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 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.

• • 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.”

• 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 Minister of Industry, Reyes Maroto, visited Salvat’s new facility today, accompanied by the Mayor of Alcalá de Henares, Javier Rodriguez Palacios and Salvat CEO, Alberto Bueno
• The new 8,500 m² plant is equipped with the most advanced technology, highest quality standards and the capacity to produce more than 350 million units of sterile formulations per year
• This is the first fully autonomous pharmaceutical production center in Spain, with a cogeneration system that creates its own energy and minimizes pollution
• The activation of this plant has created over 100 qualified jobs and 30 new hires will be added in the coming months

Mr. Javier Rodriguez Palacios, Her Excellency Mrs. Reyes Maroto, Mr. Alberto Bueno

The Minister of Industry, Reyes Maroto, visited the Pharmaloop new sterile liquids production plant, in Alcalá de Henares. This plant exemplifies Salvat’s commitment to innovation and local job creation.  During the visit, she was accompanied by the Mayor of Alcalá de Henares, Javier Rodriguez Palacios and the CEO of the Salvat Group, Alberto Bueno.

The delegation toured the plant, which is equipped with the highest technology in medical production. The visit also included an in-depth walk through the facility’s laboratory, manufacturing area, automated warehouse and energy cogeneration plant.

This project, now entering its second phase, will reach a total investment of 65 million euros and represents an important commitment to international company growth. Currently, Salvat is present in 60 markets but this new facility will expand its reach to over 70 markets, with special focus on the US, Europe and Asia. Additionally, the new plant will have installations of more than 23.000 m² and will allow Salvat to increase production to 500 million sterile vials per year.

As Alberto Bueno, Salvat’s CEO explains, “With Pharmaloop, we have made a very important commitment to growth at an international level. Thanks to the production capacity of the new plant, 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 group’s annual turnover”.

The new Pharmaloop facility enhances production capabilities for the globe

The objective of the new facility is to produce for the world’s sterile liquids market, primarily North American. In addition to the previous need for single dose formats, the COVID-19 pandemic has increased demand dramatically, as this delivery system is a perfect fit for vaccines and other sterile pharmaceuticals.

“The manufacture of sterile single-dose liquids is a complex process that requires very advanced technology. Pharmaloop is a clear example of our commitment to advanced formulations in innovation, and thanks to this commitment, we will strength our presence internationally, especially in the United States” explains Alberto Bueno, CEO of Group Salvat.

The plant has the most advanced technology in medical production, such as the BFS (Blow, Fill and Seal) system. This formulation has exhaustive quality controls that ensure 100% of the vials are checked to avoid leaks.

Smart and sustainable facility

Pharmaloop is an 8,500 m², fully automated and sustainable small building that does not generate atmospheric emissions or noise.

It has a cogeneration system that transforms gas into electrical energy and allows it to operate completely autonomous. It also has a system that recovers the residual heat from the gases to produce hot water and steam.

The new facility has generated the creation of 100 qualified jobs, in addition to the 52 employees who already worked at the plant before its expansion. With this amplification, Salvat increases its production capacity and distinguishes itself as a leader in sterile liquid manufacturing with a truly international focus. The Group’s goal is to continue Salvat’s current growth trajectory with the aim of reaching 100 million euros in turnover. The company’s forecast is to grow by 30 people in the coming months and reach more than 70 countries in order to continue serving customers and patients worldwide.