoma; however, a common problem is poor patient adherence to daily medications. Lack of adherence has correlated with progression of vision loss. An unmet need exists for alternatives to daily eye drops in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) to improve treatment adherence. 43 subjects were screened and 27 subjects met eligibility (Table 1). Mean diurnal IOP at washout was 23.9 mmHg and a mean diurnal IOP reduction of 4.7-6.5 mmHg was observed for 6 months (Figure 1). 8 subjects did not complete the full 6-month treatment due to unintentional early exit by investigator at month 4 (N=3), inadequate IOP control at month 5 (N=3), and discomfort with insert (N=2; 1 at week 2, 1 at week 6). A novel sustained-release bimatoprost ocular insert (Insert) that allows continuous administration of bimatoprost for up to 6 months with a single applied dose was evaluated. The Insert is constructed as a polymer / bimatoprost matrix in a soft, compliant ring (~26 mm diameter) that is applied to the ocular surface in the clinic and maintained under the eyelids. The Insert is designed to elute preservative-free bimatoprost into the tear film. Ocular adverse events occurring in more than 3 subjects included eye discharge (N=17), epiphora (N=10), hyperemia (N=9 subjects), and discomfort (n=7). There was one non-ocular serious adverse event (whiplash injury from motor vehicle accident) not-related to study treatment. Table 1. Study Demographics Our purpose is to present feasibility results with a 13 mg Insert in OAG/OHT patients treated up to 6 months. Two similar Phase 1b single-arm, open-label studies were conducted at a total of four centers (in Australia and Latvia) evaluating the safety and exploratory efficacy of a single applied 13 mg Insert (OU) without concomitant topical eye drops in patients with OAG/OHT treated up to 6 months. Bimatoprost ocular insert (HeliosTM): 1. Insert is placed under upper lid: Screening 43 (86 eyes) 70 (50-85) 22 (51%) a,b 31 (62 eyes) 69 (50-85) 15 (48%) 27 (54 eyes) 69 (50-85) 12 (44%) Per Protocol aOf the subjects who wore the 13 mg insert, 6 had also worn the lower dose inserts used earlier in one of the two studies. bOf the subjects who wore the 13 mg insert,3 subjects exited for discomfort prior to a full diurnal IOP at Week 2 and did not have evaluable IOP data; 1 subject was censored by medical monitor for mid-study addition of systemic steroids. Key eligibility criteria were adult patients with OAG/OHT controlled on monotherapy (IOP ≤18 mmHg) and washout IOP ≥22 and ≤34 mmHg; subjects with prior incisional or laser surgery for glaucoma were excluded. Following a 4-week washout period, eligible patients received a 13 mg Insert (OU) and were followed for up to 6 months. Study visits were at weeks 2, 6; months 3, 4, 5, 6. Diurnal IOP (T=0, 3 and 6hrs), slit-lamp, BCVA, adverse events were collected at all visits. The Insert was removed after 6 months. Mean diurnal IOP measures were assessed through 6 months using descriptive analyses of observed evaluable data (per protocol). Fig. 1. Mean Diurnal Intraocular Pressure (IOP) with Insert (N = 27 subjects, per protocol population) 26.0 24.0 mmHg (S.E.) The bimatoprost ocular insert is applied after a drug washout period and IOP was observed for 6 months following the single application (OU). Female, n (%) Enrolled METHODS INSERT & PLACEMENT Subjects (N) Age, mean (range) 22.0 20.0 18.0 16.0 14.0 2. Diurnal Average N (eyes) Screening Washout Week 2 Week 6 Week 12 Week 16 Month 5 Month 6 16.3 23.9 17.4 18.2 18.8 18.7 19.2 18.8 54 54 52 52 50 49 43 37 Per Protocol Analysis Cohort: At 6 months, of the 54 eyes exposed to the 13 mg bimatoprost inserts, 37 remained in the efficacy analysis. Of the 17 eyes not included in the analysis, 8 subjects (16 eyes) exited early (reasons cited above); 1 subject (1 eye) was censored after placement of a new insert (fresh dose) when the initial insert fell out. Insert is placed under lower lid: 3. Properly placed insert slightly visible at caruncle: 4. CONCLUSIONS A single applied Insert in patients with OAG/OHT provided: • Six months of clinically significant IOP reduction from a single Insert (OU); • Mean diurnal reduction of IOP was 4.7 to 6.5 mmHg from washout; • No unexpected safety events were observed. The results demonstrate initial feasibility of a sustained delivery of topical bimatoprost. DISCLOSURES Images courtesy of ForSight VISION5 Goldberg (Consultant to ForSight VISION5); Alster, de Juan, Rubin, and Semba (ForSight VISION5 Founders or Employees)