Latest news with #ranibizumab
Medscape
06-08-2025
- Health
- Medscape
Port Delivery System Outperforms Injections for DME
Implantation in the eye of the port delivery system loaded with a bolus of the antivascular endothelial growth factor ranibizumab was associated with similar improvements in visual acuity after 2 years as intravitreal injections with ranibizumab in people with diabetic macular edema, results of a subset analysis of a phase 3 trial have shown. However, anatomical improvements were more profound in the eyes treated with the port system, and they did not progress onto proliferative diabetic retinopathy or have any reports of endophthalmitis, whereas a portion of the injected eyes did, Jordan Graff, MD, reported at the American Society of Retina Specialists (ASRS) 2025 Annual Meeting in Long Beach, California. Jordan Graff, MD 'The port delivery system provides excellent pharmacokinetics and disease control with vision comparable to monthly injection and a reduction in edema that was superior to an idealized standard-of-care injection model,' Graff, a vitreoretinal surgeon at Barnet Dulaney Perkins Eye Center in Phoenix, told Medscape Medical News . 'When we looked at complicating factors, we found that the safety outcome signals were essentially equal,' he added. Study Results The subset analysis included 241 patients with diabetic macular edema in both eyes from the phase 3 Pagoda trial. In this subset, the participants had the port system implanted in the eye with worse visual acuity and central subfield thickness, an anatomical measure of edema in the eye based on optical coherence tomography. The other eye, referred to as the fellow eye, was treated with intravitreal injections of ranibizumab on the basis of the clinician's discretion. The port system is an implant about the size of a grain of rice, which is inserted into the eye. It consists of a reservoir designed to be filled with 0.2 mL of 100 mg/mL ranibizumab by injection. The implant releases the drug into the eye over 6 months for diabetic macular edema and neovascular age-related macular edema, and over 9 months for diabetic retinopathy. Participants in the Pagoda trial received the implant after 4 monthly loading doses of ranibizumab. The FDA approved the implant in February 2022. In the subset analysis, the eyes with the port system received on average nine treatments over 2 years, including the four loading doses, and one initial and four refills. The fellow eyes received 12 injections, Graff reported in presenting the results. Visual acuity improvements were similar in both groups, Graff said. The eyes with the port implants improved from 64.2 ETRDS letters at entry to 74.3 at 2 years, about 20/50 to 20/32 in terms of Snellen visual acuity; the fellow eyes from 69.5 to 75.2 letters (20/40 to 20/32 Snellen). 'What was a surprise and really encouraging to find was that the study eyes with the port, which were the worse eyes, ultimately did better than the eyes that were given ad-lib access to repeated injections in an idealized standard-of-care environment,' Graff told Medscape Medical News. Central subfield thickness in the port eyes improved from 497.8 microns upon enrollment to 274.5 microns at 2 years, Graff said. For the fellow eyes, the improvement was less dramatic: from 399.1 to 331 microns. The lower the measure, the less extensive the macular edema. The subset analysis also looked at the proportion of eyes in each group that had more than a two-step improvement in Diabetic Retinopathy Severity Score, a measure of disease activity. Slightly more than half — 50.2% — of the port eyes experienced such an improvement at 2 years vs 31.7% of the fellow eyes. Graff added the rates of endophthalmitis were similar in both groups: one patient in each. None of the eyes with the port system had an implant dislocation. The rates of vitreous hemorrhage were 10% in the port eyes and 7.5% in the fellow eyes. No eyes in the port group progressed to proliferative diabetic retinopathy, whereas seven of the injection eyes did, he said. After completing a patient preference questionnaire, 77.5% of participants said they preferred the port to standard injections, Graff said. 'Those points give us the chance to pause as retinal surgeons and think, 'If I'm not already implementing this in my diabetic patients, I need to give this another look,'' Graff told Medscape Medical News . 'We are seeing the collective learnings of using the port delivery platform starting to take effect.' Study Strengths, Limitations 'The findings reveal that in patients with bilateral diabetic macular edema that the port delivery system actually works quite well,' Raj Maturi, MD, a vitreoretinal surgeon at Midwest Eye Institute and Retina Partners Midwest in Carmel, Indiana, told Medscape Medical News . 'The visual acuity gains in this eye compared to the fellow eye that was treated are greater. It's possible this happened because they started off with worse vision to begin with, but they improved quite a bit nonetheless.' Raj Maturi, MD Maturi noted that the 12 injections the fellow eyes received over the 2-year study was 'a little low,' as the label indication recommends monthly injections. Knowing the protocol investigators followed to administer injections to the fellow eye would help to better understand those outcomes, he said. 'An ultimate strength' of the analysis was to use both routes of administration in each patient, Maturi said. 'It takes care of all the variables, as it is two eyes of the same subject, so all the systemic variables have essentially been eliminated,' he said. The fact that the fellow eyes did not improve as much as the port eyes may indicate that the chronic drug exposure the implant provides may be better than the intimate exposure of injections. 'This study helps me promote port delivery system treatment for diabetic retinopathy,' Maturi said. The Pagoda trial was funded by Genentech. Graff reported having relationships with Regeneron Pharmaceuticals and Genentech. Maturi reported having relationships with AbbVie.
Business Wire
05-08-2025
- Business
- Business Wire
Polpharma Biologics and Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar PB016
AMSTERDAM, ZUG, Switzerland & GDAŃSK, Poland--(BUSINESS WIRE)--Polpharma Biologics S.A. ('Polpharma Biologics') announces a global (except for Middle East & North Africa) licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab, an integrin receptor antagonist, (reference product: Entyvio®*), a biologic therapy indicated for moderate to severe ulcerative colitis and Crohn's disease. Under the terms of the agreement, Polpharma Biologics will lead development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialization rights worldwide, excluding Middle East & North Africa. 'This partnership reinforces our mission to broaden access to high-quality biologics that improve patient outcomes globally,' said Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group. 'Fresenius Kabi's deep commercialization experience and commitment to biosimilars make them an ideal partner for bringing PB016 to patients worldwide. Together, we are taking an important step toward addressing the rising burden of chronic inflammatory diseases.' The agreement builds on Polpharma Biologics' growing biosimilar portfolio and proven development capabilities. The company has previously brought forward multiple biosimilars — including ranibizumab and natalizumab — across global markets in partnership with leading pharmaceutical companies. This strategic collaboration strengthens both companies' commitments to expanding global access to affordable biologic medicines while supporting healthcare system sustainability. *Entyvio® is a registered trademark of Takeda. About Polpharma Biologics: Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical organizations. The expertise of Polpharma Biologics lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists. Learn more at About Fresenius Kabi: As part of the global healthcare company Fresenius, Fresenius Kabi specializes in (bio)pharmaceuticals, medical technologies and nutrition products for critical and chronic conditions. The company's products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. For more information, please visit Important Note This press release is for informational purposes only and does not constitute promotional material for PB016 in Poland or any other jurisdiction. The commercialization of proposed vedolizumab biosimilar PB016 is solely the responsibility of Fresenius Kabi, the marketing authorization holder, in accordance with all applicable laws and regulations. Disclaimer This press release is issued from Polpharma Biologics Group and is intended to provide worldwide information to healthcare professionals, media and (potential) investors about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either express or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy.
Yahoo
01-07-2025
- Health
- Yahoo
Bio Usawa Biotechnology and Bioeq AG Partner to Create Widespread Access to Vision-Saving Medicine Across Sub-Saharan Africa
Landmark partnership will democratize access to critical eye treatment for millions facing preventable blindness from diabetes complications KIGALI, Rwanda and SAN FRANCISCO and ZUG, Switzerland , July 01, 2025 (GLOBE NEWSWIRE) -- Bio Usawa Biotechnology Ltd. (Bio Usawa) and Bioeq AG today announced a groundbreaking agreement that will bring a life-changing biosimilar medicine—ranibizumab, used to treat serious retinal diseases—within reach for millions across Sub-Saharan Africa. This partnership grants Bio Usawa exclusive rights to register and commercialize Bioeq's ranibizumab biosimilar under the brand name BioUcenta™, marking a critical step forward in democratizing access to essential biologic therapies across the region. Ranibizumab, a biosimilar to Lucentis®, is a monoclonal antibody used to treat diabetic macular edema (DME), wet age-related macular degeneration (AMD), and other blinding retinal diseases. While this breakthrough therapy has been transforming lives in higher-income countries for nearly 20 years, patients across Africa have been denied access due to prohibitive costs and limited availability. This partnership aims to end that disparity, bringing hope to millions who face preventable vision loss. 'By making ranibizumab accessible in Sub-Saharan Africa, we are empowering doctors to save the vision of millions, particularly those suffering complications from diabetes—a disease that is quietly but rapidly becoming one of Africa's greatest health threats,' said Dr. Menghis Bairu, Co-founder, President and CEO of Bio Usawa. "Our partnership with Bio Usawa is core to our commitment to expanding global access to essential medicines," said Martin Huber, Managing Director of Bioeq AG. "Together, we are breaking down the barriers that have denied effective treatment for serious retinal diseases to patients across Sub-Saharan Africa for too long. Bringing a high-quality, affordable ranibizumab biosimilar to this region is a significant step towards health justice." Africa is at the front line of a growing diabetes crisis. According to the International Diabetes Federation, more than 24 million Africans were living with diabetes in 2024, with that number projected to double by 2050. Diabetic retinopathy, a leading complication, threatens the sight of up to one-third of these patients. Without timely intervention, many will face blindness—an outcome that is both preventable and tragic. BioUcenta™, administered via intravitreal injection, works by blocking abnormal blood vessel growth in the retina and preventing fluid leakage—two key causes of vision loss. The biosimilar has already been approved in both Europe and the United States and will now be registered and distributed across Sub-Saharan Africa by Bio Usawa. 'This collaboration is about equity,' added Dr. Bairu. 'Access to advanced biologic therapies should not be a privilege of geography or income. We are proud to work with Bioeq to make this a reality for Africa—ensuring that patients, regardless of where they live, can receive the care they deserve.' The agreement marks the initial fulfillment of Bio Usawa's mission to democratize access to high-quality, affordable, and proven biotherapies in low-middle income countries. By establishing local capabilities and partnerships, the initiative creates a foundation for broader access to essential medicines across the continent. The partnership also represents a new model for global health equity, demonstrating how innovative collaborations can bridge the gap between life-saving medical advances and the patients who need them most. Rather than accepting that cutting-edge treatments remain exclusive to wealthy nations, this agreement shows how strategic partnerships can extend medical breakthroughs to underserved populations. About Bio Usawa Bio Usawa is an African biotechnology company with a mission to expand access to affordable, high-quality biosimilars across the continent. By combining deep industry experience with regional partnerships, Bio Usawa is building a future where life-saving biomedicines are made in Africa, by Africans, for Africans—and beyond. For more information, visit About Bioeq AG Bioeq AG is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. Bioeq develops and licenses biosimilars for global markets, combining innovation and quality to improve patient access to vital therapies. Learn more at Media Contact:Daniel LevineLevine Media Group+1 510-280-5405danny@ in to access your portfolio
