PHARMA TECH

Eyenovia Announces $15 Million Credit Facility with Avenue Venture Debt Fund

Eyenovia, Inc. | November 30, 2022 | Read time : 02:00 min

Eyenovia Announces
Eyenovia, Inc. a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, announced that the company has entered into a $15 million credit facility with the Avenue Venture Opportunities Fund, L.P. The financing is intended to support manufacturing in anticipation of a MydCombi launch and clinical supply for ongoing programs.

Per the terms of the agreement, Eyenovia received $10 million of gross proceeds at closing. The additional $5 million will be available, at the company’s option, should MydCombi™ be approved for marketing in the U.S. by the Food and Drug Administration by August 2023. The Avenue facility replaces the company’s Silicon Valley Bank facility, which was recently paid off.

We are pleased to have the support of Avenue through this credit facility at terms which create minimal dilution as compared to a traditional equity capital raise. Together with our existing cash on-hand, we expect the additional capital provided by this facility to fund our operations through at least late 2023 or early 2024, or through value creating milestones, including the potential approval of MydCombi™ and preparations for the possible submission of a New Drug Application for our novel presbyopia treatment, MicroLine™.”

Michael Rowe, chief executive officer of Eyenovia

“We are pleased to provide this financing to Eyenovia as we believe its Optejet dispensing technology truly differentiates the company from its peers and offers great potential across a broad range of high value ophthalmic indications,” stated Chad Norman, Senior Portfolio Manager of the Avenue Venture Debt Fund.

Eyenovia’s current pro-forma unrestricted cash balance, including approximately $9.5 million of net proceeds from this facility, is approximately $25.5 million.   

About Eyenovia, Inc.
Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. 

About Avenue Venture Opportunities
The Avenue Venture Debt Fund seeks to provide creative financing solutions to high-growth, venture capital-backed technology and life science companies. The Avenue Venture Debt Opportunities Fund focuses generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt fund is part of the larger group of funds of Avenue Capital Group.  For additional information on Avenue Capital Group, which is a global investment firm with assets estimated to be approximately $12.3 billion as of October 31, 2022.

Spotlight

Capsule dosage form is a new dosage form developed after tablets, injections, oral liquids, etc. It is divided into hard capsules and soft gel capsule.

Spotlight

Capsule dosage form is a new dosage form developed after tablets, injections, oral liquids, etc. It is divided into hard capsules and soft gel capsule.

Related News

BUSINESS INSIGHTS, PHARMACY MARKET

Visiox Pharma Announces FDA Acceptance of New Drug Application for Glaucoma

Visiox Pharma LLC | December 09, 2022

Visiox Pharma, LLC., a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic drugs to address highly prevalent diseases in need of new treatment options, today announced that it has received notification from the U.S. Food and Drug Administration that the agency has completed its filing review and accepted for filing the New Drug Application for PDP-716 for the treatment of glaucoma. The FDA has assigned a Prescription Drug User Fee Act target action date of August 4, 2023. "The NDA acceptance for filing is an exciting milestone and an important next step towards the planned approval and commercial launch of PDP-716. If approved, Visiox has the potential to bring the first once-daily brimonidine to market for the treatment of glaucoma to patients and eye care professionals." Ryan Bleeks, Chief Executive Officer About Visiox Visiox is a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options. Each day is an opportunity for us to disrupt and revolutionize the current market to maximize patient and physician satisfaction. As an agile business partner, we will achieve this through a high level of collaboration with all eye care professionals. Visiox plans to soon submit a second New Drug Application for SDN-037 to the U.S. FDA to address an unmet need for cataract surgery. SDN-037 is a twice daily topical difluprednate corticosteroid utilizing patented TJMTM proprietary formulation. The novel technology provides powerful post-surgical control of inflammation in a clear solution enabling convenient dosing with a proven active ingredient. Cataract extraction is the most frequently performed eye surgery in the U.S. It accounts for 70% of all ocular surgeries. 50 million people are projected to have cataracts in the U.S. by 20501. PDP-716, SDN-037, and TearActTM delivery technology were licensed by Visiox from Sun Pharma Advanced Research Company Ltd.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

AEON Biopharma to Become Publicly Listed via Merger with Priveterra Acquisition Corp.; Accelerating Clinical Development of ABP-450

AEON Biopharma | December 14, 2022

AEON Biopharma, Inc. a private clinical-stage biopharmaceutical company focused on the development of its proprietary botulinum toxin complex ABP-450 injection for therapeutic indications, and Priveterra Acquisition Corp. a special purpose acquisition company announced that they have entered into a definitive business combination agreement. Upon closing of the proposed transaction, the combined company will operate as AEON Biopharma, Inc. and is expected to list on Nasdaq under the ticker symbol AEON Uniquely Positioned to Capitalize on Global Therapeutic Neurotoxin Opportunity Since its founding in 2019, AEON Biopharma has been led by Marc Forth, an Allergan plc veteran of 16 years and a former head of the BOTOX® Therapeutic franchise in the United States. AEON has assembled a seasoned team with expertise in neuroscience research, development, regulatory affairs, operations, manufacturing, and commercialization. Its executive team is comprised of industry leaders who have led new drug FDA approvals including multiple indications across multiple neurotoxin products. The global therapeutic neurotoxin market is currently estimated to be $3.0 billion, of which the U.S. represents approximately 84%, and projected to grow to approximately $4.4 billion in 2027. BOTOX®, marketed by Abbvie, Inc., currently holds approximately 95% U.S. market share for therapeutic indications in the neurotoxin space.1 Other neurotoxin competitors have had success with aesthetic indications in the cash-pay consumer-driven market but have been unable to acquire meaningful market share for therapeutic indications due to the indirect influence of pricing dynamics for aesthetic indications that results in a minimal value proposition for both payors and providers. AEON intends to file a unique BLA for therapeutic indications that would be free of any effects on reimbursement that exist for all other toxin competitors that have both therapeutic and aesthetic indications approved under a single BLA. Lead product candidate, ABP-450, is the same botulinum toxin approved and marketed for an aesthetic indication. Its 900 kDa molecular weight, similar to the market leader, will enable providers with a seamless transition to ABP-450 for therapeutic uses. Similar to the approved neurotoxins currently in the market, ABP-450’s commercial success does not depend upon patent protection, creating the possibility for an annuity-like construct of continued revenue generation, should ABP-450 be FDA approved. AEON’s therapeutic-only focus also provides a differentiated business model designed to deliver enhanced value to payors and providers by permitting a traditional pharma pricing model that is not currently available to competitors that also market their products for aesthetic uses approved under a single BLA. The sole focus on therapeutics allows AEON to pursue an original BLA filing that would allow a unique commercial strategy that cannot be employed by other competitors. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing ABP-450 injection for the treatment of debilitating medical conditions with an initial focus on the neurology and gastroenterology markets. The Company is dedicated to innovation in the rapidly expanding therapeutic botulinum toxin market and believes its therapeutic-only focus will allow AEON to advance safe and effective treatment options to patients, while delivering differentiated economics to payors and physicians. The Company continues to evaluate additional therapeutic indications for development based on a comprehensive product assessment process designed to identify those indications where it believes ABP-450 can attain clinical, regulatory, and commercial success. About Priveterra Acquisition Corp. Priveterra Acquisition Corp. is a blank-check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses in life sciences. Priveterra is sponsored by Robert Palmisano and Priveterra Capital, LLC.

Read More

BUSINESS INSIGHTS, PHARMA TECH

Elligo Introduces AI-Driven Clinical Research Study Technology to Expedite Trials

Elligo Health Research | January 25, 2023

On January 24, 2023, Elligo Health Research®, the leading healthcare-enabling research organization, presented the DataAI Connect, a new data and technology platform that will facilitate data-driven, rapid clinical research. DataAI Connect, a scalable, end-to-end data platform, optimizes the clinical research workflow by decreasing human error and rapidly digesting patient data to speed up clinical studies. Elligo has created an industry-first AI-driven platform that sources, processes, analyses, and distributes patient real-world data (RWD) by bringing together data, processes, and clinical expertise. That means an end-to-end solution that solves clinical trial issues directly rather than being an add-on technology. The platform is adaptable and reusable, and it includes the following An RWD repository of electronic health records (EHRs) and clinical data storage that incorporates EHR, clinical trial, and patient data for analytics, artificial intelligence (AI), and research A comprehensive medical records retrieval and analytics solution that transforms data into searchable, actionable insights and personalized patient journey information within minutes using NLP, ML, and clinical experience. A data-driven protocol development service that puts designs to the test in the real world. Elligo's Chief Data Officer, Michael Ibara, commented, "The application of AI approaches to healthcare and clinical study data is moving from the moon-shot approach to more practical applications." He added, "An example of this approach is the process of getting patients' medical records, which involves manual, non-scalable activities such as getting accurate information on patients' providers, asking sites to track down records, and having humans triage hundreds of pages of medical records. The judicious and intelligent application of natural language processing (NLP), machine learning (ML), and other AI approaches increases speed, accuracy and quality, while removing the burden from the sites and patients." (Source – Business Wire) About Elligo Health Research Founded in 2016, Elligo Health Research® is a leading healthcare-enabling clinical research organization. With access to known patients and their HIPAA-compliant healthcare data, its IntElligo® Research Stack technology and eSolutions Research Accelerator PatientSelect approach expedite clinical trials through healthcare. Elligo's Site Solutions, combined with the largest Known Patient Access Network, enable healthcare practices and research sites to engage in clinical studies. Its services expedite the development of novel pharmaceutical, biotechnology, medical device, and diagnostic products through the adaptive involvement of known patients and clinicians.

Read More