OCUL Ocular Therapeutix Inc.

Upcoming Catalysts

Drug Pipeline

Latest News

1. 20 January 2021 Ocular Therapeutix™ Presents Interim Topline Data from the Phase 1 Clinical Trial of OTX-TIC in Patients with Primary Open Angle Glaucoma or Ocular Hypertension at the 10th Annual Glaucoma 360 New Horizons Forum

   Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced plans to present data on OTX-TIC, a travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension at the Glaucoma 360 New Horizons Forum being held virtually on January 30^th. As part of the event, Michael Goldstein, M.D., M.B.A., President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix, has narrated a presentation on the OTX-TIC Phase 1 study that is available today and can be accessed on the "Events and Presentations" section of the Ocular Therapeutix website…

   Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced plans to present data on OTX-TIC, a travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension at the Glaucoma 360 New Horizons Forum being held virtually on January 30^th. As part of the event, Michael Goldstein, M.D., M.B.A., President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix, has narrated a presentation on the OTX-TIC Phase 1 study that is available today and can be accessed on the "Events and Presentations" section of the Ocular Therapeutix website.

   The Phase 1, prospective, multi-center, open-label, clinical trial is intended to evaluate safety, biological activity, durability, and tolerability of OTX-TIC for the reduction of elevated intraocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension. Interim data presented at Glaucoma 360 are from the four fully enrolled cohorts (cohort 1=5 subjects, cohort 2=4 subjects, cohort 3=5 subjects, and cohort 4=5 subjects). Formulations of cohort 3 and 4 hydrogel implant include composition for faster dissolution when compared with cohorts 1 and 2.

   In this Phase 1 clinical trial, all cohorts experienced a mean reduction in IOP from baseline of 7-11 mm Hg with onset of action as early as two days after insertion. Many subjects across the four cohorts demonstrated durability of activity of 6 months or longer with a single implant. Overall, no serious ocular adverse events were noted. The hydrogel drug delivery system consistently biodegraded in 5-7 months in cohorts 1 and 2 and in 3-5 months in cohorts 3 and 4. No meaningful changes in endothelial cell counts or pachymetry were observed across the cohorts. Evaluation remains ongoing for cohort 4. As is typical for early stage clinical trials, this trial is not powered to measure efficacy endpoints with statistical significance.

   "Compliance with topical drop therapy remains a clinical problem in the treatment of glaucoma and represents a large unmet medical need. OTX-TIC was developed to deliver travoprost for an extended duration of time and, if shown to be safe and effective, represents a possible solution to this problem. Continued long-term evaluation is ongoing but we are very excited by what we have seen with the early results from this trial," commented Dr. Goldstein. "We continue to believe that OTX-TIC has the potential for a unique and differentiated drug product profile. Based on these data we continue to plan to initiate a Phase 2 clinical trial in mid-2021."

   About OTX-TIC

   OTX-TIC is designed to be a bioresorbable intracameral implant containing micronized travoprost that is injected into the anterior chamber of the eye and is intended for patients with glaucoma or ocular hypertension with a target duration of drug delivery of four months or longer. OTX-TIC is designed to directly address compliance issues by delivering travoprost over the course of several months with a single implant.

   About Glaucoma

   Glaucoma is a progressive and highly individualized disease in which elevated levels of IOP are associated with damage to the optic nerve, which results in irreversible vision loss. According to the World Health Organization, glaucoma is the second leading cause of blindness in the world. The Glaucoma Research Foundation estimates that over three million Americans have glaucoma.

   To lower IOP, physicians typically initiate treatment by prescribing drugs administered as eye drops. These drugs either decrease fluid production or enhance fluid drainage. The classes of topical drugs used to treat glaucoma include prostaglandin analogs, or PGAs, beta-blockers, alpha-adrenergic agonists and carbonic anhydrase inhibitors. PGAs are the most widely prescribed class of drugs for glaucoma and are considered first-line glaucoma treatment. PGAs reduce IOP by enhancing the clearance and drainage of ocular fluid. The most frequently prescribed PGA is once-daily latanoprost, although travoprost, unoprostone and bimatoprost are also frequently used in the management of open-angle glaucoma. In cases where glaucoma is not easily managed by a drug regimen, surgical or laser treatments may be undertaken.

   According to IMS Health data, approximately 35.6 million prescriptions were filled in the United States in 2019 for drugs administered by eye drops for the treatment of glaucoma, resulting in sales of approximately $3.3 billion. A typical prescription provides approximately one month of treatment. We expect prescription volume to grow, in large part as a result of the aging population. According to IMS Health, PGAs accounted for approximately half of the prescription volume in the glaucoma market in 2019.

   About Ocular Therapeutix, Inc.

   Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix has recently filed a Phase 2-enabling investigational new drug application for OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

   Forward Looking Statements

   Any statements in this press release about future expectations, plans, and prospects for the Company, including its presentation at future scientific or medical conferences; the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources 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 forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking 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, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing 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 Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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 press 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 except as required by law. 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 press release.

   

   View source version on businesswire.com: https://www.businesswire.com/news/home/20210120005360/en/

   View Full Article Hide Full Article
2. 07 January 2021 Ocular Therapeutix™ Promotes Michael Goldstein, MD, MBA, to President, Ophthalmology and Appoints Rabia Gurses Ozden, MD as Senior Vice President, Clinical Development

   Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the promotion of Michael Goldstein, MD, MBA, to the newly created position of President, Ophthalmology. Dr. Goldstein will continue to report to Antony Mattessich, Ocular's President and Chief Executive Officer. With this promotion, Dr. Goldstein will be responsible for clinical operations and in that capacity will maintain his role as Chief Medical Officer. He will also be responsible for commercial operations in alignment with the overall Company strategy. The Company also announced the appointment of Rabia Gurses Ozden, MD, as Senior…

   Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the promotion of Michael Goldstein, MD, MBA, to the newly created position of President, Ophthalmology. Dr. Goldstein will continue to report to Antony Mattessich, Ocular's President and Chief Executive Officer. With this promotion, Dr. Goldstein will be responsible for clinical operations and in that capacity will maintain his role as Chief Medical Officer. He will also be responsible for commercial operations in alignment with the overall Company strategy. The Company also announced the appointment of Rabia Gurses Ozden, MD, as Senior Vice President (SVP), Clinical Development. As SVP, Clinical Development, Dr. Ozden is responsible for leading the clinical development of Ocular Therapeutix's current and growing pipeline of indications focusing on the front and back of the eye. The strategic appointments are expected to play a key role in supporting Ocular's future growth and reflect Ocular's commitment to developing innovative therapies for diseases and conditions of the eye.

   "2020 has been a year of exciting growth for Ocular Therapeutix with the commercial success of DEXTENZA and with the development of our leading ophthalmology pipeline," said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "Recognizing the great opportunity to build upon our progress, I am thrilled to be expanding the organization with the promotion of Mike and with the addition of Rabia to our clinical team. Mike has played a key role in our recent successes, and I believe his strong leadership will continue to drive further success and future growth."

   "I am really excited about the work Ocular Therapeutix is doing in ophthalmology and our potential. We aim to keep developing exciting products to fulfill unmet needs in ophthalmology to benefit patients and to continue developing a best-in-class commercial team to deliver those products to market," said Michael Goldstein, Chief Medical Officer and President, Ophthalmology. "I would also like to welcome Rabia to the Ocular team. We are fortunate to attract a talent like Rabia who brings to Ocular a proven track record and broad therapeutic expertise in ophthalmology with subspecialty training in glaucoma."

   Dr. Ozden has over 15 years of experience in clinical development, clinical operations, and pharmacovigilance in pharmaceutical and medical device programs. Dr. Ozden has had numerous interactions with regulatory agencies for clinical support in product filings, clinical endpoint developments and label negotiation. Prior to joining Ocular, Dr. Ozden most recently served as the Chief Development Officer at Akouos, Inc. Previously, Dr. Ozden served as Chief Medical Officer of Nightstar Therapeutics plc, a gene therapy company focused on rare inherited retinal diseases, which was acquired by Biogen. She has held leadership positions at Applied Genetic Technologies Corporation and GlaxoSmithKline, and earlier in her career held clinical development and operations roles at Quark Pharmaceuticals, Bausch & Lomb Pharmaceuticals and Carl Zeiss Meditec AG. Dr. Ozden received her M.D. from Hacettepe University School of Medicine, completed her ophthalmology residency at Ankara University School of Medicine, and her clinical fellowship in Glaucoma at the New York Eye and Ear Infirmary.

   About Ocular Therapeutix, Inc.

   Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

   Forward Looking Statements

   Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources 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 forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking 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, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing 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 Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, any additional financing needs 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 press 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 except as required by law. 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 press release.

   

   View source version on businesswire.com: https://www.businesswire.com/news/home/20210107005262/en/

   View Full Article Hide Full Article
3. 28 December 2020 Ocular TherapeutixTM Announces Exercise of Underwriters' Option to Purchase Additional Shares

   Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the underwriters of its public offering that closed on December 18, 2020, have exercised in full their option to purchase an additional 558,750 shares of its common stock at the public offering price of $21.50 per share, less underwriting discounts and commissions. After giving effect to the option closing, the total number of shares of common stock sold by the Company in its public offering increased to 4,283,750 shares, which resulted in aggregate gross proceeds of approximately $92.1 million and aggregate net proceeds of approximately…

   Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the underwriters of its public offering that closed on December 18, 2020, have exercised in full their option to purchase an additional 558,750 shares of its common stock at the public offering price of $21.50 per share, less underwriting discounts and commissions. After giving effect to the option closing, the total number of shares of common stock sold by the Company in its public offering increased to 4,283,750 shares, which resulted in aggregate gross proceeds of approximately $92.1 million and aggregate net proceeds of approximately $86.1 million after deducting underwriting discounts and commissions and estimated offering expenses.

   Jefferies LLC and Piper Sandler & Co. acted as joint book-running managers for the offering. Raymond James & Associates, Inc. and JMP Securities LLC acted as co-managers for the offering.

   The offering was made pursuant to a shelf registration statement on Form S-3 that became effective upon filing with the Securities and Exchange Commission (SEC). The offering was made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. Electronic copies of the final prospectus supplement and the accompanying prospectus for the offering are available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, by telephone: (877) 821-7388, or by email: or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: .

   This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

   About Ocular Therapeutix, Inc.
   
   Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA^®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix is evaluating product candidates for the treatment of other ocular conditions including various retinal diseases, glaucoma, dry eye disease, and allergic conjunctivitis.

   

   View source version on businesswire.com: https://www.businesswire.com/news/home/20201228005061/en/

   View Full Article Hide Full Article
4. 22 December 2020 Ocular Therapeutix™ Announces Submission to the FDA of a Supplemental New Drug Application for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

   PDUFA Target Action Date Anticipated for October 2021

   Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the submission of the supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.

   "We are excited to share the allergic conjunctivitis data with the FDA and feel this sNDA supports an expanded label. If approved, the…

   PDUFA Target Action Date Anticipated for October 2021

   Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the submission of the supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.

   "We are excited to share the allergic conjunctivitis data with the FDA and feel this sNDA supports an expanded label. If approved, the sNDA would reflect the second expansion of the DEXTENZA label and would include the first indication for DEXTENZA treated primarily in the ophthalmology office setting," said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. "It is estimated that up to 10 million^1,2,3 people in the U.S. annually seek medical attention for the inflammatory response associated with allergic conjunctivitis caused by both seasonal and perennial allergens, representing a discrete and significant potential market for DEXTENZA beyond its current use in the surgical setting. From a business perspective, ocular itching associated with allergic conjunctivitis is our first potential indication in the treatment of an ocular surface disease, paving the way for our two Phase 2 clinical programs in the treatment of dry-eye disease."

   The efficacy of DEXTENZA for the treatment of ocular itching was evaluated in four vehicle-controlled clinical trials for subjects with a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens (n=323). The sNDA offers data that Ocular believes supports that DEXTENZA demonstrated superiority to placebo vehicle for the treatment of ocular itching due to allergic conjunctivitis as evidenced by statistically significant differences in a pooled analysis of three well controlled Phase 3 clinical trials as well as in the Phase 2 clinical trial. At the primary endpoint for the pooled analysis of the three Phase 3 clinical trials (Day 8), ocular itching scores favored DEXTENZA treated subjects compared with placebo vehicle treated subjects at all three timepoints: 3 min (1.85 vs 2.55, p value = <0.0001 ), 5 min (1.90 vs 2.63, p value = <0.0001 ) and 7 min (1.84 vs 2.61, p value = <0.0001 ). In addition, it is submitted that treatment with DEXTENZA consistently resulted in lower ocular mean itching scores relative to placebo vehicle at all other study visits throughout the duration of the respective studies.

   DEXTENZA was observed to have a favorable safety profile and be generally well-tolerated in the allergic conjunctivitis, ocular inflammation and pain clinical program populations. The most common ocular adverse events seen in the pooled analysis of the allergic conjunctivitis studies were: increased intraocular pressure (n=6), increased lacrimation (n=2), eye discharge (n=2) and reduced visual acuity (n=2). The most common non-ocular adverse events seen were: headache (n=2), nasopharyngitis (n=1), gastroenteritis viral (n=1), dermatitis contact (n=1), and oropharyngeal pain (n=1).

   "The use of topical steroids is an important part of the clinical armamentarium in the treatment of a patient with allergic conjunctivitis," said Michael Goldstein, MD, MBA, Chief Medical Officer of Ocular Therapeutix. "As DEXTENZA is physician-administered and can't be overused by patients, it provides a potentially safer method of steroid delivery. In addition, unlike current therapeutic options, DEXTENZA is a preservative-free steroid which may be a benefit for patients with allergic conjunctivitis who already have a compromised ocular surface."

   The Company has received acceptance of the sNDA submission to the FDA and anticipates a target action data under the Prescription Drug User Fee Act, commonly known as PDUFA, in October of 2021.

   About DEXTENZA

   DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

   The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial evaluating DEXTENZA for the treatment of post-surgical inflammation and pain of the eye prior to its approval. Overall, 567 subjects were exposed to DEXTENZA in such clinical trials. The most common ocular adverse reactions in subjects treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

   Please see Important Safety Information and full Prescribing Information at www.DEXTENZA.com.

   About Ocular Therapeutix, Inc.

   Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has completed Phase 3 clinical trials evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix is currently developing OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease and, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to seal corneal incisions following cataract surgery.

   ¹ Leonardi A, Castegnaro A, Valerio ALG, Lazzarini D. Epidemiology of allergic conjunctivitis: clinical appearance and treatment patterns in a population-based study. Curr Opin Allergy Clin Immunol. 2015;15(5):482-488.
   
   ² Rosario N, Bielory L. Epidemiology of allergic conjunctivitis. Curr Opin Allergy Clin Immunol. 2011;11(5):471-476
   
   ³ Ora website, An Update on Ocular Allergy Trends, 2019 Ora, Inc., www.oraclinical.com

   Forward Looking Statements

   Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources 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 forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking 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, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing 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 Company's ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company's ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations, the 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 press 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 except as required by law. 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 press release.

   

   View source version on businesswire.com: https://www.businesswire.com/news/home/20201222005191/en/

   View Full Article Hide Full Article
5. 15 December 2020 Ocular TherapeutixTM Announces Pricing of Public Offering of Common Stock

   Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 3,725,000 shares of its common stock at a public offering price of $21.50 per share for gross proceeds of approximately $80.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company has granted the underwriters of the offering a 30-day option to purchase up to an additional 558,750 shares in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the…

   Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 3,725,000 shares of its common stock at a public offering price of $21.50 per share for gross proceeds of approximately $80.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Company has granted the underwriters of the offering a 30-day option to purchase up to an additional 558,750 shares in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by the Company. The offering is expected to close on or about December 18, 2020, subject to the satisfaction of customary closing conditions.

   Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. Raymond James & Associates, Inc. and JMP Securities LLC are acting as co-managers for the offering.

   The offering is being made pursuant to a shelf registration statement on Form S-3 that became effective upon filing with the Securities and Exchange Commission (SEC). The offering is made only by means of a prospectus supplement and the accompanying prospectus that form a part of the registration statement. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents the Company has filed with the SEC, which are incorporated by reference in the prospectus supplement and the accompanying prospectus for the offering and which provide more complete information about the Company and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus for the offering are available on the website of the SEC at www.sec.gov, and the final prospectus supplement relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement, the final prospectus supplement, when available, and the accompanying prospectus relating to this offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, by telephone: (877) 821-7388, or by email: or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: .

   This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

   About Ocular Therapeutix, Inc.

   Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix is evaluating product candidates for the treatment of other ocular conditions including various retinal diseases, glaucoma, dry eye disease, and allergic conjunctivitis.

   Forward Looking Statements

   Any statements in this press release about future expectations, plans, and prospects for the Company, including the Company's expectations and plans regarding the underwritten public offering and the Company's anticipated use of proceeds of the offering, 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 forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking 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, the severity and duration of the COVID-19 pandemic including its effect on the Company's and relevant regulatory authorities' operations and the financial markets, the satisfaction of customary closing conditions related to the proposed underwritten public offering, the need for additional financing or other actions and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement related to the proposed underwritten public offering and 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 press 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 except as required by law. 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 press release.

   

   View source version on businesswire.com: https://www.businesswire.com/news/home/20201215006198/en/

   View Full Article Hide Full Article