BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 28, 2023
EyePoint Pharmaceuticals, Inc. a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced it has completed enrollment in the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (wet AMD). The trial exceeded its original target of 144 patients, enrolling a total of 160 patients. All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 or to an aflibercept on-label control.
“We are thrilled to announce the completion of enrollment in our oversubscribed Phase 2 DAVIO 2 trial evaluating EYP-1901 in wet AMD, marking an important milestone as we continue to advance our pipeline of innovative sustained delivery treatments for serious eye disorders,” said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “Patients with wet AMD face an immense treatment burden, requiring monthly or bi-monthly eye injections for the rest of their lives in order to prevent severe vision loss. The high level of patient and physician interest we saw in the trial enrollment further demonstrates the great unmet need in this population for a maintenance treatment option that is safe, effective, long-lasting and convenient.”
“We look forward to reporting topline data in the fourth quarter of this year. With these data and the promising results from our Phase 1 DAVIO trial, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. These data will inform the design of our pivotal Phase 3 clinical trials and provide optionality as we seek to bring this promising product to patients. I would like to thank our dedicated team of employees and clinical partners, as well as the patients who enrolled in the Phase 1 and Phase 2 EYP-1901 trials and their caregivers for advancing the development of EYP-1901,” continued Ms. Lurker.
DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety.
“Our ‘Treat to Maintain’ therapeutic approach for EYP-1901 has the potential to transform the wet AMD treatment paradigm, and we are incredibly pleased to complete enrollment with more patients than planned in the DAVIO 2 clinical trial due to high demand to participate from investigators and patients,” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “The compelling Phase 1 DAVIO results demonstrate EYP-1901’s potential to transition a majority of patients to an every-six-month treatment for wet AMD, representing a ‘treat to maintain’ therapeutic approach that uses EYP-1901 as a baseline therapy following the use of large molecule anti-VEGFs with the goal of significantly extending the patient’s treatment interval. Based on the extensive prior clinical data evaluating Durasert in four FDA-approved indications, we are confident in EYP-1901’s ability to consistently deliver the active drug, vorolanib, with zero-order drug release kinetics using our bioerodible sustained delivery technology, Durasert® E. In addition, vorolanib brings a new mechanism of action for wet AMD patients and may have additional neuroprotective benefits. We are confident in EYP-1901’s potential to enhance treatment compliance, improve clinical experience and, ultimately, result in better patient outcomes.”
EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology (Durasert® E) with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed a positive safety profile with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned in diabetic macular edema. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ® for the treatment of posterior segment uveitis, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
Globenewswire | May 15, 2023
Viridian Therapeutics, Inc. a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, announced a new partnership with Enable Injections, a company developing and manufacturing the enFuse® innovative wearable drug delivery system for volumes of up to 25mL.
“As we expand our pipeline beyond TED and assess the unmet needs of patients living with other serious and rare diseases, it’s clear that convenient drug delivery is an important issue,” said Scott Myers, President and CEO of Viridian. “We believe Enable’s proprietary technology can contribute meaningfully to our goal of delivering therapeutic advances while reducing patient treatment burden as well.”
“Enable Injections is excited to partner with Viridian to utilize the enFuse® technology to enhance the patient experience,” said Michael D. Hooven, Enable Injections' Chairman and CEO. “The enFuse® on-body delivery system was engineered with the patient in mind—the hidden needle and hands-free delivery allows patients to have increased flexibility, improved convenience, and the ability to administer medication discreetly, whether at home via self-administration or in the clinic.”
This partnership, which applies exclusively to areas outside of Viridian's established TED portfolio, underscores the company's commitment to patient-centric innovation.
About Viridian Therapeutics
Viridian Therapeutics is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The Company has initiated its first global Phase 3 trial called ‘THRIVE’ to evaluate the safety and efficacy of VRDN-001 in patients with active TED. Viridian is also evaluating VRDN-001 in a Phase 2 proof-of-concept trial in patients with chronic TED. In addition to its program for intravenously administered VRDN-001, the Company is advancing three candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with TED. Viridian is also developing multiple preclinical assets in autoimmune and rare diseases.
businesswire | May 18, 2023
Mednow Inc Canada’s on-demand virtual pharmacy has been named the preferred virtual pharmacy partner for Medcan Health Management Inc. and its valued clients.
Mednow is focused on improving the delivery of pharmacy services in Canada through digitization to provide better patient access to pharmacists, doctors and other healthcare professionals.
Mednow offers instant access to pharmacists in the Mednow app or on the phone and offers fast, free delivery of prescription medication.
“At Medcan, we’re always striving to bring our valued clients the highest level of service and incredible level of care through integrated, comprehensive and convenient health and wellness services, including ensuring they have easy access to a premium pharmacy experience,” said Shaun Francis, CEO and Chair of Medcan.
“By partnering with Mednow, our Medcan clients will not only have a new option to get their prescription medications, over the counter products or supplements, but also the added benefit of always-on access to knowledgeable pharmacists who can help ensure they’re taking medications correctly,” said Francis.
“Mednow is proud to partner with Medcan, a pioneer in high quality healthcare in Canada and an ideal partner to work with to reduce care fragmentation and enhance collaboration between our two healthcare professions,” said Ali Reyhany, CEO and Co-Founder of Mednow.
“Our proprietary technology provides seamless access to our pharmacy team, which deploys the latest health technologies and best practices in pharmacy to optimize patient care. Texting your pharmacist, automatic refill reminders and the availability of Pillsmart™ medication packs are just some of the ways Mednow can help Medcan’s mutual patients,” said Reyhany.
Mednow is a healthcare technology company offering virtual access with a high-standard of care. Designed with accessibility and quality of care in mind, Mednow provides virtual pharmacy and telemedicine services as well as doctor home visits through an interdisciplinary approach to healthcare that is focused on the patient experience. Mednow’s services include free at-home delivery of medications, doctor consultations, a user- friendly interface for easy upload, transfer, and refill of prescriptions, access to healthcare professionals through an intuitive chat experience and the specialized PillSmart™ system that packages prescriptions in easy-to-use daily dose packs, each labelled with the date and time of the next dose.