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Privacy Policy

This Privacy Policy (the “Policy”) describes the types of information Dompé U.S. and its subsidiaries and affiliated companies (“Dompé”) collect from and about you when you visit our website, www.oxervate.com (“Site”). This Policy also explains how Dompé may use and disclose such information, as well as your ability to control certain uses of it.

By using the Site, you agree to the collection, use, and disclosure of your information as described in this Policy. If you do not agree, please do not access or use the Site.

QUICK GUIDE TO CONTENTS
  1. INFORMATION WE COLLECT
    1. Information You Provide
    2. Information Automatically Collected
    3. Information Collected From Other Sources
    4. Combination of Information
  2. OUR INFORMATION USE
    1. Use by or for Dompé
    2. How We Use Your Information for Interest-Based Advertising
  3. INFORMATION WE SHARE WITH OTHERS
  4. YOUR CHOICES AND OPT-OUTS
    1. Cookies, Tracking Options, and California Do Not Track Disclosures
    2. Interest-Based Advertising Choices
    3. Unsubscribing From Our Marketing Communications
    4. Updating Your Information
  5. YOUR CALIFORNIA PRIVACY RIGHTS
  6. THIRD-PARTY CONTENT AND LINKS
  7. CHILDREN'S PRIVACY
  8. DATA SECURITY
  9. DATA STORAGE
  10. REVISIONS TO THIS PRIVACY POLICY
  11. HOW TO CONTACT US

1. INFORMATION WE COLLECT

There are several ways we may obtain information about you, including through (A) information you provide to us directly; (B) information that we automatically collect; and (C) information we receive from third parties. This includes data that identifies you personally whether directly (i.e., your name) or indirectly (i.e., information about your online use).

A. Information You Provide

Dompé collects information from you when you choose to share it with us through the Site. This may include when you use our Site, register online through the Site, request information from us, sign up for our email list, request customer support, or otherwise communicate with or contact us. The information we collect may include your first and last name, your organization name, and your email.

B. Information Automatically Collected

Whenever you visit or interact with the Site, we, as well as any of our third-party service providers, may use a variety of technologies such as cookies, web beacons, pixel tags, log files, local shared objects (Flash cookies), HTML5 cookies, or other technologies to automatically or passively collect certain information about your online activity.

Please note that we may automatically collect the following information about you:

  • Computer or Device Information. We may automatically collect your Internet Protocol (“IP”) address or other unique identifier or information from the computer, mobile device, tablet or other device that you use to access the Site, including but not limited to your browser type, device type, operating system, software version, phone model, phone operating system, and the domain name from which you accessed the Site.
  • Usage Information. We may collect information about your use of the Site, including the date and time you visit the Site, the areas or pages of the Site that you visit, the amount of time you spend viewing or using the Site, the number of times you return to the Site, other click-stream or site usage data, emails that you open, forward or click-through to our Site, and other sites that you may visit.
  • Location Information. We collect general information about where traffic on our site is coming from around the world. This is used at an aggregate level that does not identify individual users to create reports to better understand our engagement with visitors to the site. Location information at an individual level may be used for narrowly tailored efforts for our products or research activities.
  • Our Third-Party Service Providers. We may use third-party service providers to support our Site. Some of these service providers may use technology such as cookies, web beacons, pixel tags, log files, Flash cookies, or HTML5 cookies to receive, collect, and store information.
  • Use of Third-Party Analytic Technologies. We may use third parties’ analytics and tracking tools, including Google Analytics, to better understand who is using the Site, how people are using the Site, and how to improve the effectiveness of the Site and related content. These tools may use technology such as cookies, web beacons, pixel tags, log files, Flash cookies, HTML5 cookies, or other technologies to automatically collect and store certain information. They may also combine information they collect from your interaction with the Site with information they collect from other sources. We do not have access to, or control over, these third parties’ use of cookies or other tracking technologies.

C. Information Collected From Other Sources

We may acquire information from other sources as follows:

  • From other trusted third-party sources to update or supplement the information that you provide or that we collect automatically. This includes, for example, information from public databases or data aggregators (which may include information to validate or update the information we collect from or about you).
  • From our partners and service providers (including, for example, business partners, analytics vendors, and search information providers).

We may use this information to help us maintain the accuracy of the information we collect, target our communications so that we can inform you of products, services or other offers that may be of interest to you, and for internal business analysis or other business purposes.

D. Combination of Information

We may combine the information we receive from and about you, including information you provide to us and information we automatically collect through our Site, as well as information collected offline, and from third-party sources.

2. OUR INFORMATION USE

A. Use by or for Dompé

Dompé may use the information we collect from and about you for any of the following purposes:

  • To respond to your inquiries and contact and communicate with you when necessary;
  • To review the usage and operations of our Site and conduct analysis to enhance or improve our content, products, and services;
  • To provide you with advertising on the Site, via mail or email, or across other websites, mobile applications, social media, or online services;
  • To contact you, including by mail or email, with information, newsletters, and promotional materials from Dompé or on behalf of our affiliates, and to request information from you relating to your use of our products and services;
  • To use your data in an aggregated non-specific format for analytical and demographic purposes;
  • To address problems with the Site or our business, and to protect the security or integrity of the Site and our business;
  • For other purposes disclosed at the time you provide your information or otherwise with your consent.

B. How We Use Your Information for Interest-Based Advertising

We may use third parties to measure and target advertisements for us about our products and services that are tailored to your online interests. We allow these third-party companies to use cookies, web beacons, pixel tags, and similar technologies to collect certain data and other information about your online activity. This information is used to display advertisements for Dompé on the Site or across other websites that you visit.

For information on your choices with respect to interest-based ads, see the “Interest-Based Advertising Choices” section below.

3. INFORMATION WE SHARE WITH OTHERS

Except as provided in this Policy, we will not disclose, sell, or rent any of your information to any third parties without your consent. We may share the information we collect from and about you with the following:

  • Affiliates: We may share your information with Dompé affiliates and subsidiaries bearing the Dompé brand for business, operational, promotional, and marketing purposes.
  • Service Providers: We may share your information with third-party service providers (including Dompé farmaceutici S.p.A. for market access activities management) that provide business, professional, or technical support functions for us, help us operate our business and the Site, or administer activities on our behalf.
  • Legal Matters; Safety: We may access and disclose your information to respond to subpoenas, judicial processes, or government requests and investigations, or in connection with an investigation on matters related to public safety, as permitted by law, or otherwise as required by law. We may disclose your information to protect the security of our Site, servers, network systems, and databases. We also may disclose your information as necessary, if we believe that there has been a violation of a legal document or contract related to our services, or the rights of any third party.
  • Sale or Transfer of Business or Assets: We may sell or purchase assets during the normal course of our business. If another entity acquires us or any of our assets, information we have collected about you may be transferred to such entity. In addition, if any bankruptcy or reorganization proceeding is brought by or against us, such information may be considered an asset of ours and may be sold or transferred to third parties. Should such a sale or transfer occur, we will use reasonable efforts to try to require that the transferee use personal information provided through this Site in a manner that is consistent with this Privacy Policy.
  • Aggregate or Anonymous Non-Personal Information: We may also share aggregate, anonymous, or de-identified non-personal information with third parties for their marketing or analytics uses.
  • Sharing Your Information With the Headquarters – Information According to the EU GDPR: As part of our sharing of information within the Dompé group we may share your personal information with Dompé farmaceutici S.p.A. in Italy, that will process the information for administrative and organizational purposes, as data controller (as defined under art. 4 of the EU General Data Protection Regulation n. 2016/679, "GDPR"), in order to coordinate and supervise the activity carried out by its subsidiaries, including Dompé US. Dompé farmaceutici S.p.A. will act in compliance with the obligations set forth under the GDPR. The processing will be carried out based on the legitimate interest of Dompé farmaceutici S.P.A. of management and control activities of the Dompé group in its role of headquarter.

    The GDPR gives you certain privacy rights which include: the right to request access to your information at any time; the right to request correction of your information; the right to object to processing of your information; the right to restrict processing of your information and to request erasure; the right to request transferring some of your information to other organizations. To exercise your privacy rights please contact privacy@dompe.com or by mail at Via San Martino 12/12a, Milan. The Data Protection Officer may be contacted by email at DPO@dompe.com.
  • Other: We also may share your information as disclosed to you at the time of collection.

4. YOUR CHOICES AND OPT-OUTS

A. Cookies, Tracking Options, and California Do Not Track Disclosures

Certain parts of our Site require cookies. You may adjust your device or Internet browser settings to limit certain tracking or to decline cookies, but by doing so, you may not be able to use certain features of the Site or take full advantage of all of our offerings. Please refer to your device’s settings or your Internet browser’s “Help” section for more information on how to delete and/or disable your device or browser from receiving cookies or controlling your tracking preferences.

Our system may not recognize Do Not Track requests or headers from some or all browsers. We may use cookies or other technologies to deliver advertising for our products when you visit other websites.

B. Interest-Based Advertising Choices

To understand your choices for receiving more relevant advertising provided on other websites and online services, please review the information below:

  • To learn more about such interest-based advertising, and to opt out of such collection and use for interest-based advertising by the Digital Advertising Alliance (DAA) participating companies, please visit http://optout.aboutads.info.
  • To opt out from the use of information about your online activities for interest-based advertising by Network Advertising Initiative (NAI) member companies, please visit http://optout.networkadvertising.org.
  • If you wish to prevent your data from being used by Google Analytics, Google has developed the Google Analytics opt-out browser add-on available https://tools.google.com/dlpage/gaoptout/.
  • On your mobile device, you may also adjust your privacy and advertising settings to control whether you want to receive more relevant advertising.

Even if you opt out, you still may receive advertising from us that is not customized based on your Service or usage information, or advertising from other third parties if they are not a DAA or NAI participating company.

C. Unsubscribing From Our Marketing Communications

We provide our Site visitors with the opportunity to update their information or opt out of having their information used for purposes not directly related to placement, processing, fulfillment, or delivery of a product order or servicing of your product or request. To opt out of marketing communications, you may:

  • Send us an email at unsubscribe-oxervate@dompe.com;
  • Contact us by mail at the address below in the “Contact Us” section, or
  • Unsubscribe from our email communications at any time by clicking here.

If you receive marketing communications from one or more Dompé affiliates, you must opt out individually from each of the affiliates from which you are receiving brand-specific marketing communications.

Your instructions to limit the use of your information for these purposes will be processed as soon as reasonably practicable. Additionally, we are not responsible for informing third parties (including without limitation our third-party service providers or partners) with whom we have already shared your personal information of any changes requested pursuant to this section, or for removing information from or causing information to be removed from the databases or records of such entities.

D. Updating Your Information

If you wish to update any of your personal information, you may contact us at the address or email in the “Contact Us” section below.

5. YOUR CALIFORNIA PRIVACY RIGHTS

Dompé shares personal information between Dompé affiliates and marketing agents for marketing purposes. We do not share your personal information with unaffiliated third parties for their own independent marketing purposes without your consent. California residents may request the categories of personal information Dompé shared with third parties for the third parties' direct marketing purposes during the previous calendar year, if any. To make your request, send an email to privacy@dompe.com. Written requests may be sent to:

Dompé U.S.
Attn: Privacy Officer
One Marina Park Dr., Suite 1410
Boston, MA 02210

You must put the statement “Your California Privacy Rights” in the subject field. We are not responsible for notices that are not labeled or sent properly, or do not have complete information.

6. THIRD-PARTY CONTENT AND LINKS

The Site may have links to third-party websites, which may have privacy policies that differ from our own. We are not responsible for the practices of such sites.

7. CHILDREN’S PRIVACY

Protecting children’s privacy is important to us. We do not direct the Site to, nor do we knowingly collect any personal information from, children under the age of thirteen. If Dompé learns that a child under the age of thirteen has provided personally identifiable information to the Site, it will use reasonable efforts to remove such information from its files.

8. DATA SECURITY

We have taken certain physical, administrative, and technical steps to safeguard the information we collect from and about our customers and Site visitors. While we make every effort to help ensure the integrity and security of our network and systems, we cannot guarantee our security measures.

9. DATA STORAGE

Your personal information is stored on servers in the United States; however, some of our brands, subsidiaries, parent company, and Service Providers may store information on servers hosted in other countries. As such, your personal information may be subject to the laws of other countries, where the data protection and other laws may differ from those of the United States. Your personal information may be disclosed in response to inquiries or requests from government authorities or to respond to judicial process in the countries in which we operate.

10. REVISIONS TO THIS PRIVACY POLICY

We reserve the right, at our sole discretion, to change, modify, add, remove, or otherwise revise portions of this Policy at any time. When we do, we will post the change(s) on the Site. Your continued use of the Site following the posting of changes to these terms means you accept these changes. If we change the Privacy Policy in a material way, we will provide appropriate notice to you.

11. HOW TO CONTACT US

If you have any questions or concerns about this Policy or the practices described herein, you may contact us at privacy@dompe.com or by mail to:

Dompé U.S.
Attn: Privacy Officer
One Marina Park Dr., Suite 1410
Boston, MA 02210

Important Safety Information

The most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients.

Important Safety Information

MORE LESS

The most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients.

WHAT IS OXERVATE™?

OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.

DOSAGE FORMS AND STRENGTHS

Ophthalmic solution for topical use in the eye: cenegermin-bkbj 0.002% (20 mcg/mL) is a clear, colorless solution in a multiple-dose vial.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Use With Contact Lenses

Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

Eye Discomfort

OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

ADVERSE REACTIONS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be compared directly to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In 2 clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks. The mean age of the population was 61 to 65 years of age (18 to 95).

The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Other adverse reactions included corneal deposits, foreign body sensation in the eye, ocular hyperemia (enlarged blood vessels in the white of the eye), swelling (inflammation) of the eye, and increase in tears (1%-10% of patients).

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

There are no data from the use of OXERVATE in pregnant women to inform any drug-associated risks.

Administration of cenegermin-bkbj to pregnant rats or rabbits during the period of organogenesis did not produce adverse fetal effects at clinically relevant doses. In a pre- and postnatal development study, administration of cenegermin-bkbj to pregnant rats throughout gestation and lactation did not produce adverse effects in offspring at clinically relevant doses.

Data

Animal Data

In embryofetal development studies, daily subcutaneous administration of cenegermin-bkbj to pregnant rats and rabbits throughout the period of organogenesis produced a slight increase in postimplantation loss at doses greater than or equal to 42 mcg/kg/day (267 times the maximum recommended human ophthalmic dose [MRHOD]). A no-observed-adverse-effect level (NOAEL) was not established for postimplantation loss in either species. In rats, hydrocephaly and ureter anomalies were observed once each in fetuses at 267 mcg/kg/day (1709 times the MRHOD). In rabbits, cardiovascular malformations, including ventricular and atrial septal defects, enlarged heart, and aortic arch dilation, were observed once each in fetuses at 83 mcg/kg/day (534 times the MRHOD). No fetal malformations were observed in rats and rabbits at doses of 133 mcg/kg/day and 42 mcg/kg/day, respectively.

In a pre- and postnatal development study, daily subcutaneous administration of cenegermin-bkbj to pregnant rats during the period of organogenesis and lactation did not affect parturition and was not associated with adverse toxicity in offspring at doses up to 267 mcg/kg/day.

In parental rats and rabbits, an immunogenic response to cenegermin-bkbj was observed. Given that cenegermin-bkbj is a heterologous protein in animals, this response may not be relevant to humans.

Lactation

Risk Summary

There are no data on the presence of OXERVATE in human milk, the effects on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OXERVATE and with any potential adverse effects on the breastfed infant.

Pediatric Use

The safety and effectiveness of OXERVATE have been established in the pediatric population. Use of OXERVATE in this population is supported by evidence from adequate and well-controlled trials of OXERVATE in adults with additional safety data in pediatric patients from 2 years of age and older.

Geriatric Use

Of the total number of subjects in clinical studies of OXERVATE, 43.5% were 65 years old and older. No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

Important Safety Information

MORE LESS

The most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients.

WHAT IS OXERVATE™?

OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.

DOSAGE FORMS AND STRENGTHS

Ophthalmic solution for topical use in the eye: cenegermin-bkbj 0.002% (20 mcg/mL) is a clear, colorless solution in a multiple-dose vial.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Use With Contact Lenses

Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

Eye Discomfort

OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

ADVERSE REACTIONS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be compared directly to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In 2 clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks. The mean age of the population was 61 to 65 years of age (18 to 95).

The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Other adverse reactions included corneal deposits, foreign body sensation in the eye, ocular hyperemia (enlarged blood vessels in the white of the eye), swelling (inflammation) of the eye, and increase in tears (1%-10% of patients).

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

There are no data from the use of OXERVATE in pregnant women to inform any drug-associated risks.

Administration of cenegermin-bkbj to pregnant rats or rabbits during the period of organogenesis did not produce adverse fetal effects at clinically relevant doses. In a pre- and postnatal development study, administration of cenegermin-bkbj to pregnant rats throughout gestation and lactation did not produce adverse effects in offspring at clinically relevant doses.

Data

Animal Data

In embryofetal development studies, daily subcutaneous administration of cenegermin-bkbj to pregnant rats and rabbits throughout the period of organogenesis produced a slight increase in postimplantation loss at doses greater than or equal to 42 mcg/kg/day (267 times the maximum recommended human ophthalmic dose [MRHOD]). A no-observed-adverse-effect level (NOAEL) was not established for postimplantation loss in either species. In rats, hydrocephaly and ureter anomalies were observed once each in fetuses at 267 mcg/kg/day (1709 times the MRHOD). In rabbits, cardiovascular malformations, including ventricular and atrial septal defects, enlarged heart, and aortic arch dilation, were observed once each in fetuses at 83 mcg/kg/day (534 times the MRHOD). No fetal malformations were observed in rats and rabbits at doses of 133 mcg/kg/day and 42 mcg/kg/day, respectively.

In a pre- and postnatal development study, daily subcutaneous administration of cenegermin-bkbj to pregnant rats during the period of organogenesis and lactation did not affect parturition and was not associated with adverse toxicity in offspring at doses up to 267 mcg/kg/day.

In parental rats and rabbits, an immunogenic response to cenegermin-bkbj was observed. Given that cenegermin-bkbj is a heterologous protein in animals, this response may not be relevant to humans.

Lactation

Risk Summary

There are no data on the presence of OXERVATE in human milk, the effects on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OXERVATE and with any potential adverse effects on the breastfed infant.

Pediatric Use

The safety and effectiveness of OXERVATE have been established in the pediatric population. Use of OXERVATE in this population is supported by evidence from adequate and well-controlled trials of OXERVATE in adults with additional safety data in pediatric patients from 2 years of age and older.

Geriatric Use

Of the total number of subjects in clinical studies of OXERVATE, 43.5% were 65 years old and older. No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

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