SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
January 12, 2020
Oyster Point Pharma, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
202 Carnegie Center, Suite 109
Princeton, New Jersey 08540
(Address, including zip code, of Registrants principal executive offices)
(Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange
on which registered
|Common Stock, par value $0.001 per share||OYST||The Nasdaq Global Select Market|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
|Item 7.01.|| |
Regulation FD Disclosure.
MYSTIC Study Press Release and Conference Call
On January 12, 2020, Oyster Point Pharma, Inc. (the Company) issued a press release announcing topline data from the MYSTIC Study, the Phase 2 clinical trial of the safety and efficacy of OC-01, the Companys leading product candidate.
In addition, the press release indicated that the management team will host an investor conference call at 8:30 a.m. ET on January 13, 2020 to discuss the topline results. For purposes of the call, and in connection with the announcement described above, the investor slide presentation (the MYSTIC Study Presentation) summarizing the topline results, is posted on the Events & Presentations page within the Investors section of the Companys website at https://investors.oysterpointrx.com. Copies of the press release and the MYSTIC Study Presentation are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated by reference herein.
Channels for Disclosure of Information
Investors and others should note that the Company may announce material information to the public through filings with the Securities and Exchange Commission, the Companys investor relations website (investors.oysterpointrx.com), press releases, public conference calls and public webcasts. The Company encourages investors and others to review the information disclosed through such channels as such information could be deemed to be material information. Please note that this list may be updated from time to time.
The information in this Item 7.01 of this Form 8-K and the attached Exhibits 99.1 and 99.2 are being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
The information contained in the presentation is summary information that is intended to be considered in the context of more complete information included in the Companys filings with the SEC and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company does not undertake any duty or obligation to update or revise the information contained in this report, although the Company may do so from time to time as the management team believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures. For important information about forward looking statements, see the slide titled Disclaimers and Forward Looking Statements in the Exhibit 99.2 attached hereto.
|Item 9.01.|| |
Financial Statements and Exhibits.
|99.1||Press Release, dated January 12, 2020.|
|99.2||Copy of Phase 2 MYSTIC Topline Data Presentation, dated January 13, 2020.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|OYSTER POINT PHARMA, INC.|
|Jeffrey Nau, Ph.D., M.M.S.|
|President and Chief Executive Officer|
Date: January 13, 2020
OYSTER POINT PHARMAS OC-01 NASAL SPRAY MEETS PRIMARY ENDPOINT IN PHASE 2 MYSTIC TRIAL IN SUBJECTS WITH DRY EYE DISEASE
OC-01 nasal spray showed a statistically significant improvement in Schirmers score at Day 84 in both doses tested compared to control
OC-01 nasal spray is a preservative-free, aqueous, nicotinic agonist nasal spray designed to activate the trigeminal parasympathetic pathway to stimulate natural tear production
Conference call and live webcast tomorrow, January 13, at 8:30 a.m. ET to review MYSTIC top-line data
PRINCETON, N.J. January 12, 2020 Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, announced the positive top-line results from its Phase 2 MYSTIC study in Dry Eye Disease.
The results from the MYSTIC study further validate the novel mechanism of action of OC-O1 nasal spray and its ability to stimulate natural tear production via the trigeminal parasympathetic pathway, said Dr. Preeya Gupta, Associate Professor of Ophthalmology at Duke University Eye Center and member of Oyster Point Pharmas medical advisory board. There is a significant need for a treatment approach that can be delivered chronically through a novel route of administration that allows patients to stimulate their own natural tear film and address the underlying disease process.
Efficacy and Safety Results
Results showed a statistically significant improvement in Schirmers score from baseline at Day 84 in both doses as compared to control.
Results for the study eye (primary endpoint) indicated:
The 1.2 mg/ml dose had a mean change in Schirmers score of 11.0 mm (p<0.05 vs. control);
The 0.6 mg/ml dose had a mean change in Schirmers score of 10.6 mm (p<0.05 vs. control).
The vehicle control group had a mean change in Schirmers score of 6.2 mm.
In the eye that was not designated as the study eye (fellow eye), results were consistent (exploratory endpoint):
The 1.2 mg/ml dose had a mean change in Schirmers score of 10.0 mm (p=0.01 vs. control);
The 0.6 mg/ml dose had a mean change in Schirmers score of 8.7 mm (p<0.05 vs. control).
The vehicle control group had a mean change in Schirmers score of 4.5 mm.
The study demonstrated that OC-01 nasal spray was well-tolerated at the two doses tested. The number of subjects reporting any treatment-emergent adverse event (TEAE) was 10 out of 41 (24% percent) in each OC-01 nasal spray dose group and 10 out of 41 (24% percent) in the vehicle control group. There were no reports of serious TEAE in the study and no serious adverse events related to study drug administration. The most common adverse events in the nasal spray groups were blurry vision, sneezing, and headache. All events were mild in the OC-01 nasal spray groups and resolved by the next visit.
We are excited to further validate the ability of OC-01 nasal spray to stimulate an increase in tear film production that is sustained over the course of twice daily dosing for 84 days in subjects with Dry Eye Disease from the MYSTIC study, said Dr. Jeffrey Nau, CEO of Oyster Point Pharma. We look forward to discussing top-line data from our Phase 3 ONSET-2 study in Dry Eye Disease in mid-2020.
The MYSTIC Study
The MYSTIC study was a randomized, single-masked, vehicle-controlled Phase 2 clinical trial that evaluated the safety and efficacy of OC-01 in 123 subjects with Dry Eye Disease at the Asociación para Evitar la Ceguera (APEC) in Mexico City. APEC is the largest specialized ophthalmology hospital in North America by patient volume. The study compared two different doses of OC-01 nasal spray to vehicle control nasal spray (1:1:1 randomization). The goal of this study was to assess the safety and efficacy of twice daily dosing of OC-01 nasal spray administered for 84 days. The pre-specified primary endpoint was the assessment of tear production as measured by mean change in Schirmers score at Day 84 as compared to vehicle control.
Conference Call and Webcast
Oyster Point will host a conference call and webcast to discuss the results of the MYSTIC Phase 2 clinical study tomorrow, January 13 at 8:30 a.m. ET. To access the live call by phone please dial (855) 548-1220 (US/Canada) or (602) 563-8619 (international); the conference ID is 9569009.
A live audio webcast of the event and accompanying slides may also be accessed through the News and Events page of the Investors and News section of the companys website at https://investors.oysterpointrx.com/news-and-events/events-and-presentations.
In addition, the direct webcast registration link is: https://edge.media-server.com/mmc/p/s256m6pe. A replay of the webcast will be available for 7 days following the event.
About OC-01 Nasal Spray
OC-01 is a highly selective nicotinic acetylcholine receptor (nAChR) agonist, being developed as a preservative free nasal spray to treat the signs and symptoms of dry eye disease (DED). The parasympathetic nervous system, the rest and digest system of the body, controls tear film homeostasis partially via the trigeminal nerve which is accessible within the nose. Administered as a preservative-free, aqueous nasal spray, OC-01s novel mechanism of action activates the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film coating is responsible for forming the primary refracting surface of the cornea, as well as protecting and moisturizing the cornea.
About Oyster Point Pharma
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Oyster Point Pharmas lead product candidate, OC-01 nasal spray, a highly selective nicotinic acetylcholine receptor (nAChR) agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal sprays novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit (LFU).
About Dry Eye Disease
Dry eye disease is a chronic, progressive condition that impacts more than 30 million Americans and is growing in prevalence. An estimated 16 million U.S. adults have been diagnosed with dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film. A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye disease can have a significant impact on a persons day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions and on information currently available to us. The forward-looking statements in this press release represent our views as of the date of this press release. These statements may include but are not limited to statements regarding our plans for the anticipated benefits of and safety of our product candidates, the timing, objectives and results of the clinical studies and anticipated regulatory and development milestones. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially are detailed from time to time in the reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties.
LifeSci Advisors, LLC
NASDAQ: OYST January 13, 2020 PHASE II TOPLINE DATA RELEASE MYSTIC The Study In Dry Eye Disease Exhibit 99.2
Disclaimers and Forward Looking Statements This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the current beliefs, expectations and assumptions of Oyster Point Pharma, Inc. (the “Company,” “we” or “our”) regarding the future of its business, its future plans and strategies, clinical results, future financial condition and other future conditions. All statements other than statements of historical facts contained in this presentation, including statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. The words “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: market conditions, the likelihood of our clinical trials demonstrating safety and efficacy of our product candidates, and other positive results; the timing of initiation of our future clinical trials, and the reporting of data from our current and future trials; our plans relating to the clinical development of our product candidates, including the size, number and disease areas to be evaluated; the size of the market opportunity and prevalence of dry eye disease (DED) for our product candidates; our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy; the success of competing therapies that are or may become available; our estimates of the number of patients in the United States who suffer from DED and the number of patients that will enroll in our clinical trials; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; the timing or likelihood of regulatory filings and approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; our plans relating to the further development and manufacturing of our product candidates, including additional indications for which we may pursue; the expected potential benefits of strategic collaborations with third parties and our ability to attract collaborators with development, regulatory and commercialization expertise; existing regulations and regulatory developments in the United States and other jurisdictions; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our financial performance; the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements; our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; our anticipated use of our existing resources and the proceeds from our initial public offering; and other risks described in the “Risk Factors” section included in our public filings that we have made and will make with the Securities and Exchange Commission (SEC). The forward-looking statements in this presentation represent our views as of the date of this presentation. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. We have filed and will file Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, and other documents with the SEC. You should read these documents for more complete information about us. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. This presentation concerns products that are under clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by Federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
Redefining Dry Eye Treatment with a Nasal Spray
There is No Substitute for Natural Tear Film Natural tears contain a complex mixture of lipids, proteins, mucins, and electrolytes Over 1,500 proteins 5+ lipid classes 20+ mucins Growth factors, such as nerve growth factor (NGF) and epidermal growth factor (EGF), found in natural human tears are critical regulators for corneal wound healing Klenkler, B., Sheardown, H., & Jones, L. (2007). Growth factors in the tear film: role in tissue maintenance, wound healing, and ocular pathology. The ocular surface, 5(3), 228-239. Willcox, M. D., Argüeso, P., Georgiev, G. A., Holopainen, J. M., Laurie, G. W., Millar, T. J., ... & Suarez, T. (2017). TFOS DEWS II tear film report. The ocular surface, 15(3), 366-403. Contains growth factors and has anti-inflammatory and antimicrobial properties A healthy tear film lubricates and protects the eyes from injury and infection, washes away foreign particles, and contributes refractive power for clear vision
Tear Film is Produced by the Lacrimal Functional Unit LACRIMAL GLANDS Produce the aqueous which contains proteins, enzymes, antibodies and growth factors that are cytoprotective, anti-inflammatory, and anti-microbial. aqueous mucins lipid layer MEIBOMIAN GLANDS Produce the lipid layer which reduces evaporation and promotes tear film stability. GOBLET CELLS Produce mucins which bind water from the aqueous layer and allow for spreading of the aqueous layer over the ocular surface and help stabilize the tear film.
Loss of Tear Film Leads to Progression of Dry Eye Disease Epithelial Cells Mucin Aqueous Lipid Healthy Ocular Surface Tear Film Homeostasis Loss of Tear Film Homeostasis Fundamental Characteristic of DED Cycle of Dry Eye Disease Leads to Inflammation and Cell Damage Increased Evaporation Decreased Tear Volume Irritation Inflammation & Cell Damage Tear Deficiency & Instability RESTASIS®, XIIDRA® & other DED pipeline Product candidates primarily address DED further down disease continuum
OC-01 Breaks this Cycle to Re-Establish Natural Tear Film Production through its Novel MOA Epithelial Cells Mucin Aqueous Lipid Healthy Ocular Surface Tear Film Homeostasis Loss of Tear Film Homeostasis Fundamental Characteristic of DED Cycle of Dry Eye Disease Leads to Inflammation and Cell Damage Increased Evaporation Decreased Tear Volume Irritation Inflammation & Cell Damage Tear Deficiency & Instability OC-01 is designed to address the fundamental characteristic of DED by reestablishing natural tear film production to improve the signs and symptoms of DED
Nasal Delivery is Critical to the Novel MOA The trigeminal nerve provides the pathway for parasympathetic stimulation of the Lacrimal Functional Unit (LFU) to promote complete natural tear film The trigeminal nerve is accessible within the nasal cavity and can be activated by stimulating nicotinic acetylcholine receptors (nAChR) 1Gupta, A., Heigle, T., & Pflugfelder, S. C. (1997). Nasolacrimal stimulation of aqueous tear production. Cornea, 16(6), 645-648. Parasympathetic Nervous System controls tear film homeostasis 34% of basal tear production is due to inhaling air through the nose1
OC-01 is a Selective Nicotinic Agonist Preservative-free nasal spray containing the selective nicotinic acetylcholine receptor agonist, varenicline. Binds to receptors located on the trigeminal nerve readily accessible within anterior portion of the nasal cavity to open ion channels and depolarize the nerve. Nerve is activated, and lacrimal functional unit is stimulated to produce natural tears.
OC-01 Nasal Spray Clinical Development Program Dry Eye Disease PHASE 1 PHASE 2b PHASE 2 PHASE 3 PK Study 28-Day Safety & Efficacy Long-term 84 Day Safety & Efficacy 28-Day Efficacy & Safety Complete Complete Complete Top-Line Expected Mid-2020 Planning OC-01 label expansion for contact lens intolerance and ocular surface preparation for refractive surgeries MYSTIC Top-line safety & efficacy data from 84-Day dosing in the MYSTIC Trial
Phase 2 Study: Evaluating Long-term Safety and Efficacy Study Rationale: Evaluate long-term (Day 84) safety and efficacy of nicotinic agonist stimulation of the trigeminal parasympathetic pathway Met the Primary Endpoint of Mean Change in Schirmer’s Score vs. Control at Day 84 Statistically significant improvements in Schirmer’s score compared to placebo at Day 84 at both 0.6 mg/ml and 1.2 mg/ml dose groups MYSTIC
Single center, randomized, controlled, single-masked clinical trial to evaluate the chronic efficacy of OC-01 nasal spray on signs of dry eye disease OC-01 Phase 2 Study Design Diagnosed Dry Eye Disease >22 yrs old Schirmer’s Score ≤10 mm Placebo (Vehicle Control) 0.6 mg/ml OC-01 Nasal Spray 1.2 mg/ml OC-01 Nasal Spray n=41 n=41 n=41 Randomized 1:1:1 BID for 84 Days N=123 Schirmer’s Score Results Interpretation 15–25mm = Normal Range <10mm = Inadequate 10–14mm = Suspect Low Tears
MYSTIC Subject Demographics Mean Age at Randomization (years) Sex Male n (%) Female n (%) Race White n (%) Black or African American n (%) Asian n (%) Other n (%) Ethnicity Not Hispanic or Latino n (%) Hispanic or Latino n (%) Age Range (min, max) Mean Baseline Schirmer’s Test (with anesthesia, mm) Placebo (n=41) 0.6 mg/ml (n=41) 1.2 mg/ml (n=41) Total (n=123) 55.8 8 (19.5) 33 (80.5) 0 0 0 41 (100) 0 41 (100) 26, 77 5.3 51.4 9 (22) 32 (78) 0 0 0 41 (100) 0 41 (100) 28, 74 5.5 54.2 6 (14.6) 35 (85.4) 0 0 0 41 (100) 0 41 (100) 28, 74 5.4 53.8 23 (18.7) 100 (81.3) 0 0 0 123 (100) 0 123 (100) 26, 77 5.4
Study Eye- Primary Endpoint Statistically Significant Improvement In Schirmer’s Score at Day 84 Mean Change in Schirmer’s Score* (mm) Study Eye Mean Change from Baseline in Schirmer’s Score (mm) Intent To Treat-Last Observation Carried Forward * ANCOVA, Least Squares mean Intent To Treat- Observed * ANCOVA, Least Squares mean p=0.01 n=41 n=41 n=41 n=32 n=35 n=29 p=0.01 P<0.05 P<0.05 LOCF Analysis Observed Analysis
Fellow Eye- Exploratory Statistically Significant Improvement In Schirmer’s Score at Day 84 Mean Change in Schirmer’s Score* (mm) Fellow Eye Mean Change from Baseline in Schirmer’s Score (mm) Intent To Treat-Last Observation Carried Forward * ANCOVA, Least Squares mean Intent To Treat- Observed * ANCOVA, Least Squares mean n=41 n=41 n=41 n=32 n=35 n=29 p=0.07 p=0.01 P<0.05 P<0.05 LOCF Analysis Observed Analysis
Study Eye Showed Early and Sustained Improvement In Schirmer’s Score to Day 84 Mean Change in Schirmer’s Score* (mm) Highlights: Early Improvement in mean change in Schirmer’s score for both groups in the study eye Consistent tear film production with twice daily dosing at all visits to Day 84 Study Eye Mean Change from Baseline in Schirmer’s Score (mm) Intent To Treat- Observed * Observed mean n=31 n=34 n=33 n=31 n=34 n=31 n=32 n=35 n=30 n=32 n=35 n=29
Magnitude of Tear Production Consistent with Prior Studies of OC-01 at Day 28 MYSTIC Intent To Treat- Observed * ANCOVA, Least Squares mean Mean Change in Schirmer’s Score* (mm) Mean Change in Schirmer’s Score* (mm) n=46 n=40 n=34 n=31
OC-01 Safety and Tolerability Profile Adverse Event (Preferred Term) OC-01 (0.6 mg/mL) (n=41) n (%) OC-01 (1.2 mg/mL) (n=41) n (%) Placebo (vehicle control) (n=41) n (%) Visual Acuity Reduced 4 (9.8) 1 (2.4) 0 Sneeze after any instillation 2 (4.9) 3 (7.3) 2 (4.9) Headache 2 (4.9) 2 (4.9) 0 Throat irritation after any instillation 2 (4.9) 0 0 Nosebleed 0 0 2 (4.9) Nasal Discomfort 1 (2.4) 0 1 (2.4) All events transient and resolved by the next visit All drug related events mild Adverse Events Potentially Related to OC-01 Administration Events in >1 subjects in any group No Serious Adverse Events
Next: Pivotal Phase 3 Data; Topline Data On Track for Mid-2020 Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease Diagnosed Dry Eye Disease Schirmer’s Score ≤10 mm OSDI ≥23 Placebo (Vehicle Control) 0.6 mg/ml OC-01 Nasal Spray 1.2 mg/ml OC-01 Nasal Spray n=250 n=250 n=250 Randomized 1:1:1 BID for 28 Days N=750 Primary (sign) Endpoint: Schirmer’s Score at day 28 Secondary (symptom) Endpoints: Visual analog eye dryness score (EDS) in CAE at day 28 Visual analog eye dryness score (EDS) in at day 28 Additional Schirmer’s measurements Fluorescein corneal staining
OC-01 Nasal Spray Expected Timeline to Approval Enrollment Complete- Q3 2018 Enrollment Complete- 1H 2020 Topline Data (Day 28)- MID 2020 NDA Submission - 2H 2020 NDA Approval - 2H 2021 New Drug Application Enrollment Complete - Q3 2019 Topline Data - Q4 2019 MYSTIC Enrollment Complete - Q3 2019 Topline Data (Day 84) - Q1 2020 Topline Data- Q4 2018