Transforming Glaucoma Care with OTX-TP Sustained Release Travaprost Plug
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1 Transforming Glaucoma Care with OTX-TP Sustained Release Travaprost Plug Jonathan H. Talamo, M.D. Chief Medical Officer Glaucoma 360 January 29, 2016 Page 1
2 Forward-Looking Statements Any statements in this presentation about future expectations, plans and prospects for the Company, including statements about the advancement and development of the Company s product candidates, the timing and conduct of the Company s clinical trials, the Company s plans for regulatory submissions, the potential utility of the Company s product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forwardlooking statements within the meaning of The Private Securities Litigation Reform Act of Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forwardlooking statements involve substantial risks and uncertainties that could cause the Company s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing ReSure Sealant, the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company s scientific approach and general development progress, the availability or commercial potential of the Company s product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the Risk Factors section contained in the Company s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company s views as of any date subsequent to the date of this release. Page 2
3 Broad Product Pipeline NDA Filed Sept Announced P3 Results Oct 2015 Announced P2b Results Oct 2015 Reported P2 Data Dec Page 4
4 Glaucoma Treatment Preferences What do you think is the biggest problem with medical therapy for glaucoma? Cost Compliance Side effects Lack of efficacy 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% EyeWorld Magazine, November Monthly Pulse Survey, Glaucoma medical treatment, n=204
5 Glaucoma Treatment Preferences What is your first-line glaucoma eye drop? Prostaglandin Beta blocker Alpha-agonist Carbonic anhydrase inhibitor 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% EyeWorld Magazine, November Monthly Pulse Survey, Glaucoma medical treatment, n=204
6 Glaucoma Treatment Preferences If an injection into the anterior chamber could give you the same efficacy for 3 months as an eye drop taken once a day, which would you prefer? The eye drop The injection 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% EyeWorld Magazine, November Monthly Pulse Survey, Glaucoma medical treatment, n=204
7 Glaucoma Treatment Preferences Assuming that the following medical glaucoma treatments have the same efficacy, which would you pick for yourself? An eye drop taken once per day An insert under the eye lids that needs to be changed monthly An injection into the anterior chamber that lasts 3 months An injection into the vitreous that lasts 6 months 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% EyeWorld Magazine, November Monthly Pulse Survey, Glaucoma medical treatment, n=204
8 Sustained Release Travoprost (OTX-TP) Addresses Compliance Issues Value Proposition Single-placement w 2-3 mo. duration Can be visualized by the patient Preservative-free, minimizes hyperemia Bioabsorbable no removal needed Status Phase 2a S. Africa & Ph 2b U.S. Complete Ph 3 expected to start IMS Health, 2014 Drug-eluting punctum depots are investigational new drugs and not commercially available in the United States or other geographies. Page 11
9 Ease of Insertion and Visualization Page 12
10 Phase 2b Study Design OAG or OHTN IOP 24 and 34mmHg (72 patients in ITT population) Washout at 4 and 5 weeks Patients randomized 1:1 OTX-TP + placebo drops BID Timolol 0.5% BID + Placebo depot (PV) Mean IOP at 60 and 90 days Follow-up continued to Day 150 and beyond based on depot replacements Page 13
11 Double Dummy Study Design 2 Placebo arms (1 drop, 1 plug) to achieve double masking since no active comparator exists for OTX-TP (compare plug w/ drops). Placebo drops in Study Arm (OTX-TP) May REDUCE EFFECT travoprost Placebo plug in Active Comparator arm (T 0.5%) May ENHANCE EFFECT of hypotensive gtts* * Huang TC et al. Am J Ophthalmol 1989; Feb 15;107(2): 151-5; Park JJ et al. Clin Exp Optom 2011; 94: 5: Page 14
12 IOP Reduction from Baseline (mmhg) Phase 2b IOP Reduction Expected Timolol reduction 5-7 mmhg Days Page 15
13 IOP Reduction from Baseline (mmhg) Phase 2b IOP Reduction Expected Timolol reduction 5-7 mmhg OTX-TP: 5.1 mmhg -6-7 ITT, OTX-TP+saline Days Page 16
14 IOP Reduction from Baseline (mmhg) Phase 2b IOP Reduction Expected Timolol reduction 5-7 mmhg OTX-TP: 5.1 mmhg ITT, OTX-TP+saline -7-8 T ½: 7.0 mmhg ITT, -6.7 mmhg post-hoc Timolol+placebo Days Page 17
15 IOP Reduction from Baseline (mmhg) Phase 2b IOP Reduction Expected Timolol reduction 5-7 mmhg OTX-TP: -5.1 mmhg ITT, OTX-TP+saline T ½: 7.0 mmhg ITT, -6.7 mmhg post-hoc Days Timolol+placebo OTX-TP Post Post Hoc Hoc Mean 8 am IOP -5.6 mmhg Page 18
16 Hyperemia Score (0-4) Hyperemia Phase 2a/b Studies 4 OTX-TPa 3 0=None 1=Trace 2=Mild 3=Moderate 4=Severe OTX-TPb Timolol Days Error bars = standard deviation No change in hyperemia with OTX-TP Page 19
17 Phase 2b Conclusions Clinically meaningful IOP up to 90 days Post hoc analysis removing variables of multiple meds, shorter washout showed more effect of OTX-TP and less effect of BID Timolol (-1.1 mm Hg difference) No hyperemia; Good plug retention (88%) at 75 days Duration appropriate for future studies Page 21
18 South Africa Phase 2 Study (2 Month Travoprost Delivery Plug) Page 22
19 Trav 60 S.A. Study Design OAG or OHTN IOP 24 and 34mmHg (20 patients in ITT population) Washout at 5 weeks Single-arm OTX-TP (60 day) Mean IOP and mean IOP change at multiple time points: days 15, 30, 45 and 60 Page 23
20 IOP Change (mmhg) South Africa Phase 2 Study OTX-TP 2 Month Formulation Mean IOP Reduction from Baseline to Day 60 Mean 8 am IOP Reduction = -6.2 mm Hg* Days *Weighted average. Page 24
21 OTX-TP Future Milestones Optimize P3 clinical trial design Q Initiate 1 st Phase 3 OTX-TP in 2016 Stay tuned Page 28
22 Transforming Ophthalmic Care with Sustained Therapies Page 29
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