Ocular Therapeutix Announces FDA Approval of Supplemental New Drug Application (sNDA) for DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for treatment
âAllergic 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, âcommented
“We appreciate the
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.
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
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.
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.
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 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.
Using steroids after cataract surgery may delay healing and increase the incidence of blistering.
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