Reference: DEXTENZA [package insert]. Bedford, MA: Ocular Therapeutix, Inc; 2021.
Reference: DEXTENZA [package insert]. Bedford, MA: Ocular Therapeutix, Inc; 2021.
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis.
Intraocular Pressure Increase – Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during treatment.
Bacterial Infections – Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection.
Viral Infections – Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungal Infections – Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.
Delayed Healing – Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Other Potential Corticosteroid Complications – The initial prescription and renewal of medication order of DEXTENZA should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Ocular Inflammation and Pain Following Ophthalmic Surgery
The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), intraocular pressure increased (6%), visual acuity reduced (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse reaction was headache (1%).
Itching Associated with Allergic Conjunctivitis
The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: intraocular pressure increased (3%), lacrimation increased (1%), eye discharge (1%), and visual acuity reduced (1%). The most common non-ocular adverse reaction was headache (1%).
DEXTENZA is a corticosteroid indicated for:
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Ocular may have additional privacy notices or terms that are tailored and more specific for the different ways your personal information is collected. For example, clinical trial subjects are provided with separate notices related to their personal information collected for the trial. Employment applicants may also be provided with a separate privacy notice.
The information we receive, and how we use it, depends on the nature of your relationship with us and requirements of applicable laws. The term “personal information” can have different meanings. In general, we use the term “personal information” to mean information that can uniquely identify you, but we will treat information we collect from you as personal information wherever necessary.
We may collect and use the following different categories of information about you, which includes personal information and non-personal information:
• Profile Data such as information regarding your communication preferences, and feedback and survey responses.
Direct interactions. You may give us your personal information, such as Identity Data, Contact Data and Financial Data by filling in forms or by corresponding with us by mail, phone, and email or otherwise. This includes personal information you provide when you, for example:
Automated interactions. As you interact with our websites or use our intranet, and in some emails we may send each other, we may automatically collect Technical Data. This can include your preferences (like, language and the location you are in). We may also collect information about your visits to our websites, such as the length of visits to certain pages and page interaction information. Automatic technologies we use may include web server logs, cookies, pixels and web beacons that are described in “Cookies and Other Tracking Mechanisms” below.
Third parties (or publicly available sources). We may receive categories of personal information about you from various third parties and public sources as set out below, such as:
Ocular and/or the service providers, vendors and other third parties we hire to perform services on our behalf may use your personal information, for example,
We will retain your personal information for as long as necessary to fulfill the purposes we collected it for, including for the purposes of satisfying any legal, accounting, or reporting requirements.
To determine the appropriate retention period for personal information, we consider the amount, nature, and sensitivity of the personal information, the potential risk of harm from unauthorized use or disclosure of your personal information, the purposes for which we process your personal information and whether we can achieve those purposes through other means, and the applicable legal requirements.
In some circumstances we may anonymize your personal information (so that it can no longer be associated with you) for research or statistical purposes in which case we may use this information indefinitely without further notice to you. There may also be circumstances where data is retained until it is manually deleted by Ocular Therapeutix.
We have put in place security measures to prevent your personal information from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed while it is under our control. In addition, we limit access to your personal information to those employees, agents, contractors and other third parties who have a business need to know. They will only process your personal information on our instructions and they are subject to a duty of confidentiality.
Please note, however, that any information you send to Ocular Therapeutix via email, in a sign-up form or via the Internet may not be completely secure. We take reasonable steps to protect the personal information provided from loss, misuse and unauthorized access or disclosure. Due to the nature of the Internet, there is a possibility that unsecured (unencrypted) email or Internet transmissions could be
intercepted and read by third parties. Therefore, you should take special care in deciding what information you send to us via e-mail, in a sign-up form or via other Internet transmission.
We may share your personal information with the parties set forth in this section for the purposes described in “How Does Ocular Therapeutix Use Personal Information” above.
We do not allow our third-party service providers to use your personal information for their own purposes and only permit them to process your personal information for specified purposes and in accordance with our instructions.
We do not sell your personal information.
We strive to provide you with choices regarding certain personal information uses, particularly around marketing communications. We may use your Identity Data, Contact Data, Technical Data, Usage Data and Profile Data to form a view on what we think you may want or need, or what may be of interest to you. This is how we decide which services and materials may be relevant for you (we call this marketing). We have established the following personal information control mechanisms:
Online Analytics. We may use third-party web analytics services (such as those of Google Analytics) on our websites to collect and analyze the information discussed above, and to engage in auditing, research or reporting. The information (including your IP address) collected by various analytics technologies described in “Cookies and Other Tracking Mechanisms” below will be disclosed to or collected directly by these service providers, who evaluate information, including by noting the third-party website from which you arrive, analyzing usage trends, assisting with fraud prevention, and providing certain features to you. To prevent Google Analytics from using your information for analytics, you may install the Google Analytics Opt-out Browser Add-on by visiting http://tools.google.com/dlpage/gaoptout.
We may also collect data about your use of our websites through the use of Internet server logs, cookies, tracking pixels, and/or other tracking technologies. As we adopt additional technologies, we may also gather additional information through other methods.
Cookies are small files that are automatically stored on your computer when you visit a website. Cookies are used to (a) recognize your device; (b) store your preferences and settings; (c) understand the web pages of the website you have visited; (d) perform searches and analytics; and (e) assist with security functions. Cookies perform many functions, such as allowing you to navigate between pages efficiently, remembering your preferences, and generally improving the user experience.
A web server log is a file where website activity is stored. An IP address is a number assigned to your device whenever you access the Internet that allows devices and servers to recognize and communicate with each other. Ocular Therapeutix may collect IP addresses to conduct system administration and report aggregate information to affiliates, business partners, service providers and/or vendors to conduct website and application analysis and performance reviews.
Web beacons are small strings of code that are placed in websites, email messages, and/or online ads. They are sometimes called “clear GIFs” (Graphics Interchange Format), “GIF tags”, “Action tags”, “tracking pixels” or “pixel tags.” Web beacons are most often used in conjunction with cookies to track activity on our websites. When you visit a particular web page, web beacons notify us of your visit and for other related website statistics. Since web beacons are used in combination with cookies, if you disable cookies the web beacons will only detect an anonymous website visit. When used in an email, web beacons enable us to know whether you have received or opened the email and may be used for other analytics, personalization, and advertising. Web beacons, cookies and other tracking technologies do not automatically obtain your personal information. Only if you voluntarily submit personal information, such as by registering or sending e-mails, can these automatic tracking technologies be used to provide further information about your use of websites to improve their usefulness to you.
If you do not wish to have cookies on your system, you can set your browser preferences to refuse them or to alert you when cookies are being sent. Please note that you can change your settings to notify you when a cookie is being set or updated, or to block cookies altogether. For additional information, please consult your browser’s “help” section. If you choose to decline cookies, you may not be able to fully experience the features of our websites.
WHAT ABOUT PRIVACY ON OTHER SITES?
Our websites may contain links to other websites that are not owned, controlled, reviewed or monitored by Ocular Therapeutix. Please be aware that we are not responsible for the privacy policies of such other sites or how these sites operate or treat your personal information. We encourage you to be aware that when you leave our websites and to read the privacy policies and terms and conditions of each and every third-party website.
Ocular Therapeutix may require you to provide certain personal information in order for you to, for example, receive additional product information or information about a disease state. You could decide not to submit any personal information at all by not entering it into any forms or data fields and not using any available personalized services.
If you have filled out a form that stores data within our database and wish for the data to be anonymized or removed or believe the personal information we have collected is out of date or incorrect, you may contact us as provided in the “How to Contact Ocular Therapeutix” section below.
If you opt-in for particular services or communications, such as an e-newsletter, you will be able to unsubscribe at any time by following the instructions included in each communication. If you decide to unsubscribe from a service or communication, we will work to remove your information promptly, although we may require additional information before we can process your request. You may also contact us as provided in the “How to Contact Ocular Therapeutix” section below.
Ocular Therapeutix will not discriminate against users that choose to withhold their personal information from us.
While in some instances we may collect personal information about children with the consent of a parent or guardian, such as clinical activities or for patient support programs, we do not otherwise knowingly solicit data from, or market to, children. If a parent or guardian becomes aware that his or her child has provided us with personal information, he or she should contact us as described in the “How to Contact Ocular Therapeutix” section below. We will take reasonable steps to delete such data from our database within a reasonable time.
We do not knowingly collect personal information from children under the age of 13 on our websites. If we become aware that we have collected personal information from children under the age of 13 on our websites, we will take reasonable steps to delete it as soon as practicable. If you think that we have collected personal information from a child under the age of 13, contact us as described in the “How to Contact Ocular Therapeutix” section below.
Some web browsers may transmit “do-not-track” signals to websites with which the browser
If you reside in California, please read this section for additional disclosures about how we collect, use, and disclose information about you and information about your rights under California law.
California Consumer Privacy Act of 2018 (“CCPA”) Supplemental Notice
Information We Collect About You
We collect information that identifies, relates to, describes, references, is reasonably capable of being associated with, or could be reasonably linked, directly or indirectly, with particular California consumers or households (“personal information” as defined by the CCPA and referenced within this CCPA Supplemental Notice). Personal information does not include: (1) publicly available information from government records; (2) de-identified or aggregated consumer information; or (3) information excluded from the CCPA’s scope such as (i) health or medical information collected by entities directly subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (CMIA), clinical trial data, or certain other research data; and
(ii) personal information covered by certain sector-specific privacy laws, including the Fair Credit Reporting Act (FRCA), the Gramm-Leach-Bliley Act (GLBA) or California Financial Information Privacy Act (FIPA), and the Driver’s Privacy Protection Act of 1994.
In particular, we may have collected the following categories of personal information from you within the last twelve (12) months:
Sources of Personal Information
We obtain the personal information from the following categories of sources:
• Directly from you, your caregiver or agent;
Use of Personal Information
We may use the personal information we collect for one or more of the business purposes described above in the “How Does Ocular Therapeutix Use Personal Information” section above.
How We Share Your Personal Information
We do not “sell” (as such term is defined by the CCPA) your personal information.
For information about how we may share your personal information for business purposes, please see the “How Does Ocular Therapeutix Share Personal Information” section above.
How Long We Retain Your Personal Information
For information about how long we may retain your personal information, please see the “How Long Does Ocular Therapeutix Retain Personal Information” section above.
CCPA Rights of California Residents
If you are a California resident, subject to some limitations and the verification of your identity, you have the following rights under the CCPA:
You may designate an authorized agent to exercise your CCPA rights on your behalf in accordance with the CCPA. We may require that you provide the authorized agent with written permission to act on your behalf and that the authorized agent verify his or her identity directly with us.
We do not charge a fee to process or respond to your verifiable request unless it is excessive, repetitive or manifestly unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request. When you submit a request to exercise your CCPA rights, we will do our best to respond to your request as soon as possible after we verify your identity, and, in any event, no later than 45 days after receiving your request.
NOTICE TO NEVADA RESIDENTS
Section 603A of the Nevada Revised Statutes permits Nevada residents who are Ocular Therapeutix “consumers” to at any time, submit a request to an “operator” of a website in Nevada directing the operator not to make any sale of any “covered information” the operator has collected or will collect about the consumer. We do not currently “sell” or plan to sell covered information as defined in the Nevada law. If you are a Nevada resident, you may submit a verified request by contacting us by sending an email to email@example.com or calling 877-628-8998 to opt out of sales and we will record your instructions and incorporate them in the future if our policy changes. We will respond within the time required by law.
HOW TO CONTACT OCULAR THERAPEUTIX
Ocular Therapeutix, Inc.
24 Crosby Drive
Bedford, MA 01730 Attn: Law Department
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