Press Room

Press Release / Mar 17, 2021

Hovione completes its Phase 2 clinical trial of the first minocycline ophthalmic

Showing promise in Dry Eye Disease associated with Inflamed Meibomian Gland Dysfunction

Minocycline Ophthalmic | Hovione

Cork, Ireland, 17 March 2021 – Hovione announced at the Ophthalmology Innovation Summit (OIS) Dry Eye Showcase the successful completion of its Phase 2 clinical trial in 270 patients with Dry Eye caused by Meibomian Gland Dysfunction (MGD). The well controlled and representative study was conducted across 26 clinical sites in the United States and tested 2 different strengths of minocycline against vehicle in a 1:1:1 randomization. This is the first dry eye therapy targeting MGD patients with ocular inflammation demonstrated by an MMP-9 based diagnostic and the first and only ophthalmic formulation of minocycline in clinical development, contingently named Meizuvo®.

The study observed superior clinical outcome in the 70% of patients with positive inflammatory biomarker at baseline, who achieved statistically significant (p=0.02) improvement of 25 points in the Visual Analogue Scale (VAS) discomfort after 2 weeks of treatment, dropping further to 35 points by the end of treatment (an improvement greater than 50%). The sign endpoint inferior Cornea Fluorescein Staining, which is a measure of corneal damage in dry eye, had a statistically significant improvement against vehicle in both active arms at day 57 (p=0.009). The product was safe and well tolerated with less than 3% of subjects reporting blurring vision or eye irritation.

Carla Vozone, Vice President of the innovative proprietary portfolio at Hovione commented: “The correlation between the patients with a positive MMP-9 assay at baseline and the clinical improvement observed in both signs and symptoms of dry-eye was groundbreaking”. Ms. Vozone explained that investigational Meizuvo® not only has the potential of adding a much needed treatment specific for assay recognized inflammation, but could also reduce the risk of failure in the pivotal studies by inclusion of the patient sub-set most responsive to the drug. OIS panelists, who shared their Clinical Perspectives, consensually identified chronic inflammation as the underlying cause of Dry Eye Disease highlighting the relevance of diagnostics to recognize such inflammation.

George Magrath, M.D., CEO of Lexitas Pharma Services stated “We were thrilled with the opportunity to work on this exciting project.  Minocycline is a well-known molecule for ophthalmologists and there is significant excitement from the ophthalmology community regarding the potential for a topical alternative. The results in the overall population were encouraging in both signs and symptoms.  The results in the inflamed group of subjects were impressive with consistent statistically significant results in key dry eye signs and symptoms.”

 

About Minocycline Ophthalmic

Meizuvo® (contingent brand name), is the first minocycline repurposed for ophthalmic administration, targeting a novel indication for inflamed MGD. It is a preservative-free formulation enabled by Hovione’s proprietary minocycline base which is stabilized as a microparticle in a novel vehicle. The highly tolerable formulation maximizes bioavailability, efficacy and reduces systemic effects. Tetracyclines have been known to treat MGD through anti-inflammatory activity and inhibition of matrix metalloproteinases (MMPs). Minocycline is of particular interest due to its lipophilic nature and resultant affinity to the meibomian gland. Previous research also suggests lipase inhibition effect, which decreases meibomian gland lipid degradation and consequently avoids the release of fatty acids, a synergistic mechanism of downregulating the inflammatory process. As such, minocycline has the potential to address several of the mechanisms that lead to the chronic nature of MGD.

 

About Inflamed Meibomian Gland Dysfunction

MGD is a highly prevalent, chronic condition in the eyelid glands which alters the lipid composition of the tears and triggers evaporation-induced tear hyperosmolarity. Evaporative Dry Eye, which affects 27 million people in the USA, constitutes approximately 80% of all Dry Eye Disease and is largely caused by MGD. The pathophysiological changes of the meibomian gland and tear film instability trigger an inflammatory cascade which results in increased matrix metalloproteinase (MMP-9). Left untreated, the MMP-9 activity in the tear will disrupt the corneal epithelial barrier and induce damage of the ocular surface causing ocular irritation and visual morbidity in dry eye patients.

Hovione’s presentation made by Courtney Smith, Director of Business Development & Licensing is accessible here

 

 

About Hovione

Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers, the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.

 

 

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Lisbon, May 21, 2024 – Hovione has placed fourth among the best companies to work in Portugal and was again the best in the Health Sector according to Randstad´s Employer Brand Research. The research, which was published yesterday, identified the 20 best employers in Portugal. This is the ninth annual edition of Ranstad´s study, which is based on a representative sample of the Portuguese workforce. The respondents evaluate companies according to a range of different criteria, including salary and benefits, job security, work atmosphere, and career progression opportunities. Employer branding can have a significant impact on an organization's ability to attract and retain top talent and so is becoming an increasingly important part of a company a strategy to address the talent shortage challenge.  Ilda Ventura, VP of Human Resources at Hovione explains that “Our global HR strategy is built on the need to attract, retain and empower our talented team members. Therefore, our Employer Branding needs to reflect the reality of who we are, so that we don’t just attract new talent but allow current team members to flourish. It also needs to capture the positive impact that Hovione has on the world, and how our innovative work relies on the knowledge and problem solving of our team members. We continue to work on refining and improving the work we do on our EB. This too is an important reflection of our values, and our belief in continuous improvement.” This is the third successive year that has been ranked as the most attractive company to work for in the Health Sector and placed in the top five overall  This recognition comes after Hovione was recognized as a Top Employer in all four of its global sites in January 2024, becoming the first company in Macau to do so.    About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.     Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.  

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The newly formed company will focus on developing innovative technologies and scalable solutions to help pharmaceutical companies address formulation and manufacturing challenges in transformative cell and gene therapies. Hovione has a strong track record in industrializing new technologies and supporting Pharma Companies with their clinical and commercial volume manufacturing needs, while iBET has a strong biological background and a global reputation for its scientific knowledge of the new therapeutic modalities space, particularly cell and gene therapy.  New modalities, such as gene and cell therapies, RNA drugs and other complex biologics, are a rapidly growing segment of the pharmaceutical industry. They promise to bring breakthroughs to the treatment of a wide range of diseases and conditions, including cancer, genetic disorders, rare diseases and neurological conditions.  While this rapid growth has been driven by remarkable efficacy in addressing unmet clinical needs, the complex nature of the new modalities brings challenges, including limited drug administration options, immunogenic responses and off-target effects, issues with high dose delivery and high costs. The poor stability of these drugs is also an issue, resulting in the need for cold supply chains. ViSync will aim to develop novel technology platforms to address the unmet needs of pharmaceutical customers developing these transformative new products. “The creation of ViSync in collaboration with iBET marks an exciting new chapter in Hovione´s commitment to innovation”, said Dr Jean-Luc Herbeaux, Hovione´s CEO. “New therapeutic modalities have the potential to bring radical improvements to current standards of care and we are thrilled to partner with iBET, a world-renowned expert organization in this area, to develop technology platforms that help customers bring transformative therapies to patients worldwide. The first step will be to assemble a team who possesses the knowledge, expertise, and ingenuity needed to navigate the complexities ahead." “The establishment of ViSync in partnership with Hovione represents a pivotal moment in iBET’s dedication to pioneering research in advanced therapies,” stated Dr. Paula Alves, iBET’s CEO. “The immense promise of these new modalities is at our reach and we are delighted to join forces with Hovione, a globally recognized leader in technological industrialization and drug delivery. In this common endeavor, we will gather the scientific and technical competences and skills to support our clients and partners in delivering groundbreaking therapies to patients globally.” ViSync will develop its own lab facility in Lisbon and expects to be able to start its research and development work by the end of 2024.   About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.     Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.   About iBET iBET is a private non-profit institution devoted to biotechnology research, with 35 years of experience creating and transferring knowledge to the global biopharma and biotech sectors. iBET’s core expertise lies on the development of bioprocessses and analytical tools for Advanced Therapeutic Medicinal Products (ATMPs), including cell and gene therapies, vaccines, antibodies and other innovative therapeutic products. Leveraged by the emerging areas of Data Science and Translational Immunology, we offer bespoke R&D services from early-stage R&D to GMP manufacturing.  iBET’s infrastructure comprises cutting-edge laboratories, a GMP certified Analytical Services Unit, and a Late-Stage R&D and Bioproduction Unit, covering upstream and downstream process development, bioanalytical tools for critical quality attribute monitoring, to scale-up and tech transfer. iBET also hosts satellite laboratories of major pharmaceutical companies and serves as an incubation platform for start-up/spin-off companies. iBET is driven by its innovative and agile culture of continuous improvement and a strong sense of ambition, ownership and commitment in developing and delivering the best solutions to our stakeholders.  

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