SpyGlass Pharma Inc

Mean intraocular pressure (IOP) was reduced by 43.7% from baseline at month 18All patients remained off topical IOP-lowering medications and achieved >20% IOP reductionAll eyes achieved Visual Acuity (BCDVA) of 20/30 or better ALISO VIEJO, Calif., Oct. 17, 2024 (GLOBE NEWSWIRE) -- SpyGlass Pharma™, a privately-held ophthalmic biotechnology company, released 18-month follow-up data from a first-in-human study of 23 patients with glaucoma or ocular hypertension implanted with the SpyGlass Intraocular Lens (IOL) based Drug Delivery Platform at the time of cataract surgery. These data were presented today during the Eyecelerator Ophthalmic Innovation Conference prior to the American Academy of Ophthalmology annual meeting in Chicago, Ill. The sustained reduction of intraocular pressure (IOP) was consistent across all three dose strengths, achieving a mean pressure reduction of 43.7% at month 18 compared with baseline. Additionally, 100% of patients remained off all topical IOP-lowering drops. All patients achieved an IOP reduction of more than 20% from baseline and 96% of patients maintained an IOP ≤18 mmHg through month 18. The SpyGlass platform was well-tolerated and there were no product related adverse events. “The clinical results achieved by the SpyGlass Drug Delivery Platform, now 18 months post implantation, continue to be compelling for ophthalmic surgeons and for patients living with glaucoma,” said Malik Kahook, M.D., Co-founder of SpyGlass Pharma™. “Long-term drug delivery of trusted medicine is a major unmet need for patients living with chronic eye conditions. The results presented showcase the potential of the SpyGlass Drug Delivery Platform to be a game changer for glaucoma patients and all cataract surgeons.” “The SpyGlass technology continues to demonstrate great potential for improving care in glaucoma patients undergoing routine cataract surgery,” said Patrick Mooney, CEO, SpyGlass Pharma™. "Approximately 1 million cataract surgeries are performed each year in patients with glaucoma or ocular hypertension in the United States alone. Beyond our compelling clinical data, the SpyGlass technology is implanted utilizing standard surgical techniques that every cataract surgeon knows by heart. So often, new technology requires new surgical skills to learn, which can limit surgeon adoption. With SpyGlass technology, cataract surgeons will use their proven implantation techniques which makes the potential adoption of SpyGlass’ Drug Delivery Platform three times greater than existing interventional glaucoma devices in market today.” ABOUT SPYGLASS PHARMA The SpyGlass Drug Delivery Platform with bimatoprost is designed to deliver 3 years of bimatoprost to targeted tissues. Patients in the first-in-human study will continue to be followed over time, and the Company plans to share longer-term data in the coming months. SpyGlass is on track to complete enrollment this year in a Phase I/II study in the United States to investigate the safety and efficacy of its platform in a larger patient pool. SpyGlass looks forward to working closely with the U.S. Food and Drug Administration (FDA) to advance the program to commercial approval. SpyGlass Pharma was co-founded by Dr. Malik Y. Kahook, M.D. and Glenn Sussman. The company is focused on the development of the world’s first, IOL-mounted, controlled release drug delivery platform capable of delivering multiple years of therapy. The technology was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine and spun off campus post Series A funding. http://www.spyglasspharma.com Media Contact: Angela Salerno-Robin 312-545-9331 asalerno-robin@dna-comms.com

Share Mean intraocular pressure (IOP) reduction from washed-out baseline was 44.6% at Month 12; all patients had IOP reduction >20% and IOP ≤ 18 mmHg. 100% of patients remained off topical IOP-lowering medications.All eyes achieved Visual Acuity (BCDVA) of 20/40 or better. ALISO VIEJO, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- SpyGlass Pharma™, a privately-held ophthalmic biotechnology company, announced today 1-year follow up data from a first-in-human study of 23 patients with glaucoma or ocular hypertension implanted with SpyGlass’ Intraocular Lens (IOL) based Drug Delivery Platform with bimatoprost at the time of cataract surgery. These data will be highlighted in a poster presentation during the American Society of Cataract and Refractive Surgeons (ASCRS) Annual Meeting, held from April 5-8 in Boston. One year after implantation, the enduring intraocular pressure (IOP) reduction remained consistent across all three dose strengths, achieving a mean pressure reduction of 44.6% at month 12 compared to pre-operative washed-out baseline levels. All patients sustained more than a 20% IOP reduction from baseline and IOPs of ≤18 mmHg through month 12. Additionally, 100% of patients remain off topical IOP-lowering drops. The SpyGlass platform was well tolerated and there were no adverse events related to the product. “The clinical results, one year after implantation, continue to be highly encouraging for patients living with glaucoma,” said Margot Goodkin, M.D., Ph.D., Chief Medical Officer, SpyGlass Pharma™. “Bimatoprost has provided patients across the globe with safe, highly effective IOP-lowering for over 2 decades. These data highlight the substantial potential of the SpyGlass Drug Delivery Platform to be a game changer for patients and all cataract surgeons.” “SpyGlass technology has the potential to change the paradigm and improve care for glaucoma patients undergoing routine cataract surgery,” said Patrick Mooney, CEO, SpyGlass PharmaTM. "There are nearly 5 million annual cataract procedures in the United States, approximately 20% of them are performed in patients with glaucoma or ocular hypertension. The unmet need is significant, and SpyGlass is committed to delivering safe and effective therapeutics via proven implantation techniques to improve the lives of patients living with chronic eye conditions. The compelling clinical data released this week suggest we are on track to bringing our innovative platform to patients.” The SpyGlass Drug Delivery Platform with bimatoprost is designed to deliver 3 years of bimatoprost to targeted tissues. Patients will continue to be followed over time and the Company plans to share longer-term data in the coming months. SpyGlass is currently enrolling patients in a Phase I/II study in the United States to investigate the safety and efficacy of its platform in a larger patient pool. SpyGlass looks forward to working closely with FDA to advance the program to commercial approval. ABOUT SPYGLASS PHARMASpyGlass Pharma was Co-founded by Dr. Malik Y. Kahook, MD and Glenn Sussman. The company is focused on the development of the world’s first, IOL-mounted, controlled release drug delivery platform capable of delivering multiple years of therapy. The technology was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine and spun off campus post Series A funding from New Enterprise Associates. http://www.spyglasspharma.com Media Contact: Claudia Penido 917-763-8733 Cpenido@dna-comms.com

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  BIO lands rare disease advocate John Crowley as CEO Biotechnology Innovation Organization For more than a year, the Biotechnology Innovation Organization (BIO) has been led by interim CEO Rachel King. Now, the organization has named a permanent successor.  Rare disease advocate, biotech founder and BIO board member John Crowley is set to take the top spot starting March 4. Crowley is probably best known for his entrepreneurship in the industry after his two youngest children were diagnosed with Pompe disease, a rare genetic neuromuscular disorder. He co-founded Novazyme Pharmaceuticals (acquired by Genzyme) and served as a founding leader for Orexigen Therapeutics and Amicus Therapeutics, where he served as CEO from 2005-2022. Crowley currently serves as Amicus’ executive chair and will stay in that role until March.  The military veteran’s search for a Pompe disease treatment was documented in the 2010 movie Extraordinary Measures, directed by Harrison Ford. Crowley will take the reins of the advocacy organization as the industry continues to brace itself against potential implications of the IRA and challenging market conditions. Release  Cyclerion Therapeutics picks former EQRx leader as new CEO  Cyclerion Therapeutics Regina Graul, Ph.D., has found a new role at the top of Cyclerion Therapeutics, replacing outgoing founding CEO Peter Hecht, Ph.D. It’s a return to home for the executive, who previously led development of Cylcerion’s olinciguat program for cardiovascular disease. Graul comes from EQRx, a biotech that had attempted to make low-cost oncology drugs but ultimately shut down earlier this year. There, Graul served as a program executive overseeing cross-functional development teams in oncology. Graul will have a challenging job in front of her. Cyclerion has been through a tough few years, shifting clinical plans twice in 2022. “As we evaluate our existing assets and identify external value-creating opportunities, cutting-edge innovation and addressing unmet patient needs will be central tenets,” Graul said in a statement. The new CEO is effective immediately. However, Hecht will continue as a strategic consultant and board director. Release Sensorium selects new CEO Sensorium Therapeutics Psychoactive medicine-focused Sensorium has selected Alexandra (Sandra) Glucksmann, Ph.D., to helm the biotech as former CEO and co-founder Dick Simon transitions to an advisory role.  Simon held the role since helping launch the nature-inspired platform company in 2021. New CEO Glucksmann has more than 30 years of industry experience, most recently serving as founding CEO and president of oncology company Cedilla Therapeutics. She also served as the founding chief operating officer for gene editing company Editas Medicine and currently holds board spots at REGENXBIO and Scenic Biotech. Release  > Three years on, Bristol Myers Squibb is bidding adieu to its top dealmaker. Elizabeth Mily, who replaced BMS’ former M&A czar Paul Biondi back in 2020, is headed for the exit after joining the pharma company in spring of 2020 from Barclays. Her departure has prompted BMS to launch a search for a replacement, with the company's spokesperson noting that "strategy and business development is critical to our business strategy." Fierce Pharma > Bob Smith has left Merck & Co. for Gossamer Bio, where he will serve as chief commercial officer. Smith most recently led Merck’s sotatercept pre-launch activities in the U.S. as the national sales lead, and previously led U.S. sales operations for Actelion. Release > Ophthalmic biotech SpyGlass Pharma has selected Margot Goodkin, M.D., Ph.D., to serve as chief medical officer. Before SpyGlass, Goodkin was executive director of ophthalmology clinical development at Allergan/AbbVie and also previously worked at the FDA’s Center for Devices and Radiologic Health. Release > Kling Bio has tapped Stefano Gullà, Ph.D., to serve as chief scientific officer. Before joining Kling, Gullà has held senior roles at Pfizer, Agenus, Flagship and RVAC. Release > As part of a layoff round, Theseus Pharmaceuticals has sent CEO and President Timothy Clackson, Ph.D., and Chief Medical Officer David Kerstein, M.D., packing. Release > Zenas BioPharma is welcoming Jennifer Fox on as chief business officer and chief financial officer, as well as Tanya Fischer, M.D., Ph.D., as head of R&D and chief medical officer. Before Zenas, Fox served as Nuvation Bio’s chief financial officer, while Fischer served as Biohaven’s chief development officer and head of translational medicine. Release > Catalyst Pharmaceuticals has appointed Michael Kalb—who most recently served Impel Pharmaceutical’s chief financial officer, as its EVP and CFO—as current CFO Alicia Grande retires at the end of the year after a 16-year tenure with the company. Catalyst is also promoting Steven Miller, Ph.D., to EVP, chief operating and scientific officer, while Jeffrey Del Carmen has been promoted to EVP and chief commercial officer. Release > Alentis Therapeutics has appointed Rizwan Velji to serve as chief business officer. He joins the Swiss biotech from William Blair, where he most recently served as managing director. Release > While Hepion Pharmaceuticals’ board has approved a plan designed to slash operating costs by 60%, CEO Robert Foster, Ph.D., has resigned, citing personal reasons. Chief Financial Officer John Cavan has stepped up and will lead the biotech as interim CEO. Fierce Biotech > ARTBIO has closed a $90 million series A round and hired a handful of new executives. Philippe Dasse, Ph.D., previously head of technical operations for radioligand therapies at Novartis, will be the chief technical officer, while Daniel Rossett will be SVP and head of supply chain and external manufacturing. Rossett was global head of supply chain at Novartis’ radiopharma unit, Advanced Accelerator Applications. Fierce Biotech > Empress Therapeutics has chosen Virginia Finnerty-Brooks to serve as the biotech’s chief business officer. Finnerty-Brooks holds more than 25 years of industry experience, holding roles across Adanate, Eli Lilly’s Dermira, DSM Biomedical, Cellastra, Precigen, FibroGen and EPL Technologies. Release