ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) approved ONAPGO (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). Supernus will make ONAPGO available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch.

Over 100,000 patients in the United States have IPF, with only two approved therapies available that only slow the course of disease progression

Top line data expected in the first half of 2026

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced full enrollment of the TETON 1 study evaluating the use of Tyvaso® (treprostinil) inhalation solution (nebulized Tyvaso) for the treatment of idiopathic pulmonary fibrosis (IPF).

WASHINGTON and SAN DIEGO, Feb. 3, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) and AnaptysBio, Inc. (Anaptys) (Nasdaq: ANAB) today announced an exclusive, global license agreement for the development and commercialization of imsidolimab (IL-36R antagonist mAb), which has successfully completed two registration-enabling global Phase 3 trials, GEMINI-1 and GEMINI-2, evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis (GPP).

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company’s investigational UKidney™ derived from a 10 gene-edited source pig. The study will enroll an initial cohort of six end-stage renal disease (ESRD) patients, expanding to up to 50 participants, and is intended to support a Biologics License Application (BLA) with the FDA.

MONTGOMERY COUNTY, Md. — Businesses in Maryland’s Montgomery County experienced a surge in investment funding in 2024. Mergers and acquisitions, venture capital and private funding deals totaled $2.9 billion, a 36% increase over 2023’s total of $2.2b. Spanning 106 deals across 96 companies, this surge in mergers and acquisitions, venture capital, and private investment reflects Montgomery County’s continued prominence as a regional economic leader. 

Diverse Industries Driving Growth 

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ROCKVILLE, Md., Jan. 30, 2025 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing solutions to advance the discovery, development and commercialization of next-generation cell therapeutics announced today the acquisition of SeQure Dx, a market leader of on-target and off-target editing assessment services for cell and gene therapies.

This strategic acquisition strengthens MaxCyte’s ability to serve ex vivo and in vivo cell and gene therapy (CGT) developers with an innovative suite of tools and services spanning early R&D through clinical development and commercialization. By integrating SeQure Dx into MaxCyte, Maxcyte will expand its service offerings and leverage its commercial and field application scientist teams to work with developers earlier in their research processes. SeQure Dx is revenue generating and expected to be accretive to MaxCyte’s revenue growth.

For the second year in a row, the BioHealth Capital Region (BHCR) has been ranked as a Top 3 BioCluster Hub by Genetic Engineering and Biotechnology News (GEN). Montgomery County, Maryland, located in the heart of the BHCR, offers unparalleled assets, including proximity to the FDA and NIH, making it a premier destination for biohealth innovation. Adding to its already successful programs, Montgomery County is launching new initiatives to further support biotech success in 2025 and beyond.

Existing programs continue to provide strong support for growing companies. The Executive-in-Residence Program connects entrepreneurs in the County with experienced mentors who guide commercialization strategies and accelerate growth. The SBIR Matching Program helps companies amplify their non-dilutive funding by providing additional resources to build on their Small Business Innovation Research (SBIR) awards. Additionally, the Investor Tax Credit incentivizes private investment in Maryland’s innovative companies, making it more attractive for investors to support local startups.

Building on these efforts, Montgomery County is introducing the Technology Innovation Fund and the Founders Fund, which will provide grants of up to $200,000 and $100,000, respectively. These programs are designed to support commercialization milestones for companies in sectors such as healthtech, life sciences, artificial intelligence, and quantum technologies. Additional incentives like the expanded MOVE program and JOBS grants will make it even easier for companies to establish and grow their presence in the county. Partnerships with the Henry Jackson Foundation and BioHub will further enhance the local ecosystem by creating new opportunities and resources for the biotech sector. Applications for the Technology Innovation and Founders Funds are due by January 31, 2025.

ETC Baltimore, dedicated to elevating Baltimore as a national leader in tech startups, announces the opening of its inaugural ETC Venture Hub at Connect Labs Baltimore in the newly constructed 4MLK Building in the University of Maryland BioPark. This milestone marks a significant step in Baltimore’s efforts to strengthen its ecosystem for life science startups and attract high-potential companies to the city.

The ETC Venture Hub at Connect Labs Baltimore is a dedicated space designed to provide early-stage life science companies with the technology, capital, talent and resources needed to successfully grow and scale. Offering desk space, expert support, and a collaborative community, the hub serves as a launchpad for startups. This is part of ETC’s broader strategy to establish multiple footprints throughout the city. By expanding its reach, ETC aims to create a more inclusive and robust entrepreneurial ecosystem, ensuring innovators in all areas of Baltimore have access to the tools and support they need to thrive.

BALTIMORE, January 28, 2025 – KaloCyte, Inc., a pre-clinical biotech startup company developing a bio-inspired red blood cell substitute called ErythroMer™, announced today that it has been selected to join Blue Knight, a strategic collaboration between the Biomedical Advanced Research and Development Authority ('BARDA') and Johnson & Johnson’s global incubator network, JLABS, supporting early-stage innovation and incubation of science and technologies to improve health security and unlock new approaches to solving health issues.

KaloCyte, a University of Maryland BioPark affiliate, will be a virtual resident within JLABS, a premier life science incubator program. They will keep their laboratories and offices in downtown Baltimore where they collaborate closely with the University of Maryland School of Medicine’s Center for Blood Oxygen Transport & Hemostasis (CBOTH).

LEIDEN, Netherlands, January 28, 2025 / Biotech Newswire / -- MIMETAS, a global leader in human disease modeling, has launched OrganoPlate UniFlow (UF), the first commercially available unidirectional, gravity-driven pumpless flow system for drug discovery and disease research. This innovative platform debuts at SLAS 2025 as a key addition to MIMETAS’ service portfolio.

OrganoPlate UF addresses challenges in traditional flow systems by enabling physiologically accurate tissue models that replicate natural biological conditions. With unidirectional, gravity-driven flow, this system eliminates the need for external pumps, simplifying operation while enhancing model accuracy. Supporting up to 512 chips in a single setup, the technology is ideal for rigorous scientific studies and large-scale screening, accelerating research without compromising biological relevance.

HANOVER, MD, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced the pricing of its “reasonable best efforts” public offering with participation from the Company’s Chief Executive Officer, certain board members, and existing institutional investors of the Company, along with a healthcare focused institutional investor, consisting of 8,050,672 shares of common stock (or pre-funded warrants in lieu thereof) and accompanying Series A warrants to purchase up to 8,050,672 shares of common stock (or pre-funded warrants in lieu thereof) and Series B warrants to purchase up to 4,025,336 shares of common stock at a combined purchase price per share (and accompanying warrants) of $0.615 for the institutional investors and $0.7975 for the Company’s Chief Executive Officer and certain board members.

COLUMBIA, Md., (January 27, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $100,000 investment in ReBokeh through the Pre-Seed Builder Fund, a key program under the Social Impact Funds. This initiative provides early-stage businesses with access to funding and resources designed to support their growth and success.

"Having TEDCO in our corner has been incredibly valuable for ReBokeh,” said Rebecca Rosenberg, CEO of ReBokeh. “As a company that planted its roots in Baltimore, we're both excited and immensely proud to continue being a part of the growing startup scene that calls Maryland home."

FREDERICK, Md., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that it has received written agreement from the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process on the overall design of the Company’s planned Phase 3 AURORA trial for Descartes-08, its lead mRNA cell therapy candidate, in myasthenia gravis (MG). The SPA agreement indicates that the FDA has determined that the proposed trial design is acceptable to support a future Biologics License Application for Descartes-08 in MG, subject to the ultimate outcome of the trial.

In this episode of BioTalk, host Rich Bendis is joined by Amitabh Varshney, Dean of the College of Computer, Mathematical, and Natural Sciences and a Professor of Computer Science at the University of Maryland, College Park. Together, they explore the groundbreaking advancements in artificial intelligence and health computing driven by the University of Maryland (UMD).

Dean Varshney discusses the launch of the Artificial Intelligence Interdisciplinary Institute at Maryland (AIM) earlier this year. He shares insights into the vision behind AIM, the strategic hiring of new faculty, the allocation of seed grants, and the development of academic programs in AI, all solidifying UMD's position as a leader in this rapidly evolving field.

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BALTIMORE, Jan. 24, 2025 /PRNewswire/ -- In two separate procedures, MedStar Health cardiac experts at MedStar Union Memorial Hospital reached new heights in cardiovascular care when they performed the state's and the system's first transcatheter tricuspid valve replacements (TTVR) using a recently FDA-approved valve, to treat life-threatening tricuspid regurgitation. On Jan. 7th, the male and female patients, both in their 80's, received the revolutionary valves delivered via a catheter, foregoing the need for conventional open-heart surgery.

COLUMBIA, Md., Jan. 24, 2025 /PRNewswire/ -- TEDCO, Maryland's economic engine for technology companies, announced nine awardees for the inaugural Maryland Student Venture Showcase and Pava LaPere Innovation Awards. The awards, funded by the State of Maryland through the Pava LaPere Legacy of Innovation Act of 2024, recognize and support outstanding student entrepreneurs from colleges and universities in the Baltimore-Towson-Columbia metropolitan statistical area.

"The Maryland Student Venture Showcase and Pava LaPere Innovation Awards are a testament to the incredible talent and innovation coming out of Maryland's colleges and universities," said Troy LeMaile-Stovall, TEDCO CEO. "We are excited to support these outstanding student entrepreneurs as they work to grow successful businesses."

The 43rd Annual J.P. Morgan Healthcare Conference, held from January 13–16, 2025, in San Francisco, once again brought together industry leaders, investors, and innovators from around the globe. As the largest healthcare investment symposium, the event offered a platform to discuss breakthroughs in cancer, pain management, neurodegenerative diseases, artificial intelligence (AI) in drug development, and strategies for mergers and acquisitions (M&A).

Several of BioHealth Innovation’s (BHI) Entrepreneurs-in-Residence (EIRs) attended, sharing insights and observations from this pivotal event.

Emergent BioSolutions (Gaithersburg, US) has purchased US and Canadian rights to Kloxxado, adding to its opioid overdose treatment portfolio, which includes Narcan. The growing US opioid epidemic (including synthetic fentanyl) and its treatments will provide future growth drivers for Emergent, said Joe Papa, president and CEO of Emergent, at this year’s J.P. Morgan 43rd Annual Healthcare Conference on 15 January.

Papa presented the company’s “turnaround plan” for 2025 at J.P. Morgan. “We are focused on first stabilising the company, then turning it around and ultimately transforming the company,” Papa told the conference. “It’s a multiyear process.”

COLUMBIA, Md., (January 24, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Builder Fund investment in Nostopharma, a musculoskeletal therapeutic platform company focused on treating complications of trauma, orthopedic surgery and rare diseases musculoskeletal sequalae. TEDCO’s Builder Fund operates under the umbrella of Social Impact Funds and not only provides companies with investment funds but also offers various resources, including executive support, mentorship and assorted networking opportunities.

Eight student teams on a mission to make a positive impact on society presented their startup ideas to a panel of expert judges during the Leonsis Family Entrepreneurship Prize “Bark Tank” Pitch Competition on Wednesday, January 22, 2025, at Georgetown University’s McDonough School of Business, taking home $150,000 in prizes. 

Inspired by the pitches, Ted Leonsis (C’77, P’14, ’15), founder, chairman, principal, and chief executive officer of Monumental Sports & Entertainment, and his family increased the competition’s prize pool to $150,000 – furthering the financial impact and growth opportunity for each of the finalists who took the stage. This year’s prize builds on the $5 million gift the Leonsis family provided last year, which ensures the Bark Tank Pitch Competition exists in perpetuity.

ROCKVILLE, Md. and SUZHOU, China, Jan. 23, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (Nasdaq: AAPG) (HKEX: 6855) announced today the pricing of its U.S. initial public offering of 7,325,000 American depositary shares (“ADSs”), at a public offering price of $17.25 per ADS, before underwriting discounts and commissions. Each ADS represents four ordinary shares of Ascentage Pharma. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Ascentage Pharma, are expected to be approximately $126.4 million. In addition, Ascentage Pharma has granted the underwriters a 30-day option to purchase up to an additional 1,098,750 ADSs at the initial public offering price, less underwriting discounts and commissions. The ADSs are expected to begin trading on the Nasdaq Global Market on January 24, 2025, under the ticker “AAPGV” on a “when-issued” basis, and on January 27, 2025, under the ticker symbol “AAPG” for “regular-way” trading. The offering is expected to close on January 28, 2025, subject to customary closing conditions.

BALTIMORE, MD, UNITED STATES, January 21, 2025 /EINPresswire.com/ -- Linshom Medical announced today U.S. Food and Drug Administration, 510(k), clearance of the company’s two-piece, wearable respiratory sensor.

This clearance brings Linshom Medical closer to commercial launch of a product that has proven to provide clinicians 12 minutes advance notice of respiratory decline in an NIH funded clinical study at Ohio State University.

CES2025 once again brought the world’s brightest minds and groundbreaking innovations to Las Vegas. With over 4,500 exhibitors and more than 141,000 attendees, the event showcased technologies poised to shape industries across the globe. Among these, the health and wellness sector, centered at the Venetian Expo Center, stood out as a beacon of innovation. John Reinhart, Entrepreneur-in-Residence (EIR) at BioHealth Innovation (BHI), attended alongside colleagues from the National Institute on Aging (NIA) to explore the transformative field of AgeTech.

AgeTech—focused on enhancing the quality of life for an aging population—has rapidly emerged as a critical area of innovation. With 1 in 4 people currently over the age of 50, and that number projected to rise to 1 in 3 by 2050, the need for solutions that address aging-related challenges is urgent and global. Reinhart’s insights from CES2025 underscored the immense potential of this growing field.

The AgeTech Collaborative from AARP led the way in promoting innovation at CES2025. With its pavilion now in its third year, AARP highlighted the collaborative ecosystem it has built to foster solutions for the 50+ demographic. Boasting 111 investor organizations, 105 business services partners, 68 testbed collaborators, and 177 startups, the growth of the Collaborative has been remarkable. Its programming featured a pitch competition and networking reception, providing a platform for startups to connect and showcase their solutions.

In this episode of BioTalk with Rich Bendis, Dr. Kolaleh Eskandanian, Vice President and Chief Innovation Officer at Children’s National Hospital, discusses her work driving pediatric healthcare innovation. Dr. Eskandanian introduces the BARDA SPARK Accelerator, a groundbreaking initiative focused on advancing medical countermeasures for children, and explains how it aligns with Children’s National’s mission to lead in pediatric healthcare innovation.

She also highlights the unique challenges in developing pediatric medical countermeasures and the importance of partnerships with organizations like Rainbow Babies, Mass General, and others. Additionally, Dr. Eskandanian shares insights into the hospital’s role in fostering innovation through the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) and the Children’s National Research and Innovation Campus.

Join us for an engaging conversation about the future of pediatric healthcare, the opportunities for innovation, and how the SPARK Accelerator is paving the way for advancements that will improve the lives of children worldwide.

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Maryland-based medical device company receives investment from Pre-Seed Builder Fund.

COLUMBIA, Md., (January 20, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a $200,000 Pre-Seed Builder Fund investment in NanoBioFAB. The Pre-Seed Builder Fund invests in and provides executive support to Maryland-based technology companies run by entrepreneurs who demonstrate economic disadvantage.

“We are thankful that TEDCO has been with us throughout our journey,” said Xiaonao Liu, Ph.D., CEO of NanoBioFAB. “The programs, resources and guidance offered through TEDCO have made an enormous impact on our journey towards success. I urge any entrepreneur in Maryland to reach out to TEDCO and learn more about how they can help your business grow.”

AIN becomes the second selected VCLP to support the next generation of technology innovation

COLUMBIA, Md., (January 15, 2025) — TEDCO, Maryland’s economic engine for technology companies, announces the selection of AIN Ventures as one of the early-stage venture capital fund managers supporting the management and investment of up to $10 million in U.S. Department of Treasury State Small Business Credit Initiative (SSBCI) funding.

“As a mission-driven organization, we are excited to work with early-stage entrepreneurs and TEDCO to strengthen Maryland’s innovation ecosystem and support the successful deployment of valuable SSBCI funding,” said Sherman Williams, co-founder and managing partner of AIN Ventures.

By Bethanie Glover, This email address is being protected from spambots. You need JavaScript enabled to view it. January 15, 2025 - The commonwealth’s biotechnology and innovation footprint is expanding, thanks to an award from the state’s GO Virginia economic development program and a close partnership between the University of Virginia and CvilleBioHub.

The award will add a vital business component to the state’s existing biotech ecosystem to bolster the success of high-potential, early-stage life sciences companies.

GO Virginia approved a $14.3 million funding package to three Virginia biotech accelerator organizations in response to a multiregional proposal called “Project VITAL: Virginia Innovations and Technology Advancements in Life Sciences.”

COLLEGE PARK, Md., January 14, 2025--(BUSINESS WIRE)--IonQ (NYSE: IONQ), a leader in the quantum computing and networking industries, today announced a landmark partnership with the University of Maryland and the State of Maryland with the aim to establish Maryland as the "silicon valley" of the quantum computing industry. The proposed initiative will aim to fuel the growing quantum economy of the U.S. capitol region, provide access to IonQ’s cutting-edge quantum technology, and dramatically strengthen Maryland’s workforce with new quantum-focused jobs.

As part of today’s announcement of the "Capital of Quantum" initiative’s goal of catalyzing more than $1 billion in investments towards Maryland becoming the "Capital of Quantum," IonQ intends to anchor a state-of-the-art quantum intelligence campus based at the University of Maryland at College Park.

ROCKVILLE, Md., Jan. 14, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) and Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) today announced a strategic partnership for the development and commercialization of RGX-121 for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome, and RGX-111 for Mucopolysaccharidosis I (MPS I), also known as Hurler syndrome.

Under the terms of the agreement, REGENXBIO will receive $110 million at closing and up to an additional $700 million if certain milestones are achieved, consisting of $40 million in potential development and regulatory milestones and $660 million in potential sales milestones. REGENXBIO will also receive meaningful double-digit royalties on net sales in the U.S. and Asia (collectively, the "Licensed Territory").

GO Virginia, University of Virginia, Manning Family Foundation, and local Economic Development support the three-year project driving life sciences entrepreneurship.

Charlottesville, VA (January 14, 2025) --- The biotechnology and innovation landscape in Virginia is set for significant growth, thanks to a recent award from the state’s GO Virginia economic development program and a strategic partnership between CvilleBioHub and the University of Virginia (UVA).This award will inject a crucial business component into Virginia’s existing biotech ecosystem, bolstering the success of high-potential, early-stage life sciences companies. GO Virginia has allocated a $14.3 million funding package to three biotech organizations across Virginia as part of the multiregional initiative “Project VITAL: Virginia Innovations and Technology Advancements in Life Sciences.”

January 14, 2025 - Vicky Hatch - Osteosarcoma is a type of aggressive bone cancer that most commonly affects children and young adults between the ages of 10 and 20, during times of rapid bone growth. Although rare, it has a significant impact on young people and their families as treatment can require surgery or amputation. The cancer also has the potential to spread to other organs, most commonly the lungs. Because osteosarcoma is so genomically complex, it has been challenging to identify what genetic mutations drive the disease. As a result, there has been little advancement in treatment options over the past 40 years. 

New research, published in the journal Cell, solves the mystery of what drives the genomic rearrangements causing the aggressive development and evolution of osteosarcoma tumours. By analysing the largest collection of whole-genome data from osteosarcoma patients, the researchers identified a new mutation mechanism, called loss-translocation-amplification (LTA) chromothripsis, which is present in approximately 50% of high-grade osteosarcoma cases. 

GAITHERSBURG, Md., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into an agreement to obtain exclusive commercial rights in the U.S. and Canada to Hikma Pharmaceuticals’ KLOXXADO^® (naloxone HCl) Nasal Spray, an 8 mg naloxone agent that is approved for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.¹ This six-year agreement complements and strengthens Emergent’s mission to protect, enhance, and save lives by helping to reduce opioid overdose deaths —providing compelling product options, combined with a commitment to increasing naloxone access, awareness, and education.

Like his fellow Type 1 diabetics, Alec Smith took insulin every day to regulate his blood sugar. Costs to treat his condition topped $1,000 per month, most of that going to insulin, and Alec made the difficult decision to ration his insulin to save money after aging off his mother’s health insurance plan.

Rationing insulin is a delicate process for diabetics. The body’s insulin needs can fluctuate significantly due to changes in diet, exercise, stress, poor sleep, or other medications, and diabetics must constantly monitor their glucose levels even when taking insulin as directed. When a person’s blood sugar gets too high, the body goes into diabetic ketoacidosis, which releases dangerous amounts of acid into the bloodstream and, if left untreated, can result in death — as it unfortunately did for Alec Smith in 2017. His mother, Nicole Smith-Holt, told CBS News, “I think if the price of insulin in 2017 had been $35, Alec would still be alive today.”

NORTH CHICAGO, Ill. and ROCKVILLE, Md., Jan. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced updates to the ABBV-RGX-314 clinical program.

ABBV-RGX-314 in Wet Age-Related Macular Degeneration (wet AMD), Subretinal Delivery
Data from the ATMOSPHERE^® and ASCENT^™ pivotal trials evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet AMD are expected in 2026.

ABBV-RGX-314 in Diabetic Retinopathy (DR), Suprachoroidal Delivery
AbbVie and REGENXBIO will plan a Phase 3 clinical program. The clinical program will utilize the in-office SCS Microinjector^® to deliver gene therapy to the suprachoroidal space of the eye.