Retinal Telangiectasis

- Priority review granted with a PDUFA goal date set for December 17, 2024. CUMBERLAND, R.I.--(BUSINESS WIRE)-- Neurotech Pharmaceuticals, Inc., an innovator in sustained drug delivery for chronic retinal diseases, announces that the U.S. Food and Drug Administration (FDA), has determined that the Biologic License Application (BLA) for NT-501, an investigational encapsulated cell therapy for the treatment of MacTel, is sufficiently complete to permit a substantive review. The application has a prescription drug user fee act (PDUFA) goal date of December 17, 2024. MacTel is a progressive, neurodegenerative disease of the retina that results in the deterioration of central vision, significantly impacting patients' quality of life. NT-501 is an ocular implant designed to deliver sustained therapeutic doses of ciliary neurotrophic factor (CNTF) directly to the retina to slow the progression of the disease. “This is a significant achievement for Neurotech,” said Richard Small, Chief Executive Officer. “I would like to express my gratitude to our employees for reaching this important milestone.” About Macular Telangiectasia (MacTel) MacTel, or idiopathic juxtafoveal macular telangiectasia, is a rare neurodegenerative disease with characteristic localized retinal degeneration with secondary alterations of the retinal vasculature.1 MacTel typically affects both eyes and causes deterioration in central vision impacting patients’ quality of life. About Encapsulated Cell Therapy (ECT) The ECT platform is a cell-based delivery system that was designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic retinal diseases. This versatile platform consists of a small, semi-permeable capsule containing proprietary allogeneic RPE cells genetically engineered to produce specific therapeutic proteins for targeted disease treatment. The capsule is surgically inserted into the patient’s vitreous and sutured to the sclera during an outpatient procedure. Once in place, the capsule's semi-permeable membrane allows essential nutrients to enter, while also permitting the therapeutic proteins to exit into the vitreous, providing targeted and continuous treatment. Simultaneously, the membrane protects the encapsulated RPE cells from the host's immune system, ensuring their long-term survival and functionality. About NT-501 Implant NT-501 leverages our ECT platform to deliver CNTF for the treatment of chronic retinal diseases, such as MacTel. CNTF is a potent neuroprotective protein that promotes the survival and maintenance of photoreceptors. This targeted therapy provides sustained delivery of CNTF, aiming to slow retinal degeneration and potentially improve long-term visual outcomes for patients. About Neurotech Pharmaceuticals, Inc. Neurotech Pharmaceuticals, Inc. is a private, clinical stage biotechnology company and an innovator in sustained drug delivery for chronic retinal diseases. The core platform technology, ECT, enables continuous production of therapeutic proteins to the back of the eye. For more information about us, please visit . 1. Charbel Issa P, Gillies MC, Chew EY, Heeren TFC, Bird AC, Peto T, Holz FG, Scholl HPN (2013) Macular Telangiectasia Type 2.

Investigational New Drug enabling studies initiated: On track for first-in-human trials in 2025 SAN CARLOS, Calif., April 25, 2024 /PRNewswire/ -- RevOpsis Therapeutics, a next-generation biopharmaceutical company spearheading innovation in ophthalmic therapies, announced today it has successfully closed its first seed funding round, raising $16.5 million to propel its mission to develop and commercialize treatments for chronic multifactorial diseases through the company's fully human multispecific proprietary Rev-Mod Platform. The $16.5 million raised includes $7.5 million in non-dilutive capital. The financing will fund the completion of the Investigational New Drug (IND) enabling studies to secure FDA authorization and conduct the first-in-human clinical trials with the company's lead candidate, RO-104 for the treatment of neovascular age-related macular degeneration (nAMD). This seed round will also support the ongoing discovery and development of RevOpsis' pipeline, and allow the company to hire key management to drive the company forward. Neovascular AMD represents the largest retinal disease opportunity in the major global healthcare markets, with over four million patients expected to be living with the blinding disease over the next 5 years1. In 2023 alone, global nAMD revenues of anti-VEGF-A inhibitors were estimated to be approximately $9 billion. Vision gain and treatment burden remain significant unmet needs in the treatment of nAMD and other major retinal vascular diseases. RO-104 is a first-in-class modular tri-specific biologic curated to target all three dominant angiogenic pathways implicated in exudative retinal diseases. It has the potential to be the first monotherapy agent to improve visual outcomes and extend disease remission in patients suffering with nAMD. This round of funding consists of notable strategic investments including a leading contract development and manufacturing organization (CDMO) with global commercial drug supply capabilities, an ophthalmic drug and device development firm, and various private and angel investors, including several leading retina specialists. The financing milestone is anticipated to put the company on track to enable first-in-human studies with RO-104 in 2025. "This seed funding round validates our proprietary Rev-Mod platform and facilitates the development of RevOpsis' next generation multispecific antibody platform to address the unmet needs of patients suffering with sight threatening diseases," said interim CEO Dr. Ram Bhandari. "The proceeds will accelerate our ongoing IND efforts for RO-104. Additionally, the funds will be used to strengthen RevOpsis' research capabilities to further develop a pipeline of first and best-in-class retinal treatments. We are grateful for the support of our investors and excited to continue advancing the RevOpsis mission of bringing responsible and affordable therapeutic innovation to patients worldwide." With the recent infusion of capital, RevOpsis is well positioned to further develop its first-in-class lead candidate and move forward the pipeline research efforts. About RO-104 Leveraging the proprietary Rev-Mod platform, RO-104 is RevOpsis' current lead candidate. Engineered as a first-in-class fully human modular tri-specific biologic designed to address all three clinically validated dominant angiogenic pathways (VEGF-A, VEGF-C, Ang-2) implicated in retinal vascular disease progression, including neovascular age-related macular degeneration (nAMD). RO-104 represents a significant innovative advancement in the treatment landscape for retinal vascular diseases. Backed by a significant body of preclinical evidence demonstrating intended efficacy and safety in established animal models, RO-104 heralds a transformative approach positioned to redefine the current standard of care for patients with nAMD. About Rev-Mod Platform The proprietary Rev-Mod Platform employs a modular 'plug-and-play' approach to streamline and expedite the efficient discovery and development of multispecific biologics targeting a wide spectrum of chronic, prevalent, large diseases, that are the leading causes of death and disability worldwide. Our proprietary platform boasts a vast library of nearly 30 billion fully human antibody components in a structured phage display system, facilitating rapid identification and assembly of multispecific product candidates. With seamless compatibility, the Rev-Mod platform enables swift and efficient design of multispecific biologics to address unmet needs in major therapeutic areas including ophthalmology, oncology, and immune-mediated diseases. About RevOpsis Therapeutics Founded in 2018, RevOpsis Therapeutics is a privately held, next-generation biopharmaceutical company spearheading innovation in ophthalmic therapies. Guided by a team of leading physicians, scientists, and business leaders, we are dedicated to leveraging our proprietary Rev-Mod Platform to develop and commercialize groundbreaking treatments for chronic multifactorial diseases. With a steadfast commitment to responsibly advancing patient care, we aim to usher in a new era of improved disease management and extended disease remission. For more information, please visit . Market Scope. "2023 Retinal Pharmaceuticals Market Report: Global Analysis for 2022 to 2028." August 2023. Retrieved from SOURCE RevOpsis

Presentations at the OIS- and Ora-sponsored Dry Horizons meeting on May 3rd, at OIS Retina on May 4th, and a poster at ARVO STUART, Fla., April 19, 2024 /PRNewswire/ -- Stuart Therapeutics, Inc., a clinical-stage ophthalmic biopharmaceutical company focused on developing therapies for the treatment of anterior segment, refractive and posterior segment eye disorders, today announced that the company will be presenting its latest research results at both the Association for Research in Vision and Ophthalmology annual meeting, and at two meetings sponsored by the Ophthalmology Innovation Source (OIS) in early May. Eric Schlumpf, Stuart Therapeutics' President and CEO, will be presenting at the Dry Horizons Symposium (co-sponsored by Ora, Inc.) on Friday May 3rd. His topic will be the company's innovative dry eye disease program, currently in a Phase 3 trial. On Saturday, May 4th he will be presenting the company's latest pre-clinical results in retinitis pigmentosa and in exudative retinal indications at the OIS Retina Meeting. Both of these meetings will be held at the Four Seasons Hotel in Seattle, Washington. Continue Reading Stuart, Florida Members of Stuart Therapeutics' R&D team also co-authored a poster presentation that is being presented by researchers from the University of Rochester at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, which will take place from May 5-9, 2024, in Seattle. The poster presentation, entitled "Scleral collagen remodeling and repair assessed in intact eyes through Second Harmonic Generation," covers work done at the University of Rochester using Stuart Therapeutics' proprietary collagen mimetic peptide platform to understand its efficacy in reversing the disruption of scleral collagen in the eye, a likely source of eye shape distortion in myopia. The study authors are Aldo Tecse, Kaitlin Wozniak, James German, Alex McMullen, Mark Buckley, Robert Baratta, Eric Schlumpf, Brian J. Del Buono, Michael Telias, and Susana Marcos. About Stuart Therapeutics, Inc. Stuart Therapeutics, founded in 2017 and based in Stuart, Florida, is the leader in the development of ECM-targeting therapeutics for disease treatment. Its platform technology, PolyCol™, is a portfolio of synthesized collagen mimetic peptides designed to specifically bind to and repair disease- or injury-damaged helical collagen structures. This activity results in both a repair of collagen structures and a restoration of homeostatic cell signaling, with positive effects on cell growth and proliferation and reduction in inflammation. These effects occur rapidly in treated tissues, and Stuart Therapeutics has extensive research results in a variety of refractive, anterior segment and posterior segment ophthalmic disease indications. For more information, visit . CONTACT: Eric Schlumpf, President & CEO [email protected] SOURCE Stuart Therapeutics