Allegro Ophthalmics Licensee AffaMed Therapeutics Receives Phase 3 CTA Approval in China for Risuteganib for the Treatment of Intermediate Dry AMD

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SAN JUAN CAPISTRANO, CA — September 25, 2023 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel mitochondrial stabilizers for the treatment of ocular diseases, today announced that its licensee, AffaMed Therapeutics, has received Clinical Trial Application (CTA) approval from China’s National Medical Products Administration to investigate the safety and efficacy of Risuteganib (Luminate®), a first-in-class, new mechanism of action ophthalmic intravitreal injectable product candidate for the treatment of intermediate dry age-related macular degeneration (AMD). Under the CTA approval, Risuteganib is expected to become the first product in China to enter Phase 3 development for the treatment of dry AMD.

Allegro has a Special Protocol Agreement (SPA) in place with the U.S. Food and Drug Administration (FDA) and also received scientific advice from the European Medicines Agency (EMA) to conduct a Phase 3 dry AMD clinical trial to demonstrate improvement in vision in patients with intermediate dry AMD.

“We congratulate Affamed Therapeutics for achieving this regulatory milestone. This sets the stage for multi-region approval of Risuteganib and availability to patients in need,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC.

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its oxidative stress-stabilizing portfolio, Allegro developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in two ex-U.S. studies in humans. 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.

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Allegro Ophthalmics Receives FDA Agreement Under Special Protocol Assessment (SPA) for Phase 2b/3 Clinical Trial of Risuteganib for the Treatment of Intermediate Dry AMD

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Intermediate Dry AMD Treatment Is a Significant Unmet Need
Mitochondrial Stabilizing Candidate Risuteganib Has Shown Best Corrected Visual Acuity Gains in Dry AMD Patient Population

SAN JUAN CAPISTRANO, CA — April 12, 2023 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel mitochondrial stabilizers for the treatment of ocular diseases, today announced that the Company has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of its Phase 2b/3 clinical trial of risuteganib (Luminate®) for the treatment of intermediate, non-exudative age-related macular degeneration (dry AMD).  Finalization of this assessment indicates that the FDA agrees that critical elements of the overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses) are adequate and acceptable for a study intended to support a future marketing application.

“We are excited that the overall protocol design of our Phase 2b/3 dry AMD clinical trial was finalized by the FDA,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC. “The agreement by the FDA of the SPA provides a clear regulatory path for our first-in-class drug, risuteganib, for the treatment of intermediate dry AMD for an unmet medical need. This is important because dry AMD leads to irreversible, and in many cases catastrophic, vision loss. A therapy to treat this disease is greatly needed.”

The Phase 2b/3 study design is based on Allegro’s successfully completed U.S. Phase 2a study, in which the primary endpoint was the proportion of subjects with a gain of ≥ 8 letters of vision with two risuteganib injections versus one sham treatment. The Phase 2a trial was a prospective, randomized, double masked, placebo-controlled, multi-center U.S. study that evaluated the safety and efficacy of risuteganib in patients with intermediate dry AMD. The primary endpoint was met, with 48 percent of patients in the risuteganib arm at week 28 and 7 percent of patients in the sham group at week 12 gaining ≥ 8 letters from baseline (p=0.013). Risuteganib was found to be safe, with no reported drug related serious adverse events (SAEs). Additional findings that support the visual acuity improvement included improvements in retinal sensitivity (microperimetry) and color vision (Lanthony color test).

The Phase 2b/3a study will evaluate efficacy at 52 weeks and safety through 96 weeks. Patients will receive 5 intravitreal injections (IVTs) 12 weeks apart with continued IVT treatment during the follow-up safety portion of the study. The primary endpoint of the study is the improvement in best corrected visual acuity (BCVA) at 52 weeks in the active risuteganib group vs the sham control group. This study design also includes threshold OCT screening, such as minimum ellipsoid zone and photoreceptor layer thickness, that strongly predicts BCVA response to treatment, thus helping clinicians predict outcomes and select the patients most likely to benefit from treatment.

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its oxidative stress-stabilizing portfolio, Allegro developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in two ex-U.S. studies in humans. 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.

# # #

Allegro Ophthalmics Announces Presentation of Key Data Surrounding Dry AMD Pipeline Candidates, Treatment Considerations

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Intermediate Dry AMD Treatment Highlighted as Significant Unmet Need
Only Mitochondrial Stabilizing Candidates, Including Allegro’s Risuteganib, Have Shown Best Corrected Visual Acuity (BCVA) Gains in this Patient Population

SAN JUAN CAPISTRANO, CA — February 10, 2023 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases, today announced the presentation of key data supporting dry AMD pipeline candidates, including the company’s risuteganib (Luminate®), this morning at Bascom Palmer Eye Institute’s 20th annual Angiogenesis, Exudation and Degeneration meeting, being held virtually February 10-11, 2023.1

Esteemed ophthalmologist and researcher Dr. Baruch Kuppermann*, Roger F. Steinert professor, chair of the Department of Ophthalmology, and director of the Gavin Herbert Eye Institute at the University of California, Irvine, shared clinical evidence as well as considerations for matching mechanism of action (MOA) with the right patient population and stage of disease to reverse vision loss in dry AMD, which affects more than 15 million patients in the United States alone.

During his presentation to an audience of retina specialists, general ophthalmologists and researchers, Dr. Kuppermann highlighted that most Dry AMD pipeline candidates currently focus on treating geographic atrophy (GA), an advanced stage of the disease, which accounts for only 10% of Dry AMD patients, as opposed to those with early and intermediate disease, who make up 40% of the total Dry AMD patient population. The only two pipeline candidates that have shown best corrected visual acuity (BCVA) gains in intermediate dry AMD are mitochondrial stabilizing drugs, including risuteganib. Importantly, Dr. Kuppermann also illustrated how these candidates have shown threshold OCT characteristics, such as minimum ellipsoid zone and photoreceptor layer thickness, that strongly predicts BCVA response to treatment, thus helping clinicians predict outcomes and select the patients most likely to benefit from treatment.

“Existing data suggest that restoration of functional vision is achievable in Dry AMD patients with more anatomical integrity, or less disease progression, using these mitochondrial stabilizing drug candidates,” explained Dr. Kuppermann. “This underscores the potential for early treatment of Dry AMD, with the right therapeutic agent, to reverse vision loss.”

“The Angiogenesis, Exudation and Degeneration meeting is an important forum for the retinal professional community, and we are grateful to Dr. Kuppermann for presenting this compelling information together in a context in which it has not been shared before,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC. “Treatments for Dry AMD remain a significant unmet need, and we believe that, given the evidence and considerations put forth by Dr. Kuppermann, risuteganib has tremendous potential to help address that need.”

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its oxidative stress-stabilizing portfolio, Allegro developed ALG-1007 for topical use in dry eye disease.  ALG-1007 demonstrated promising results in two ex-U.S. studies in humans. 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.

*Dr. Kuppermann is a member of Allegro’s Medical Advisory Board.

# # #

References

  1. Kuppermann B. “Reversing Vision Loss in dry AMD: Matching Mechanism with the Right Patient and Stage of Disease.” Angiogenesis, Exudation and Degeneration Meeting, February 10-11, 2023, online.

Allegro Ophthalmics Announces New Scientific Data to Be Presented During the 2022 ARVO Annual Meeting

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SAN JUAN CAPISTRANO, CA — April 27, 2022 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases, today announced that two scientific posters involving risuteganib, the company’s lead investigational compound in retina, will be presented during the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. ARVO 2022 will be held May 1-4, 2022 in Denver, Colorado.

“We are excited to present these scientific findings that provide deeper insight into risuteganib’s mechanism of action,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC. “In previous studies, risuteganib was shown to protect human RPE cells against oxidative stress-associated cellular dysfunction. At ARVO 2022, we will unveil new research focused on identifying how these processes may occur.”

The schedule of scientific poster presentations is as follows:

About Allegro Ophthalmics, LLC

Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its oxidative stress-stabilizing portfolio, Allegro developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in two ex-U.S. studies in humans. 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.

# # #

U.S. Phase 2 Study Published in OSLI Retina Highlights the Safety and Efficacy of Risuteganib in Patients with Dry Age-Related Macular Degeneration

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SAN JUAN CAPISTRANO, CA — August 3, 2021 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases, today announced that the results of the company’s U.S. Phase 2a risuteganib non-exudative age-related macular degeneration (dry AMD) study are published in Ophthalmic Surgery, Lasers, and Imaging (OSLI) Retina. Entitled “Safety and Efficacy of Intravitreal Risuteganib for Non-Exudative AMD: A Multicenter, Phase 2a, Randomized, Clinical Trial,” this paper describes the treatment effect of risuteganib 1.0 mg in patients with intermediate dry AMD.

The primary endpoint—the proportion of subjects with ≥ 8 letters ETDRS BCVA gain from baseline—was met by 48% of patients in the risuteganib group at week 28 and 7% of patients in the sham group at week 12 (p=0.013). Risuteganib was found to be safe with no reported drug related serious adverse events.

Risuteganib is a small peptide oxidative stress stabilizer that has been shown to protect human RPE cells against oxidative stress-associated cellular dysfunction. These clinical data suggest that risuteganib can reverse vision loss and restore functional vision in patients with intermediate dry AMD with treatment at a 12-week interval.

Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, said, “To our knowledge, this is the first study to use a functional endpoint and demonstrate reversal of vision loss in a study population with intermediate dry AMD, a sight-threatening disease for which there is currently no available therapeutic treatment. These clinical findings in dry AMD complement our extensive preclinical findings and earlier clinical studies that suggested risuteganib could restore visual function.”

David S. Boyer, M.D., Founder, Retina-Vitreous Associates Medical Group and lead author, commented, “Dry AMD patients suffer from progressive vision loss affecting activities of daily living. Having a drug that could restore vision would have tremendous impact on the quality of life of these patients.”

The paper can be accessed from OSLI Retina’s website at https://journals.healio.com/journal/oslir. For more information about this trial, visit www.ClinicalTrials.gov using the number NCT03626636.

About Allegro Ophthalmics, LLC

Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel integrin regulating therapies for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its integrin-regulating portfolio, Allegro has developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in an ex-U.S. proof-of-concept study in humans, and is currently being evaluated in a second and 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.

# # #

Allegro Ophthalmics Announces Positive Results of Vehicle-controlled Ex-U.S. Phase 2 Trial of ALG-1007 for the Treatment of Dry Eye Disease

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Allegro also announces FDA acceptance of IND for ALG-1007 for dry eye disease, clearing path to initiate Phase 2b/3 U.S. study

SAN JUAN CAPISTRANO, CA — July 24, 2021 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases, today announced that all primary and secondary endpoints of an ex-U.S. vehicle-controlled study of ALG-1007 topical eye drop in patients with dry eye disease (DED) were met. The results were presented by Eric D. Donnenfeld, M.D., at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators (ASCRS ASOA) Annual Meeting in Las Vegas.1

The study authors determined ALG-1007, a fixed combination of 0.6% risuteganib and 0.125% sodium hyaluronate in a vehicle solution, demonstrated the highest efficacy among four study arms (p<.001) comprising various combinations of the solution components. No adverse events, ocular irritation, or prolonged blurring of vision were reported in the study. Compared with patients in the control arms, patients who received ALG-1007 experienced statistically significant better results in tear break-up time, inferior corneal staining, and scores on the dry eye management scale and visual analog scales. Statistical significance versus the control was seen as early as 2 weeks.

The company also announced that the U.S. Food and Drug Administration (FDA) accepted the filing of an Investigational New Drug (IND) application for ALG-1007, paving the way for Phase 2b clinical development in the U.S.

“Allegro is happy to share the results of our second ex-U.S. clinical trial, which continue to suggest that ALG-1007 improves the signs and symptoms of dry eye,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics. “These results support the development of a U.S.-based phase 2b/3 study. These data, coupled with the FDA’s acceptance of Allegro’s IND application, will allow investigators to collect more data to elucidate our understanding of how ALG-1007 may provide relief to patients with dry eye, a disease that adversely affects millions of people worldwide.”

“I’m very encouraged by the results of this trial, which demonstrated that ALG-1007 had the most robust improvement in signs and symptoms of dry eye compared to the comparator arms,” said Dr. Donnenfeld, founding partner of Ophthalmic Consultants of Long Island and Clinical Professor of Ophthalmology at NYU. “The components in ALG-1007 appear to have synergistic effects. It should be emphasized that no adverse events, ocular irritation, or prolonged blurred vision were reported in the study—an impressive finding.”

The prospective, randomized, double-masked, vehicle-controlled study was conducted in Armenia. Researchers randomly assigned patients to one of four arms (64 eyes total; 16 eyes per arm): vehicle; vehicle and 0.125% sodium hyaluronate; vehicle and 0.6% risuteganib; and ALG-1007, which contains vehicle, 0.125% sodium hyaluronate, and 0.6% risuteganib. Patients struggling with dry eye signs and symptoms for at least 6 months received 1 drop twice daily for 12 weeks, at which point data were collected and analyzed. Exclusion criteria included history of ocular herpetic keratitis, LASIK surgery, or use of glaucoma medication; any ocular surgery in the past 6 months; and current use of DED therapy.

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 oxidative stress stabilizers for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its oxidative stress-stabilizing portfolio, Allegro developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in two ex-U.S. studies in humans. 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, et al. Prospective, Randomized, Double-Masked, Vehicle- Controlled Study to Evaluate the Safety and Efficacy of Topical Risuteganib (ALG-1007) in the Treatment of Dry Eye Disease. 2021 ASCRS•ASOA.

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Allegro Ophthalmics to Present the Results of ALG-1007 Ex-U.S. Phase 2 Clinical Trial for Dry Eye Disease at the 2021 ASCRS ASOA Annual Meeting

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Marks Allegro’s Second Exploratory Study of ALG-1007 in Dry Eye Disease

SAN JUAN CAPISTRANO, CA — July 19, 2021 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel oxidative stress-stabilizers for the treatment of ocular diseases, today announced that the results of the company’s second ALG-1007 ex-U.S. clinical trial for the treatment of dry eye disease (DED) will be presented during the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators (ASCRS ASOA) Annual Meeting being held July 23-27 in Las Vegas, NV.

On Thursday, July 22, Allegro’s President and CEO, Vicken Karageozian, M.D., will present at EyeceleratorTM during its “Dry Eye: The Need for Innovation” session.  Then, on Saturday, July 24, Eric D. Donnenfeld, M.D., will present full study results of the company’s second ALG-1007 ex-U.S. clinical trial for DED at ASCRS ASOA.

“Allegro is very much looking forward to participating in the first live Eyecelerator meeting and to sharing the results of a randomized, double masked, vehicle-controlled clinical trial of ALG-1007 for the treatment of dry eye disease,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics. “The new data will provide insights into the formulation, efficacy, tolerability, and safety of the experimental topical eye drop ALG-1007 in patients with dry eye disease, and underscores Allegro’s commitment to developing innovative treatments that bring meaningful therapeutic benefits to patients.”

The corporate and scientific presentations are scheduled as follows:

Thursday, July 22: 3:25-4:15 PM
Eyecelerator, Mandalay Bay South Convention Center
Oxidative Stress Stabilizers for the Treatment of Ocular Diseases
Vicken Karageozian, M.D.

Saturday, July 24 1:40-1:45 PM
ASCRS ASOA, Mandalay Bay Convention Center, MBCR-Level 2, Surf EF
Prospective, Randomized, Double-masked, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Topical Risuteganib (ALG-1007) 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 oxidative stress stabilizers for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its oxidative stress-stabilizing portfolio, Allegro has developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in two ex-U.S. studies in humans. 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.

# # #

William J. Link, PhD, Named Chairman of Allegro Ophthalmics’ Board of Directors

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Executive Team Strengthened with the Appointment of Stephanie Yee as Vice President of Finance

SAN JUAN CAPISTRANO, CA — June 22, 2021 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel integrin-regulating therapies for the treatment of ocular diseases, today announced that William J. Link, PhD, has been appointed chairman by the company’s board of directors and that Stephanie Yee was named vice president of finance.

Vicken Karageozian, M.D., president and CEO of Allegro Ophthalmics, said, “I am thrilled that Bill has agreed to serve as our board chairman and pleased to promote Stephanie as VP of finance and member of the executive team. Bill is a pioneer whose vast experience in building and leading successful ophthalmic companies is a tremendous asset at this exciting moment at Allegro. Stephanie has a deep and extensive record in managing the financial operations of a variety of businesses. Their appointments will help to ensure Allegro’s success as we advance our drug candidates—risuteganib for the treatment of intermediate non-exudative age-related macular degeneration (dry AMD) and ALG-1007 for the treatment of dry eye disease—through clinical development.”

Dr. Link is founder and principal of Flying L. Partners and is a founder and managing director of Versant Ventures. Prior to Versant, Dr. Link was a general partner at Brentwood Venture Capital. With more than two decades of operations experience in the healthcare industry, Dr. Link has a proven record of building and managing large, successful medical product companies, including Chiron Vision where he was co-founder, chairman and CEO until it was sold to Bausch + Lomb in 1997. Dr. Link also founded and served as president of American Medical Optics (AMO), a division of American Hospital Supply Corporation, which was sold to Allergan in 1986.

Bringing more than two decades of accounting and finance experience to Allegro, Ms. Yee has held several management roles at ZO Skin Health and ClaripHy Communications, as well as at Emulex Corporation, which was acquired by Avago Technologies and later merged with Broadcom. During her tenure, she became the resident SEC reporting expert and managed due diligence and integration for three acquisitions. Ms. Yee also worked at IntraLase. When IntraLase was acquired by AMO, Ms. Yee coordinated the company’s integration into AMO, now part of Johnson & Johnson.

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel integrin-regulating therapies for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its integrin-regulating portfolio, Allegro has developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in an ex-U.S. proof-of-concept study in humans and is currently being evaluated in a second and 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.

# # #

Allegro Ophthalmics Announces New Scientific Data to Be Presented During the 2021 ARVO Annual Meeting

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SAN JUAN CAPISTRANO, CA — April 27, 2021 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel integrin regulating therapies for the treatment of ocular diseases, today announced that four scientific posters involving risuteganib, the company’s lead investigational compound in retina, will be presented during the 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held virtually May 1-7, 2021.

“It’s exciting to see such a diverse set of preclinical data that explores the retinal protective, anti-inflammatory, and anti-angiogenic properties of risuteganib in in vitro and in vivo models be presented at the largest meeting of eye and vision researchers in the world,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC. “Risuteganib has been shown to protect human RPE cells against oxidative stress-associated cellular dysfunction in previous preclinical studies and restore visual function in early clinical trials. At ARVO, we look forward to presenting data from five independent labs that better explain these visual gains.”

The schedule of scientific poster presentations is as follows:

Yang, P & Jaffe, G et al. “Risuteganib Modulates Multiple Transcription Factors regulated by Hydroquinone in Human RPE Cells.” Saturday, May 1, 2021 from 10:15 a.m. to 12:00 p.m. EDT

Ochoa-de la Paz, L & Quiroz-Mercado, H et al. “Neuroprotective Effect of Risuteganib on Retinal Neurons in an Excitotoxic Injury Cell Culture Model and a Mechanical Injury Rat Model.” Wednesday, May 5, 2021 from 9:00 a.m. to 10:45 a.m. EDT

Chwa, M & Kenney, C et al. “Cell Viability and Transcriptome Changes Associated with Hydrogen Peroxide and Risuteganib Exposure in Human Retinal Cells In Vitro.” Wednesday, May 5, 2021 from 9:00 a.m. to 10:45 a.m. EDT

Shao, Z, Campochiaro, P & Kornfield, J et al. “Suppression of Murine Choroidal and Retinal Neovascularization by Risuteganib and the Accompanying Transcriptome Changes in the OIR Retina.” Wednesday, May 5, 2021 from 2:45 p.m. to 4:30 p.m. EDT

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel integrin regulating therapies for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its integrin-regulating portfolio, Allegro has developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in an ex-U.S. proof-of-concept study in humans, and is currently being evaluated in a second and 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.

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Bausch Health to Acquire Option to Purchase All Ophthalmology Assets of Allegro Ophthalmics

Agreement Includes Global Rights for Risuteganib, An Investigational Treatment Expected to Help Reverse Vision Loss Due to Dry AMD, A Significant Unmet Medical Need

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LAVAL, Quebec, and San Juan Capistrano, Calif., Sept. 21, 2020 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and Bausch + Lomb, its leading global eye health business, and Allegro Ophthalmics, LLC (Allegro), a privately held biopharmaceutical company focused on the development of novel therapies that regulate integrin functions for the treatment of ocular diseases, announced today that Bausch Health (through its affiliate) has entered into an agreement to acquire an option to purchase all ophthalmology assets of Allegro (the “Option”), including global rights for risuteganib (Luminate®)[1], Allegro’s lead investigational compound in retina, which is believed to simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as intermediate dry Age-related Macular Degeneration (AMD).

It is estimated that as many as 16 million people in the United States have AMD[2], and globally, the prevalence of AMD is expected to reach 196 million people worldwide this year and to increase to 288 million by 2040.[3] Approximately 90 percent of people diagnosed with AMD have dry AMD, for which there are currently no treatments.[4]

“As part of the ongoing transformation of Bausch Health, we continue to seek strategic opportunities to build-up our pipeline in core businesses, including Bausch + Lomb, our global eye health business. The addition of the ophthalmic assets of Allegro would significantly enhance our comprehensive portfolio of products for AMD,” said Joseph C. Papa, chairman and CEO of Bausch Health. “If approved, risuteganib may be the first treatment indicated to help reverse vision loss due to dry AMD and would address a significant unmet medical need affecting millions of people globally.”

“Allegro is excited to partner with Bausch Health, an established global player in ophthalmology that values the potential of risuteganib and our integrin-regulating platform as much as we do,” said Vicken Karageozian, M.D., president and CEO, Allegro. “As we prepare for our Phase 3 clinical program, we look forward to working closely with Bausch Health on the united goal of one day being able to offer a treatment option to the millions of people who are currently losing their vision to dry AMD.”

Risuteganib is an investigational integrin-regulating therapy that is believed to reduce mitochondrial dysfunction involved in intermediate dry AMD. By targeting multiple pathways, risuteganib may help reduce the cellular burden of oxidative stress and restore retinal homeostasis.[5]Two concurrent Phase 3 studies evaluating the use of intravitreal risuteganib to treat intermediate dry AMD are expected to begin within the next 12 months.

Other ophthalmology assets of Allegro include ALG-1007, a topical integrin regulator under investigation for the treatment of dry eye disease. It is currently in Phase 2 development outside the United States.

The Option payment totaling $50 million would be made in two tranches, with the first payment of $10 million upon signing. Allegro intends to raise additional funding, following which, Bausch Health will make a second payment of $40 million, which is expected to be made in 2021. If Bausch Health then elects to exercise the Option, additional payments will be payable.

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel integrin-regulating therapies for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro’s lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as intermediate dry AMD. A U.S. Phase 2a study with risuteganib in intermediate dry AMD met its primary endpoint of vision recovery. Expanding its integrin-regulating portfolio, Allegro has developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in an ex-U.S. proof-of-concept study in humans, and is currently being evaluated in a second and larger ex-U.S. Phase 2 study. For more information, visit www.allegroeye.com.

About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on helping people see. Its core businesses include over-the-counter products, dietary supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most comprehensive product portfolios in the industry, which is available in approximately 100 countries. For more information, visit www.bausch.com.

About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com.

Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,”“expects,”“intends,”“plans,”“should,”“could,”“would,”“may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health’s most recent annual report on Form 10-K and detailed from time to time in Bausch Health’s other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

[1]Provisional name. Luminate® is a registered trademark of Allegro Ophthalmics, LLC.
[2]IRi. Raw Buyer Count Comparison Shows the Percent of Households and Individuals with AMD is on the Rise. AMD Buyer Group Analytics. Demographics. March 2018.
[3]Wong et al. “Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis”. The Lancet. Volume 2, No. 2, e106–e116, February 2014.
[4]The Discovery Eye Foundation. Dry AMD. 2014.
[5]Kaiser PK. Topline results from a prospective, double-masked, placebo-controlled phase-2b clinical study evaluating ALG-1001 (Luminate) in patients with diabetic macular edema. ARVO, May 2017.

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