Ocular Therapeutix Announces FDA Approval of Supplemental New Drug Application (sNDA) for DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for treatment

BEDFORD, Mass.Ocular Therapeutics, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye, announced the United States Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) to expand the DEXTENZA label to add an additional indication for the treatment of itchy eyes associated with allergic conjunctivitis. With this approval, DEXTENZA is the first FDA approved intracanalicular insert administered by a physician capable of delivering a preservative-free drug for the treatment of itchy eyes associated with allergic conjunctivitis with a single administration for up to 30 days. DEXTENZA initially received FDA approval in november 2018 for the treatment of eye pain after ophthalmic surgery, followed by enlargement of the label to also include the treatment of eye inflammation after ophthalmic surgery in June 2019.

“Allergic conjunctivitis is a common condition seen in the offices of eye care providers. We are really excited about this label extension and the potential benefits for patients, ”commented Michael goldstein, MD, president, ophthalmology and chief medical officer. “The use of topical steroids is an important part of our current clinical arsenal in the treatment of allergic conjunctivitis. DEXTENZA can now provide an office-based, physician-administered, preservative-free method of steroid delivery that benefits patients with itchy eyes associated with allergic conjunctivitis. ‘

“We appreciate the FDA hard work and ability to complete their review of our sNDA before the scheduled date October 18 date of PDUFA, ”said Antoine Mattessich, President and CEO of Ocular therapy. “It is difficult to overstate the strategic importance of this label expansion for Ocular therapy. Allergic conjunctivitis, as the first indication in the office, lays the foundation for the rest of our pipeline. ‘

The efficacy of DEXTENZA for the treatment of itchy eyes associated with allergic conjunctivitis was based on three randomized, multicenter, double-blind, parallel-group, vehicle-controlled studies in subjects with a positive history of eye allergies and a reaction. seasonal allergen skin test positive (n = 255). In all three trials, DEXTENZA demonstrated mean eye itch scores lower than the vehicle group at all times throughout the study duration up to 30 days. In two of the three studies, a higher proportion of patients had statistically significant reductions in itchy eyes on day 8, 3 minutes, 5 minutes and 7 minutes after challenge in the DEXTENZA group compared to the vehicle group.

About DEXTENZA

DEXTENZA is FDA approved for the treatment of eye inflammation and pain after ophthalmic surgery and itchy eyes associated with allergic conjunctivitis. DEXTENZA is an intracanalicular corticosteroid insert placed in the tear point, a natural opening in the inner part of the lower eyelid and in the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservative. DEXTENZA is absorbed and exits the nasal lacrimal system without having to be removed.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including herpes simplex epithelial keratitis (dendritic keratitis), vaccinia, chickenpox; mycobacterial infections; fungal diseases of the eye and dacryocystitis.

WARNINGS AND PRECAUTIONS

Increased intraocular pressure

Prolonged use of corticosteroids can lead to glaucoma with damage to the optic nerve, visual acuity and visual field defects. Steroids should be used with caution in case of glaucoma. Intraocular pressure should be monitored during treatment.

Bacterial infection

Corticosteroids can suppress the host response and thus increase the risk of secondary eye infections. In acute purulent conditions, steroids can mask the infection and increase the existing infection.

Viral infection

The use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungal infection

Fungal invasion should be considered in any persistent corneal ulceration when a steroid has been used or is in use. A fungal culture should be taken if necessary.

Delayed healing

Using steroids after cataract surgery may delay healing and increase the incidence of blistering.

On Ocular Therapeutics, Inc.

Ocular Therapeutics, Inc. is a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for eye diseases and conditions using its proprietary bioabsorbable hydrogel formulation technology. Therapeutix’s eyepiece The first commercial drug, DEXTENZA, is an FDA-approved corticosteroid for the treatment of eye inflammation and pain after ophthalmic surgery and itchy eyes associated with allergic conjunctivitis. Therapeutix’s eyepiece Early-stage development assets currently in Phase 1 clinical trials include OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases and OTX-TIC (travoprost intracameral implant) for reduction of intraocular pressure in patients with open primary AMD. angle glaucoma or ocular hypertension. Ocular therapy is currently evaluating OTX-CSI (intracanalicular insertion of cyclosporine) for the chronic treatment of dry eye disease and OTX-DED (intracanalicular insertion of dexamethasone) for the short-term treatment of signs and symptoms of dry eye in clinical trials phase 2. Therapeutix’s eyepiece The first product, ReSure Sealant, is an FDA-approved device for preventing wound leaks in corneal incisions after cataract surgery.

Forward-looking statements

Any statement in this press release regarding the Company’s future expectations, plans and prospects, including the commercialization of DEXTENZA, ReSure Sealant or any of the Company’s product candidates; the commercial launch and effectiveness of DEXTENZA redemption codes; completion of post-approval studies and compliance with related labeling requirements for DEXTENZA and ReSure sealant; the development and regulatory status of the Company’s product candidates, such as the Company’s development and prospects for approval of OTX-CSI for the chronic treatment of dry eye, OTX-DED for the short-term treatment of signs and symptoms of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, and OTX-TKI for the treatment of retinal disease, including wet AMD; the continued development of the Company’s extended delivery hydrogel deposition technology; the size of the potential markets for our product candidates; the potential usefulness of one of the Company’s product candidates; the potential benefits and future operations of the Company’s collaborations, including any potential future costs or payments hereunder; projected net product revenue, market sales and other financial and operational measures of DEXTENZA and ReSure Sealant; the potential market sizes for the indications targeted by the Company’s product candidates, if approved; 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”, “‘predict”, “project”, “target”, “potential”, “will”, “would”, “may”, “should”, “continue”, and similar expressions, constitute forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements. due to various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause preclinical and clinical development programs, future results, performance or Company accomplishments differ materially from those expressed or implied by forward-looking statements. These risks and uncertainties include, among others, the timing and costs involved in the commercialization of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to develop and to successfully market products for the office of ophthalmology establishment, the ability to maintain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain and product sufficiency , procedure and any other reimbursement code for DEXTENZA, initiation, timing, conduct and results of clinical trials, availability of clinical trial data and expectations for regulatory submissions and approvals, the Company’s ability to enter into and fulfill its obligations in the context of collaborations and the performance of its employees in Within the framework of such collaborations, the scientific approach of the Company and the general progress of development, the availability or commercial potential of the Company’s product candidates, the ability of the Company to generate its projected net revenues and its sales on the market on time, if applicable, the adequacy of cash resources, the Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of this debt upon the occurrence of certain events of default, the severity and duration of the COVID-19 pandemic, including its effect on the operations of the Company and relevant regulatory authorities, any need for additional funding and other factors discussed in the ‘Risk Factors’ section contained in the Company’s quarterly and annual reports filed with the Security and Trade Commission. In addition, the forward-looking statements included in this press release represent the views of the Company as of the date of this press release. The Company expects subsequent events and developments to cause a change in the outlook of the Company. However, although the Company may choose to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, unless required by law. These forward-looking statements should not be taken as representing the views of the Company as of a date subsequent to the date of this press release.

Contact:

Investors

Ocular therapy

Donald notman

Financial director

E: dno[email protected]


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