Laboratorios Salvat strengthens its commitment to those affected by glaucoma by meeting their specific needs

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  • The pharmaceutical company and the Glaucoma Association for People Affected and Families (AGAF) in collaboration and endorsed by the Spanish Glaucoma Society will publish the book ‘The 101 doubts about Glaucoma that you always wanted to know and did not dare to ask’.
  • The laboratory thus reaffirms its presence in the field of ophthalmology to benefit families, professionals and patients involved in the management of the disease.
  • Around 60 million people worldwide suffer from this eye ailment. 7.8 million of these cases are Europe-based, with a prevalence of 2.51% in the continent.

    • Salvat, an international pharmaceutical laboratory, reaffirms its presence and commitment in the field of ophthalmology to benefit families, professionals and patients involved in the treatment of glaucoma. On the occasion of the International Day of this disease, the pharmaceutical company announces the forthcoming publication of the book ‘The 101 doubts about Glaucoma that you always wanted to know and did not dare to ask’ in collaboration with the Glaucoma Association for People Affected and Relatives (AGAF) and the Spanish Glaucoma Society (SEG). Thus, both are committed to offering more effective support by identifying the specific needs of people suffering from Glaucoma.

    According to the study ‘Epidemiology of Glaucoma: The Past, Present, and Predictions for the Future’, around 60 million people worldwide are affected by primary open-angle glaucoma (POAG), with 7.8 million of those cases being Europe-based. The prevalence of the disease this continent is of 2.51%. Also, by, 2040, it is expected that more than 110 million around the world will suffer from glaucoma. It has been proven that early detection of it is essential to prevent its effects and treat it appropriately. If not, the condition may progress as a silent disease.

    ‘The 101 doubts about Glaucoma that you always wanted to know and did not dare to ask’ is part of the commitment of Salvat, AGAF and SEG to improve the quality of life of people affected by glaucoma. The book will resolve a whole series of questions of people affected by the disease that, for various reasons, they find difficult to convey to doctors. These questions have been answered thanks to the different health professionals provided by the Spanish Glaucoma Society (SEG), which has also endorsed the content of the texts. The book will have different thematic blocks: daily life, technical information about the disease, treatments and interventions, psychological aspects and improvement of disease control.

    Alberto Bueno, CEO of Laboratorios Salvat, highlights the company’s efforts to assist all those who deal with glaucoma. “As a company operating in the healthcare field, we are very clear that our work must go beyond the development of pharmaceutical products. Both professionals around the world who work on the treatment of Glaucoma and patients suffering from the disease need their necessities to be addressed, which, unfortunately, can go unnoticed. That is why we intend to continue listening to them in order to be able to work on new dissemination materials that can be useful to as many people as possible,” he explains.

    For his part, Joaquín María Carratalá, president of AGAF, stresses the help that the publication represents. “For the Glaucoma Association for Patients and Relatives, this book is the answer to many doubts that patients have raised throughout the 18 years that AGAF has been having. Addressing all these issues, giving explanations from experts and at the forefront of care for people with glaucoma, is a reference for resolving these issues. Glaucoma patients, from the moment they are diagnosed, pose problems that there is not always time to respond to in medical consultations. They also have doubts about issues that are not properly medical. For this reason, in this book we wanted to encompass all these concerns, something that for our association is a very important help when it comes to dealing with the disease. Hence our thanks to all the parties who have made this publication possible together with us.”

    Dr. Francisco J. Muñoz Negrete, president of the SEG , adds: “Due to the enormous burden of care, it is impossible to provide the patient with all the information and resolve all the doubts that arise about glaucoma and its treatment. Thanks to materials such as this manual, it will be possible to prevent those affected by the disease from resorting to incomplete, poorly verified or outright false information found on the web. Having access to science-based answers will undoubtedly improve our understanding of glaucoma. In addition, it will help the patient to improve their lifestyle habits in order to better control the disease.”

Salvat Laboratories initiates a pioneering pediatric study in Europe with its innovative drug SVT-15473, for the treatment of inflammation and pain following ocular surgery

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  • Phase III clinical trials conducted in adults confirm the efficacy and excellent safety profile of SVT-15473 ophthalmic clobetasol, formulated with IMPACT-SVT® patented nanoemulsion technology, for the treatment of inflammation and pain following ocular surgery.

  • This is the first clinical study conducted in Europe in pediatric patients with a topical ophthalmic corticosteroid.

  • With the new study, which is being carried out in six Spanish hospitals, its safety in pediatric patients aged 0 to 3 years is expected to be also demonstrated.

  • With this project, which has involved a total investment of over 20 million euros, Salvat Laboratories takes another step in its strategy to establish itself as a key international player in the field of ophthalmology.

Salvat, an international laboratory that develops, manufactures, and markets products such as Cristalmina®, Gama Relive®, Tebarat®, and Cetraxal® Plus, has initiated a new study with SVT-15473 clobetasol, the first ocular corticosteroid formulated with IMPACT-SVT® patented nanoemulsion technology, to treat inflammation and pain in patients undergoing ocular surgery. In this case, the trial will include children aged 0 to 3 years with cataracts, aiming to demonstrate the drug’s safety in this population as well.

Cataracts in pediatric patients can be congenital or acquired as part of certain diseases. Overall, the incidence of pediatric cataracts ranges from 1 to 5 cases per 10,000 individuals.

The new study, which is the first to be conducted in Europe with topical corticosteroids in this pathology and population, will include 60 cases randomly divided into two equal groups. One group will be treated with SVT-15473, and the other, as a control group, with Prednisolone. The study will take place in six Spanish hospitals, with coordination led by Dr. Marta Morales, Head of the Ophthalmology Department at Hospital Sant Joan de Déu in Barcelona. The participating hospitals include Vall d’Hebron Hospital and Germans Trias i Pujol Hospital, both in Barcelona, La Paz Hospital in Madrid, Cruces Hospital in Bilbao, and Miguel Servet Hospital in Zaragoza. Currently, there are already 4 patients included and treated.

The conduct of this new study was agreed upon with the Food and Drug Administration (FDA), as part of the approval process that has already been initiated, based on the results of clinical trials involving 400 adult patients from 50 hospitals in the United States. These trials demonstrated the effectiveness and safety of SVT-15473 in treating inflammation and ocular pain following cataract surgery.

This new study, which aims to demonstrate the safety of SVT-15473 in patients aged 0 to 3 years, is complementary and does not interfere with the ongoing approval process, which is expected to conclude soon. “Once we have completed this study in the pediatric population, the indication could be expanded to include this age group, allowing the use of SVT-15473 clobetasol in any patient, regardless of their age,” explains Enrique Jiménez, Medical Director of Salvat Laboratories.

Innovation in the Industry

Salvat has developed IMPACT-SVT®, a patented nanoemulsion technology (emulsion with nanometer-sized droplets) for drug administration, promoting its penetration and accelerating the onset of its action, while providing excellent ocular comfort. IMPACT-SVT® has enabled the development of SVT-15473 using clobetasol, a “superpotent” corticosteroid that has never been used in the form of eye drops before.

Manufactured with BFS (Blow-Fill-Seal) technology, a sterile, advanced, and automated single-dose vial manufacturing system, SVT-15473 will be produced in the manufacturing line of Salvat USA Inc. in Miami, Florida, and in Pharmaloop S.L., Salvat’s facility in Alcalá de Henares, Madrid.

With this project, which has involved a total investment of over 20 million euros, Salvat Laboratories takes another step in its strategy to establish itself as a key international player in the field of ophthalmology.

Salvat Laboratories presented Phase III clinical trials results of Clobetasol Nanoemulsion for treating inflammation and pain after ocular surgery at the 2023 ARVO Annual Meeting

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Salvat Laboratories, the international pharmaceutical company focused on the development, manufacturing, and commercialization of ophthalmology treatments, announced the results of phase III clinical trials of its most potent ophthalmic corticosteroid in the global ophthalmology market at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held from 23-27 April 2023 in New Orleans. Studies’ global coordinator, Dr. Andrew Schwartz (Fifth Avenue Eye Associates, NYC), presented a poster outlining the SVT-15473 clobetasol 0.05% ophthalmic nanoemulsion phase III clinical trial results for the treatment of inflammation and pain post-ocular surgery.

The presentation includes the pooled data of two successful phase III clinical trials of clobetasol, which were conducted between 2020 and 2021, testing more than 400 patients in over 40 specialized centers in the United States. The trials demonstrated the efficacy and safety of this innovative approach, with clobetasol proving effective in reducing inflammation and pain in post-ocular surgery patients. Read more about the clinical trials here.

Salvat Laboratories has developed IMPACT-SVT®, a patented nanoemulsion drug delivery technology that improves drug penetration and bio-adhesion, providing excellent comfort. IMPACT-SVT® made it possible to develop SVT-15473 using clobetasol, a “superpotent” corticosteroid that had never been used before as eye drops. In addition to its efficacy and safety, clinical trials have shown that it has very low impact on intraocular pressure, unlike many other corticosteroids.

The exclusive nanoemulsion formulation (emulsion with drops of nanometric size) offers superior advantages over other established alternatives that are readily available, including better coverage of the ocular surface, more effective absorption, and no blurred vision or discomfort after application. After a standard 14-day course of treatment, the therapy has proven to have no rebound effect in the following 2 weeks, hence not requiring a gradual decrease in dosage towards the end of treatment.

Designed with Blow-Fill-Seal technology, an advanced, sterile, and automated single-dose vials manufacturing system, the new drug will be produced on the manufacturing line of Salvat USA Inc. in Miami (Florida), and at Salvat’s manufacturing site Pharmaloop S.L. in Alcala de Henares (Madrid).

The new drug is currently being reviewed by the US Food and Drug Administration (FDA), with approval expected in summer 2023. The submission of the NDA to the FDA is a significant step in the company’s strategy to position itself as one of the main players in the field of ophthalmology worldwide in the coming years.

Salvat Laboratories has invested over 20 million euros into this project, reinforcing its ophthalmology line as one of its main areas of research and development, aiming to improve people’s quality of life through innovation and the development of medicines and healthcare products with high-added value.

Salvat Laboratory submits application to the U.S. FDA for approval of Clotrimazole, a pioneering drug for the treatment of otomycosis

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  • The new drug will be the only one on the market in the United States and Europe specifically formulated and indicated for the topical treatment of fungal otitis externa.
  • Salvat has invested 22 million euros in this project with which reinforces its position as a leading laboratory in the field of otology at an international level.

Salvat, an international pharmaceutical company focused on the development, manufacturing and commercialization through partners worldwide of products such as Otovel and Cetraxal, has submitted the new drug application (NDA) for Clotrimazole to the FDA, the new treatment for fungal otitis externa.

The company thus begins the procedures to launch the new drug in the American market, where it is expected to be available in summer 2023.

For Alberto Bueno, CEO of Salvat, “this project is a reflection of the firm commitment we have made to R+D in the area of otology, and reinforces our leadership position in this therapeutic area, without losing focus on other areas of strategic growth for Salvat”.

Single and cutting-edge drug in otology

Salvat’s Clotrimazole represents a breakthrough in the treatment of this type of otitis externa since it will be the first and only existing drug in the United States and Europe specifically indicated to treat this pathology. While there are other medications or formulations on the market that can help managing the symptoms of this condition, Salvat’s bet is the only one focused on effectively treating otomycosis.

Salvat has specifically formulated Clotrimazole for otic use in the form of single-dose vials, making it easier for patients to use. This format also ensures the sterility of the product and, by containing the necessary amount of active ingredient, also warrants the correct use of the drug.

Years of research with exceptionally good results

The new drug has undergone two demanding clinical trials to evaluate its efficacy and safety. The trials have been conducted over 3 years in more than 400 adult patients affected by otomycosis, from hospitals in the United States, Mexico, and Europe.

Both studies have concluded with very positive results that confirm the efficacy and safety of the new drug for the eradication of the fungus that causes otomycosis and the associated clinical symptoms (pain, itching, feeling of fullness and hearing loss).

Investment and manufacturing

Since 2019, Salvat has invested more than 22 million euros in the development of this formulation of Clotrimazole, whose manufacture will be carried out in the plants of Salvat USA Inc. in Tamarac (Florida) and in the plant of Pharmaloop, S.L. in Alcalá de Henares (Madrid). Both companies are subsidiaries of Laboratorios Salvat S.A.

Salvat, pioneer in Otolaryngology

Salvat is one of the top pharmaceutical companies in developing and commercializing innovative otology products. Also, Salvat is the first to develop and commercialize otic drug products in single-dose vials worldwide. Otolaryngologists recognize Salvat as the number 1 company in the development of treatments for otology. This new drug for the treatment of otomycosis confirms Salvat’s commitment to this medical specialty and the company’s willingness to strengthen its leadership in the treatment of ear diseases.

Salvat Laboratories announces submission of New Drug Application to the U.S. FDA for Clobetasol Nanoemulsion for treating inflammation and pain after ocular surgery

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Salvat Laboratories, the international company which developed and owns the globally commercialized products Otovel and Cetraxal, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in post-ocular surgery patients.

Clinical Trials

This submission comes after two successful phase III clinical trials conducted between 2020 and 2021. This new and pioneering corticosteroid in ophthalmology, clobetasol, was tested in more than 400 patients in the United States in over 40 different specialized centers, demonstrating the efficacy and safety of this innovative approach.

Innovation in the Industry

Salvat has developed IMPACT-SVT®, a patented nanoemulsion drug delivery technology that improves drug penetration and bio-adhesion, providing excellent comfort.

IMPACT-SVT® made it possible to develop SVT-15473 using clobetasol; this “superpotent” corticosteroid has never been used before as eye drops. Its presentation in single-dose vials offers superior advantages over other established alternatives that are readily available. In addition to its efficacy and safety, clinical trials have shown that it has very low impact on intraocular pressure, unlike many other corticosteroids.

After a standard 14-day course of treatment, the therapy has proven to have no rebound effect in the following 2 weeks, hence it doesn’t require a gradual decrease in dosage towards the end of treatment. There is no need to shake the product before use, as the nanoemulsion ensures even drug concentration in every drop. Our exclusive nanoemulsion formulation (emulsion with drops of nanometric size) provides additional comfort to the patient. It also features better coverage of the ocular surface, more effective absorption, and no blurred vision or discomfort after application.

Designed with Blow-Fill-Seal technology, an advanced, sterile, and automated single-dose vials manufacturing system, the new drug will be produced on the manufacturing line of Salvat USA Inc. in Miami (Florida), and at Salvat’s manufacturing site Pharmaloop S.L. in Alcalá de Henares (Madrid).

Significance for Salvat Laboratories

Salvat Laboratories has invested over 20 million euros into this project, and this NDA submission is a big step in its goal of becoming a key player in ophthalmology. This is a great achievement for the company: “I am beyond thrilled to have submitted our FDA application for the future launch of this new corticosteroid. Once authorized, post-ocular surgery patients will see their treatment improve significantly. Additionally, the rest of the projects that are currently underway reinforce our ophthalmology line as one of our main areas of research and development and strengthen the company’s strategy to position itself as one of the main players in the field of ophthalmology worldwide in the coming years,” says Alberto Bueno, Salvat’s CEO.

Salvat, pioneer in using cell-therapy for the treatment of non-consolidated bone fractures (BONECURE project)

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  • It is an innovative project based on pre-differentiated mesenchymal stem cells designed to treat patients with bone consolidation problems post-fracture (atrophic pseudoarthrosis).
  • A Phase II clinical trial has been completed, with very promising results in terms of efficacy and safety, in patients with pseudoarthrosis of long bones.
  • Salvat has invested more than 10 million Euros in this project in collaboration with the biopharmaceutical company Histocell, a company specialized in regenerative medicine and cell therapies.

Salvat, an international laboratory with its headquarters in Barcelona, Spain, has completed the Phase II clinical trial of a new treatment for non-consolidated long-bone fractures (pseudoarthrosis). The clinical trial design was agreed with the Spanish Agency for Medicines and Medical Devices (AEMPS). After the application of the product, patients were followed for two years to test its efficacy and safety, by assessing the fracture healing and the appearance of adverse events. This project has been carried out in collaboration with the biopharmaceutical company Histocell, which specializes in regenerative medicine and cell therapies.

Salvat’s new treatment is based on pre-differentiated allogeneic mesenchymal stem cells that are implanted in a calcium phosphate biomaterial and applied directly into the lesion site. Salvat has invested more than 10 million Euros in developing this innovative therapy.

 

Very positive results

Salvat has completed the Phase II clinical trial and the results are very promising. The research has been conducted at the Teknon Medical Center in Barcelona and the Hospital Universitario La Paz in Madrid. Patients affected by atrophic pseudoarthrosis have serious problems in consolidating their fracture. In fact, in many cases, the fractures must be re-intervened surgically on several occasions, and nowadays there is no effective treatment for these situations. This condition has a big impact on patients’ daily functionality, as well as a very high health expenditure due to the cost of medical care. BONECURE is intended to achieve a good and faster bone consolidation allowing for a more complete functional recovery.

Based on these good results, Salvat plans now to continue with the clinical development, which will be discussed with the European Medicines Agency (EMA) in a Scientific Advice Meeting. The possibility of extending the research to other bone pathologies will also be discussed.

 

Long bones are the most difficult to consolidate

The new treatment is indicated for pseudoarthrosis or broken bone that has not consolidated. Usually, a period of 9 months is required before a fracture is considered to have healed correctly. Although it is not a very frequent complication (4% of fractures), pseudoarthrosis requires a great deal of attention from traumatologists, and some cases require more than three surgeries, being also highly painful and dysfunctional.

Long bones are the ones that break most easily and cost the most to consolidate. The fracture of the tibia is one of the most common bone fractures and one of the most likely to develop pseudoarthrosis.

Salvat plans to launch the first global ocular corticosteroid with nanoemulsion in 2023 for the inflammation and pain after ocular surgery

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    • Phase III clinical trials conducted in US confirm that clobetasol is effective and safe in the treatment of inflammation and pain after cataract surgery.
    • The pharmaceutical company has begun the process with health authorities to market the new corticosteroid worldwide by the middle of next year.
    • The company has patented a pioneering technology, IMPACT-SVT®, which for the first time in the field of ophthalmology will make possible to use this active ingredient as nanoemulsion.
    • With this project, of 20 million euros investment, Salvat takes another step forward in its strategy to establish itself as a key player in the field of ophthalmology at an international level.

    Salvat, international manufacturer of products like Otovel and Cetraxal, has successfully finished the phase III clinical trials of its new and innovative ocular corticosteroid with clobetasol for the treatment of inflammation and pain in cataract surgery patients. The trials, conducted during 2020 and 2021 in more than 400 patients in the United States, and in more than 40 specialized centers, have demonstrated the efficacy and safety of clobetasol. The company has initiated the approval application procedures with the Food and Drug Administration (FDA) and the European health authorities to launch the new corticosteroid worldwide in the second half of 2023.

    Bringing the Strongest Corticosteroid to the Global Ophthalmology Market

    It’s the first time that this active ingredient, considered a “superpotent” corticosteroid will be used in the field of ophthalmology. Moreover, its formulation as a nanoemulsion with its proprietary IMPACT-SVT® technology and the presentation in single-dose vials offers superior advantages over other alternatives on the market. In addition to its efficacy and safety, clinical trials have shown that, unlike many other corticosteroids, it does not increase intraocular pressure. Another differential aspect is that it does not require a gradual decrease in dosage before the end of treatment, since it has been proven that after the initial 14 days of treatment and 14 more days of follow-up without medication, there is no rebound inflammation or pain. Finally, the nanoemulsion technology, IMPACT-SVT® delivers the lowest drug concentration by dissolving clobetasol in nanodroplets size. This results in a much more comfortable application providing maximum adherence, penetration and avoids blurred vision to the patient.

    Trials with positive results

    The two clinical trials of the new drug conducted last year in the United States involved a total of 426 cataract surgery patients, of whom 281 received clobetasol and 145 received a placebo. Both studies achieved their objective of demonstrating the efficacy and safety of clobetasol by finding significant differences against the placebo not only in the main variable of the studies, which was the total absence of inflammation after the first 7 days of treatment, but also in the vast majority of ocular parameters evaluated.

    Single Dose Manufacturing Technology

    One of the advantages of Salvat’ BFS technology is to manufacture the product in a totally sterile environment, thus ensuring a sterile single dose vial at the time of application. The unit dose format offers a more convenient use and also optimizes the compliance with the treatment, since it allows the exact dose administration. This innovative product will be the first unit dose therapy on the market indicated for the treatment of inflammation and pain after ocular surgery.

    Designed with BFS technology, the new drug will be produced in the manufacturing line of Salvat USA Inc. in Miami (Florida) and in the Pharmaloop S.L. plant, in Madrid. Both companies are subsidiaries of Laboratorios Salvat S.A. Following the processing and application for approval by the various health authorities, Salvat expects to start marketing its new corticosteroid worldwide in mid-2023. The main focus will be on the United States and Europe, where the company has its own sales network, in addition to its headquarters in Barcelona and the manufacturing plant located in Madrid. In the US market and other countries, distribution will be done through local strategic partners.

    Salvat, a key player in ophthalmology

    In addition to the development of this ocular corticosteroid, which has involved an investment of more than 20 million euros, Salvat is working on four other projects in the field of ophthalmology, such as glaucoma, dry eye, diabetic retinopathy and blepharitis.

    For Alberto Bueno, CEO of Salvat, “the launch of the new corticosteroid and the rest of the projects that are underway reinforce our ophthalmology line as one of our main areas of research and development, and strengthen the company’s strategy to position itself as one of the main players in the field of ophthalmology worldwide in the coming years.”

Salvat Laboratories enters in the Hong Kong market with its first otic medication

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  • Salvat has an agreement with Lee’s Pharmaceutical to distribute the otic treatment Cetraxal Plus in China, Hong Kong and Taiwan.
  • The product has been available in the Spanish market for twenty years and is exported to more than 50 countries.
  • Cetraxal Plus is the only otic treatment in the world that comes in single-dose vials for acute otitis externa and otitis media with tympanostomy tubes.
  • With this project, Salvat reinforces its commitment to the Asian market, where it is already present in markets such as Korea, Singapore and Vietnam.

Salvat Laboratories (“Salvat”) and Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm”) (SEHK Stock Code:0950) have launched Salvat Cetraxal Plus otic treatment in Hong Kong, marking the first time the laboratory has operated in the Asian country.

Lee’s Pharmaceutical acquired the license rights from Salvat to sell Cetraxal Plus in China, Taiwan and Hong Kong in single-dose vials. Following clinical trials and official approvals the treatment has started to be marketed this October in Hong Kong and is scheduled to be marketed in China and Taiwan next year. “The Asian market, and especially China, are strategic markets for Salvat due to their growth potential and high demand for health and self-care products”, explains Alberto Bueno, CEO of Salvat.

Clinical trials in China

In China, the Phase III clinical trial for the drug is currently underway and most of the necessary patients have already been recruited from 44 centers across the country. The study is led by researchers from Fudan University and is scheduled to be completed before the end of 2021. The final phase will be the regulatory process for the product’s approval in the country.

This clinical trial is the prerequisite for obtaining authorization from the Chinese National Medical Products Administration to market the drug, in their country.

The world’ s first treatment in single-dose vials for both otic conditions

Cetraxal Plus is the only otic treatment in the world for acute otitis externa and otitis media with tympanostomy tubes that comes in single-dose or single-use vials. This presents several benefits over multidose formats, as it facilitates correct administration with the exact amount of product and maintains the sterility of the treatment. “At Salvat, we are committed to technology and innovation in drug development and the single-dose formats allow us to offer increasingly advanced solutions adapted to the needs of the market. We manufacture them in the production lines owned by the Salvat Group: “Salvat (Barcelona), Pharmaloop (Alcalá de Henares, Madrid) and Tamarac (Florida, USA)” explains the CEO of Salvat, Alberto Bueno.

With almost twenty years on the market, Cetraxal Plus has become one of Salvat’s key products. It is a treatment for acute otitis externa and otitis media with tympanostomy tubes that combines an antibiotic and a corticosteroid. Every year more than 1,500,000 units are sold in Spain and more than 3,000,000 are exported to 50 countries around the world.

Salvat completes Phase III clinical trials of its new ophthalmic corticosteroid nanoemulsion

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  • The aim of these trials, which began in 2020, is to prove the efficacy of this innovative drug in treating ocular inflammation and pain after cataract surgery.
  • For the first time in the world, this new product will use nanoparticles applied to the eye in order to help the drug’s absorption and application.
  • With an investment of more than 12 million dollars, the project seeks to strengthen Salvat’s position in the United States. After receiving authorization for its commercialization, the drug will be produced in the Salvat USA Inc. production lines in Miami (Florida).

Salvat, an international laboratory with a wide experience in commercializing ophthalmic products around the world, has completed the Phase III clinical trials they are conducting in the USA on their innovative drug for the treatment of ocular inflammation and pain after cataract surgery.

The trials have been carried out despite the pandemic. They represent a strategic project for Salvat, since, with an investment of more than 12 million dollars, they seek to reinforce the company’s position in the ophthalmology field worldwide. According to Alberto Bueno, Salvat’s CEO, “these trials also prove Laboratorios Salvat’s commitment to R&D and growth in the North American market”, where the drug is expected to be marketed by the end of 2022. Authorization is also expected to be granted in Spain and in most European countries and other geographical areas by 2023.

The clinical trials were agreed with the Food and Drug Administration (FDA), started in 2020 and have involved 400 adult patients who had recently undergone cataract surgery coming from 50 US hospitals, despite the difficulties resulting from the COVID-19 pandemic.

Once the patient recruitment phase has been completed, results are expected to be available early in the second half of 2021 and the registration documentation will be submitted by the end of 2021. After receiving authorization for its commercialization in the USA and Europe, the drug will be produced in the Salvat USA Inc. plants in Miami (Florida) and Pharmaloop, S.L. in Alcalá de Henares (Madrid). Both companies are subsidiaries of Laboratorios Salvat S.A.

The first eye drug with nanoparticles

This drug, which treats pain and inflammation in patients who have undergone eye surgery, presents two main innovations. First, the type of corticosteroid used, which is classified as “superpotent”, and which had not been used before in eye drops. Secondly, the type of formulation used, a nanoemulsion that has many advantages over current treatments and has never been used before in eye corticosteroids. The nanoemulsion formulation (which is a nanometric-sized emulsion) increases tolerability, easily reaches the entire eye, prevents blurred vision and is more comfortable for the patient.

In the USA alone, around four million cataract surgeries are performed every year. This drug under development will be a great advance in the treatment of pain and inflammation after eye surgery, both because of its active ingredient and its formulation.

Salvat Laboratories, pioneer in Ophthalmology

In addition to developing this ocular corticosteroid, Salvat is working on four more projects in the field of ophthalmology. Two in the area of glaucoma and two in the area of dry eye. This new drug for pain and inflammation after cataract surgery confirms Salvat’s commitment to this medical specialty and the company’s desire to strengthen its leadership in the treatment of eye diseases.

The Secretary General for Industry visits the Pharmaloop plant

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  • Mr. Raúl Blanco, Secretary General for Industry and Small and Medium Enterprises, visited Pharmaloop’s new sterile liquids plant, located in Alcalá de Henares (Madrid).
  • Pharmaloop is the first fully autonomous pharmaceutical production center in Spain, with a natural gas cogeneration system that creates its own energy.
  • The visit served to reinforce the company’s commitment to product innovation and internationalization with the construction of this 8,500 m² plant, which has also meant the creation of 100 new jobs.

Last April 9, the Secretary General for Industry and Small and Medium Enterprises, Mr. Raúl Blanco, visited Pharmaloop’s new sterile liquids plant located in Alcalá de Henares, which, thanks to its advanced technology and production processes, demonstrates the pharmaceutical group’s commitment to the innovation and internationalization of its products.

The Secretary, who was received by Alberto Bueno, CEO of Laboratorios Salvat, Juan de la Fuente, Site Manager of Pharmaloop, and Marisa Poncela, Non-Executive Director of Laboratorios Salvat, was accompanied by Alejandro Cros, Deputy Director General of Industrial Sector Policies, and Carmen Álvarez, Head of the Pharmaceutical Technologies Area.

During the meeting, held two months after the Minister of Industry, Reyes Maroto, visited Pharmaloop, the delegation toured the more than 8,500 m² of the new plant, considered the first fully autonomous pharmaceutical production center in Spain thanks to its cogeneration system that creates its own energy, making it less polluting.

Innovation and internationalization

The project for the new plant in Alcalá de Henares has involved an investment of 65 million euros for Laboratorios Salvat and, together with the current plant, will allow Pharmaloop to have facilities covering more than 23,000 m².

As Alberto Bueno, CEO of Salvat, explains, “with Pharmaloop, we have made a very important commitment to growth at an international level. Thanks to the new plant’s production capacity, we will be present in more markets and we will continue with the expansion strategy started a few years ago which already generates more than half of our annual turnover as a group.”

The international demand for sterile single-dose units is increasing substantially with the Covid-19 pandemic as they are necessary to produce vaccines and other pharmaceutical products. With the plant completed and fully operational, Salvat will have a production potential of 500 million sterile vials per year.

This plant is at the forefront of technology. It is fully automated and uses some of the most advanced systems for drug production such as BFS (Blow, Fill and Seal). Likewise, it applies the most comprehensive quality tests, with 100% of its vials checked to avoid leaks, not just a random sampling of vials as occurs with other control systems.

The company’s forecast is to increase the number of collaborators in the coming months to reach more than 70 countries – it is currently in 60 – and to position itself as a global benchmark in the manufacture of sterile single-dose liquids.