Allegro Ophthalmics Announces Positive Results of Ex-U.S. Proof-of-Concept Trial with Integrin Inhibitor ALG-1007 for Dry Eye Disease

Results of the Trial Suggest that ALG-1007 is Well-Tolerated and Demonstrates a Dose Response with Improvement as Early as Two Weeks

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SAN JUAN CAPISTRANO, CA — May 14, 2019 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel anti-integrin therapies for the treatment of ocular diseases, today announced positive results of an ex-U.S. proof-of-concept clinical trial of the new investigational ALG-1007 topical drop drug candidate in patients with dry eye disease (DED). The results were presented by Eric D. Donnenfeld, M.D., last week at the 2019 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators (ASCRS•ASOA) Annual Meeting in San Diego, CA.1

The ex-U.S. proof-of-concept clinical trial concluded that ALG-1007 demonstrated a dose response, indicating that the active pharmaceutical ingredient (API) in ALG-1007 is effective in improving the signs and symptoms of DED with improvement as early as two weeks. At the highest dose concentration (0.6%), ALG-1007 demonstrated statistically significant efficacy in nearly all assessments and a more rapid onset of action compared to the lowest dose (0.125%). ALG-1007 was well-tolerated with no drug-related adverse events, even at the highest dose, and there was no reported blurring of vision or ocular irritation, even at the time of application.

“Allegro is excited to share our ex-U.S. proof-of-concept data of ALG-1007 for dry eye disease,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics. “These early results suggest that ALG-1007 improves the signs and symptoms of dry eye, a disease that affects millions of people globally, with symptoms that include scratchy, stinging or burning sensations, and pain or redness in the eye. This frequently blurs vision, reading ability, and produces light sensitivity in many patients. Allegro has initiated a second and larger double-masked, vehicle-controlled ex-U.S. Phase 2 clinical trial, results of which are anticipated in the second half of 2019.”

“This early ex-U.S. proof-of-concept data looks promising, especially at the higher 0.6% ALG-1007 dose. My fellow Allegro Cornea SAB members* and I were particularly impressed by how well-tolerated the drug seems to be,” said Dr. Donnenfeld, founding partner of Ophthalmic Consultants of Long Island and Ophthalmic Consultants of Connecticut. “Dry eye is a multifactorial disease and there remain unmet needs for a very large patient population. It will be interesting to see the outcomes of the second, larger ex-U.S. study, which is exploring the drug’s efficacy and safety in even higher concentrations.”

The completed prospective, open-label ex-U.S. proof-of-concept clinical trial enrolled 40 eyes of 21 patients diagnosed with DED for at least six months. Patients were assigned to one of four treatment doses (n=10, each group): 0.125%, 0.25%, 0.4% and 0.6% of ALG-1007 in a lubricating ophthalmic topical solution. Topical treatment was administered as one drop two times per day, and subjects were followed at multiple timepoints for 12 weeks. Outcome measures were tear break-up time (TBUT), SICCA total ocular staining score, corneal and nasal conjunctival staining score, and reported symptoms using the visual analog scale (VAS) symptom index.

*The Allegro Cornea Scientific Advisory Board (SAB) includes Drs. Richard L. Lindstrom, Edward J. Holland and Eric D. Donnenfeld.

All educational content of the ASCRS•ASOA Annual Meeting is planned by its program committee, and ASCRS•ASOA does not endorse, promote, approve, or recommend the use of any products, devices, or services.

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel anti-integrin therapies for the treatment of ocular diseases. Allegro’s lead investigational drug risuteganib (Luminate®) successfully completed two Phase 2 diabetic macular edema (DME) studies and is currently being evaluated in a U.S. Phase 2 intermediate dry age-related macular degeneration (intermediate dry AMD) study. Expanding its anti-integrin portfolio, Allegro has developed ALG-1007, an anti-integrin drug candidate for topical use in DED. ALG-1007 has successfully completed an ex-U.S. proof-of-concept study in humans, and is currently being evaluated in a larger ex-U.S. Phase 2 study. For more information, visit www.allegroeye.com.

Risuteganib (Luminate®) and ALG-1007 are investigational drugs and are not approved for commercial sale.

Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

Source:
1. Donnenfeld E, Holland E, Lindstrom R, Vardanyan A, Adamyan T, Karageozian L, Aubel J, Sarayba M. A Pilot Study to Evaluate the Safety and Exploratory Efficacy of ALG-1007 Topical Ophthalmic Solution for the Treatment of Dry Eye Disease. 2019 ASCRS•ASOA.

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Allegro Ophthalmics to Present the Results of Its ALG-1007 Ex-U.S. Trial for Dry Eye Disease at the 2019 ASCRS•ASOA Annual Meeting

ALG-1007 Marks Allegro’s Second Exploratory Anti-Integrin Drug Candidate—Now,  for the Potential Treatment of Dry Eye Disease

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SAN JUAN CAPISTRANO, CA — April 30, 2019 — Following last week’s news that the company is expanding its pipeline into dry eye and has created a new Cornea Scientific Advisory Board (Cornea SAB), Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel anti-integrin therapies for the treatment of ocular diseases, today announced that the results of its ALG-1007 ex-U.S. proof-of-concept clinical trial for the treatment of dry eye disease (DED) will be presented during the 2019 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators (ASCRS•ASOA) Annual Meeting being held May 3-7 in San Diego, CA.

On Thursday, May 2, Allegro’s President and CEO Vicken Karageozian, M.D., will provide an overview on the company’s vision moving forward into other ocular indications at the Ophthalmology Innovation Summit (OIS). Then on Monday, May 6, Eric D. Donnenfeld, M.D., will present full study results of the ALG-1007 ex-U.S. proof-of-concept clinical trial for DED at ASCRS•ASOA.

The expansion into front-of-the-eye indications bolsters Allegro’s existing anti-integrin portfolio, which includes risuteganib (Luminate®), currently being developed for diabetic macular edema (DME) and intermediate dry age-related macular degeneration (intermediate dry AMD). Pre-clinical and clinical findings of risuteganib convinced the company that it could develop a new anti-integrin compound to treat DED.

“Allegro is excited to share, for the first time, our ex-U.S. proof-of-concept data with the clinical community at ASCRS and OIS,” said Dr. Karageozian. “Allegro is continuously exploring new ways to apply our anti-integrin portfolio to help improve patients’ vision, and ALG-1007 represents our first exploratory drug for the potential treatment of dry eye, a disease that adversely affects millions of Americans.”

The corporate and scientific presentations are scheduled as follows:

Thursday, May 2: 9:45-9:51 AM
Ophthalmology Innovation Summit, Hilton San Diego Bayfront
Addressing the Unmet Need of Ocular Diseases with a Novel Anti-Integrin Portfolio.
Vicken Karageozian, M.D.

Monday, May 6: 1:45-1:50 AM
San Diego Convention Center, Room 1B
A Pilot Study to Evaluate the Safety and Exploratory Efficacy of ALG-1007 Topical Ophthalmic Solution for the Treatment of Dry Eye Disease. Eric D. Donnenfeld, M.D.

All educational content of the ASCRS•ASOA Annual Meeting is planned by its program committee, and ASCRS•ASOA does not endorse, promote, approve, or recommend the use of any products, devices, or services.

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel anti-integrin therapies for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational anti-integrin compound in retina, simultaneously acts on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as DME and intermediate dry AMD. Risuteganib successfully completed two Phase 2 DME studies and is currently being evaluated in a U.S. Phase 2 intermediate dry AMD study. Expanding its anti-integrin portfolio, Allegro has developed ALG-1007, an anti-integrin drug candidate for topical use in DED. ALG-1007 has successfully completed an ex-U.S. proof-of-concept study in humans, and is currently being evaluated in a larger ex-U.S. Phase 2 study. For more information, visit www.allegroeye.com.

Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

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Allegro Ophthalmics Expands Its Anti-Integrin Portfolio with New Front-of-the-Eye Drug Candidate ALG-1007 for the Treatment of Dry Eye Disease

Richard L. Lindstrom, M.D., Edward J. Holland, M.D., and Eric D. Donnenfeld, M.D., Join Allegro’s Newly-Formed Cornea Scientific Advisory Board

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SAN JUAN CAPISTRANO, CA — April 25, 2019 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel anti-integrin therapies for the treatment of ocular diseases, today announced the expansion of the company’s anti-integrin portfolio with the new front-of-the-eye-drug candidate ALG-1007. ALG-1007 is a topical treatment in development for potential use in patients with dry eye disease (DED), a condition affecting millions of people in the United States.

ALG-1007 bolsters Allegro’s existing anti-integrin portfolio, which includes risuteganib (Luminate®), currently being developed for diabetic macular edema (DME) and intermediate dry age-related macular degeneration (intermediate dry AMD). Pre-clinical and clinical findings of risuteganib convinced the company that it could develop a new anti-integrin compound to treat DED.

Allegro also announced that world-renowned clinicians Richard L. Lindstrom, M.D., Edward J. Holland, M.D., and Eric D. Donnenfeld, M.D., have joined the company’s newly formed Cornea Scientific Advisory Board (Cornea SAB) to provide strategy and direction on Allegro’s clinical development pipeline in the areas of corneal disease and dry eye. Dr. Lindstrom will serve as Chairperson of the Cornea SAB.

“While we remain focused on and committed to our retina portfolio, we at Allegro are continuously exploring new ways to apply our anti-integrin assets to help improve patients’ vision,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics. “ALG-1007 represents Allegro’s first exploratory drug beyond the retina. We recognize the need to bring in independent external expertise that complements our company’s strengths and are thrilled to have such an outstanding group of advisors as Drs. Lindstrom, Holland and Donnenfeld help shape and accelerate our clinical program for dry eye disease.”

“While there are a number of good therapies for dry eye disease, this is a multifactorial disease and there remain unmet needs,” said Dr. Lindstrom. “I am enthusiastic about the early ex-U.S. proof-of- concept data that I’ve seen and look forward to working with my colleagues Drs. Donnenfeld and Holland, who share my enthusiasm, in helping Allegro drive the next phase of this drug candidate forward.”

Dr. Lindstrom is the founder and attending surgeon of Minnesota Eye Consultants, Adjunct Professor Emeritus at the University of Minnesota Department of Ophthalmology, and an internationally- recognized leader in corneal, cataract, refractive and laser surgery. Dr. Holland is the director of Cornea Services at Cincinnati Eye Institute, Professor of Ophthalmology at the University of Cincinnati, and has an international reputation for his knowledge and expertise in the field of cornea and external disease. A well-respected refractive cataract surgery pioneer and LASIK eye surgeon, Dr. Donnenfeld is a founding partner of Ophthalmic Consultants of Long Island and Ophthalmic Consultants of Connecticut. He is also the National Medical Director for TLC Laser Eye Centers, the Surgical Director of the Lions Eye Bank of Long Island, and a Clinical Professor of Ophthalmology at New York University Medical Center.

Drs. Lindstrom, Holland and Donnenfeld are board-certified ophthalmologists who have been at the forefront of ophthalmology throughout their careers, as recognized researchers, teachers, inventors, writers, lecturers and highly acclaimed physicians and surgeons. They have served as board members for companies developing many of the breakthrough ophthalmic technologies of the past two decades.

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel anti-integrin therapies for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational anti-integrin compound in retina, simultaneously acts on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as DME and intermediate dry AMD. Risuteganib successfully completed two Phase 2 DME studies and is currently being evaluated in a U.S. Phase 2 intermediate dry AMD study. Expanding its anti-integrin portfolio, Allegro has developed ALG-1007, an anti-integrin drug candidate for topical use in DED. ALG-1007 has successfully completed an ex-U.S. proof-of-concept study in humans, and is currently being evaluated in a larger ex-U.S. Phase 2 study. For more information, visit www.allegroeye.com.

Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

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Allegro Ophthalmics Appoints Marc Carlson and Rebecca Colbert to the Company’s Board of Directors

New Members Bring Extensive Commercial and Financial Expertise from Private and Public Companies

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SAN JUAN CAPISTRANO, CA — April 9, 2019 —Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel anti-integrin therapies for the treatment of ocular diseases, today announced that two new independent members—Marc Carlson and Rebecca Colbert—have been appointed to the Company’s Board of Directors with Ms. Colbert serving as Chairperson of the Board’s Audit Committee. Bringing extensive executive level commercial and financial leadership experience from both private and public companies, Mr. Carlson and Ms. Colbert will help lead the company’s strategy and direction as it expands its anti-integrin portfolio into new ocular therapeutic areas.

“We are thrilled to welcome Marc and Rebecca to Allegro’s Board. They bring a tremendous amount of strategic leadership experience across a variety of industries at both large and small companies. Marc and Rebecca join an already stellar board that also includes Bill Link and Ron Kurtz, who are among the world’s most influential ophthalmic innovators. Together, their diverse expertise will serve our company extremely well as we continue to advance our current retina programs as well as clinical programs in new ocular therapeutic areas,” said Vicken Karageozian, M.D., President & CEO, Allegro Ophthalmics.

Mr. Carlson brings more than 35 years of experience commercializing products in a variety of industries and creating value for shareholders. Formerly chief customer officer of DocuSign, Mr. Carlson’s expertise helped DocuSign navigate a crowded marketplace and emerge as a leader in its space. His relentless focus on providing measurable value to customers and shareholders alike as well as his ability to develop creative growth stories and global brands were instrumental in the commercial growth of DocuSign from a $50 million private company to a public company with a nearly $10 billion market capitalization over a period of seven years.

“As someone who has personally seen the impact of Luminate with my own eyes, I am excited to help Allegro build a global ophthalmic company that brings to market innovative products that make marked improvements in patients’ visual function,” said Mr. Carlson.

Currently chief financial officer at Vertos Medical, Inc., Ms. Colbert has more than 15 years of experience working in senior level positions for medical device companies, including in her role as vice president, customer and sales operations, U.S. Surgical at Bausch + Lomb before joining Vertos. As vice president of finance at eyeonics, Inc., Ms. Colbert played a significant role in the company’s filing for its initial public offering and ultimate sale to Bausch + Lomb. She began her career at Deloitte as a certified public accountant.

“I am very pleased to join Allegro’s board at this critical time of growth and development,” said Ms. Colbert. “The mounting evidence behind the current portfolio is compelling, and I am enthusiastic about the potential for expansion beyond current applications. Allegro has assembled an impressive team consisting of management, board members and esteemed ophthalmic opinion leaders, and I look forward to working with them to achieve the company’s objectives.”

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel anti-integrin therapies for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational anti-integrin compound in retina, simultaneously acts on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as diabetic macular edema (DME) and intermediate dry age-related macular degeneration (intermediate dry AMD). Risuteganib successfully completed two Phase 2 DME studies and is currently being evaluated in a US Phase 2 intermediate dry AMD study. Allegro is preparing to expand its anti-integrin portfolio into new ocular therapeutic areas. For more information, visit www.allegroeye.com.

Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

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Allegro Ophthalmics Prepares To Take Lead Compound Risuteganib To Phase 3, Appoints New CEO

Hampar Karageozian, Co-Founder and Former CEO, Named Executive Chairman

Vicken Karageozian, MD, Co-Founder and Former President and CMO, Named President and CEO

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SAN JUAN CAPISTRANO, CA — August 21, 2018 —Allegro Ophthalmics, LLC, a late stage ophthalmic biopharmaceutical company focused on the development of therapies to treat retinal diseases, today announced that its Board of Directors has named Hampar Karageozian to the position of Executive Chairman and has appointed Vicken Karageozian, MD, to the position of President and Chief Executive Officer. In his new role, Dr. Karageozian will prepare the company for the next key milestone—entering Phase 3 clinical trials with its lead compound risuteganib (Luminate®) in diabetic macular edema (DME)—and continue developing risuteganib for other retinal disease indications.

“I would like to thank Hampar for his passion, dedication and the effort he has put forth the last seven years in the development of a potential first-in-class drug for the treatment of DME. His many years in drug discovery, and long track record of building successful ophthalmic companies have been essential for establishing a strong foundation for Allegro’s growth,” said William J. Link, PhD, co-founder and managing director of Versant Ventures and member of Allegro’s Board of Directors. “I am convinced that Vicken’s strategic vision, clinical development expertise and experience working with private and institutional investors will position Allegro for future success.”

In his new role as Executive Chairman, Mr. Karageozian will continue to drive Allegro’s strategic vision, focusing on new product discovery, research and development. “Vicken is a passionate leader focused on preparing the company for an important new milestone in its history,” said Mr. Karageozian. “The Board and I are confident that with Vicken and his experienced management team, Allegro is well-positioned to bring risuteganib to market and provide a potential new treatment option for those patients with retinal diseases who respond poorly to the current standard of care.”

“One of my primary objectives will be to reach the completion of Phase 3 clinical trials in DME,” said Dr. Karageozian. “I look forward to working diligently to reach our goals so that doctors and patients will be able to realize the promise of our novel integrin inhibition therapy, risuteganib.”

Dr. Karageozian has more than 25 years’ experience building, leading, and raising capital for companies in the ophthalmic pharmaceutical space. An ophthalmic surgeon by training and prior managing partner of Clarity Eye Group, Dr. Karageozian is the co-founder of three ophthalmic biotech companies, including ISTA Pharmaceuticals, Inc., Vitreoretinal Technologies, Inc., and Allegro. He is the inventor or co-inventor of numerous ophthalmic products with 82 patents issued or pending primarily on drug discoveries. In addition, Dr. Karageozianhas been instrumental in raising more than $200M in venture and institutional capital, corporate partnerships, and regional licenses. 

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a late-stage ophthalmic biopharmaceutical company focused on redefining the retina space with integrin inhibition therapy, a potential market-disrupting class of drugs for the treatment of retinal diseases. Allegro’s lead investigational drug, risuteganib (Luminate®), a broad-spectrum integrin inhibitor, downregulates oxidative stress upstream, at its source, simultaneously affecting all four pathways of oxidative stress that contribute to retinal diseases such as diabetic macular edema (DME) and nonexudative age-related macular degeneration (dry AMD).

Risuteganib has successfully met the endpoints for three Phase 2 studies and is preparing to enter Phase 3 studies in DME during the first half of 2019. Allegro is working closely with the global retina community to bring to market new treatment options for leading causes of blindness and is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. Allegro maintains all intellectual property related to risuteganib worldwide and all commercial rights of risuteganib outside of Japan, Korea and China. For more information, visit www.allegroeye.com.

Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

 

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2018

ISOPT Clinical 2018
Randomized, Prospective, Double-Masked, Controlled Phase 2b Trial to Evaluate the Safety and Efficacy of ALG-1001 (Luminate) in DME

Presented by Baruch D. Kuppermann, MD, PhD
March 1, 2018
Tel-Aviv, Israel

Angiogenesis, Exudation, and Degeneration 2018
Integrin Antagonism and Diabetic Macular Edema

Presented by Peter K. Kaiser, MD
February 10, 2018
Miami, FL

Hawaiian Eye & Retina 2018
Prospective, Double-Masked, Placebo-Controlled Phase 2b Trial on the Safety and Efficacy of ALG-1001 (Luminate) in DME

Presented by Peter K. Kaiser, MD
January 17, 2018
Maui, Hawaii