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

Download the PDF

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

Download the PDF

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.

# # #

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

Download the PDF

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

Download the PDF

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

Download the PDF

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.

# # #

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

Download the PDF

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.

# # #

Allegro Ophthalmics to Present Clinical Research on the Company’s Novel Integrin-Regulating Portfolio at the American Academy of Ophthalmology Annual Meeting

AAO 2019 To Feature Multiple Presentations by Leading Experts on Allegro’s Dry Age-Related Macular Degeneration and Dry Eye Disease Assets

Download the PDF

SAN JUAN CAPISTRANO, CA — October 8, 2019 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel therapies that regulate select integrin functions for the treatment of ocular diseases, today announced that the results of its US Phase 2 clinical study of risuteganib (Luminate®) for the treatment of intermediate nonexudative age-related macular degeneration (dry AMD) will be presented during AAO 2019, the American Academy of Ophthalmology’s 123rd annual meeting that is being held October 11- 15 in San Francisco, CA.

On Thursday, October 10, Allegro’s President and CEO Vicken Karageozian, M.D., will provide an overview on the company’s portfolio of integrin-regulating therapies for dry AMD and dry eye disease at the Ophthalmology Innovation Summit (OIS). On Friday, October 11 during Retina Subspecialty Day, David S. Boyer, M.D., will present the primary visual acuity results of the risuteganib US Phase 2 clinical trial for intermediate dry AMD at AAO 2019. An ePoster authored by Glenn J. Jaffe, M.D., on the same study also will be available for viewing.

In June, Allegro announced topline results of its first Phase 2a intermediate dry AMD clinical trial in 45 study subjects. This is the first study to demonstrate reversal of vision loss in dry AMD. The study met its primary endpoint with 48 percent of patients in the risuteganib arm at week 28 gaining ≥ 8 letters from baseline, compared to 7 percent of patients in the sham group at week 12 (p=0.013). Risuteganib was found to be safe with no drug related serious adverse events (SAEs). In addition to best corrected visual acuity (BCVA), secondary outcomes for several patient cases will be presented at AAO 2019.

In addition to the risuteganib Phase 2 intermediate dry AMD data, on Monday, October 14, Richard L. Lindstrom, M.D., will present the results of its ALG-1007 ex-U.S. proof-of-concept trial for the treatment of dry eye disease.

“We are excited to present the progress of our portfolio of integrin-regulating drug candidates to the clinical community at AAO 2019 and OIS,” said Dr. Karageozian. “We recently presented the clinical outcomes of our risuteganib Phase 2a intermediate dry AMD trial to the FDA and I’m pleased to report that Allegro has a clear path forward. We are now working closely with our scientific advisory board to prepare for a larger US Phase 2b/3 trial. In addition, we continue to advance our ALG-1007 dry eye program.”

The corporate and scientific presentations are scheduled as follows:

Thursday, October 10: 8:54-9:01 AM
Ophthalmology Innovation Summit, Hilton San Francisco Union Square
A Novel Integrin-Regulating Portfoliofor Front and Back of the Eye Diseases
Vicken Karageozian, M.D.

Friday, October 11: 4:42-4:47 PM
AAO 2019, Moscone Center, West 3002, San Francisco
Primary Results from Phase 2 Study of Risuteganib (RSG) in Intermediate Dry Age-Related Macular Degeneration (dAMD)
David S. Boyer, M.D.

Monday, October 14: 1:15-1:45 PM
AAO 2019, Moscone Center, Station 3, San Francisco (ePoster Discussion)
A Pilot Study to Evaluate the Safety and Exploratory Efficacy of ALG-1007 Topical Ophthalmic Solution for the Treatment of Dry Eye Disease
Richard L. Lindstrom, M.D.

AAO 2019, Moscone Center, San Francisco (ePoster)
Safety and Efficacy of Risuteganib in Non-Exudative Age-Related Macular Degeneration
Glenn J. Jaffe, M.D.

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, simultaneously acts on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as intermediate dry AMD and diabetic macular edema (DME). A U.S. Phase 2a study with risuteganib in intermediate dry AMD was recently completed. Two Phase 2 DME studies also have been successfully completed. Expanding its integrin-regulating portfolio, Allegro has developed ALG-1007, an integrin-regulating drug candidate for topical use in dry eye disease. 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.

# # #

Allegro Ophthalmics to Present the Results of Its Phase 2 Risuteganib Intermediate Dry Age-Related Macular Degeneration Study at the 19th EURETINA Congress and The Retina Society 2019 Annual Meeting

Results of Allegro’s Ex-U.S. Proof-of-Concept Trial with Integrin Regulator ALG-1007 for
Dry Eye Disease Will Be Presented at the 37th Congress of the ESCRS

Download the PDF

SAN JUAN CAPISTRANO, CA — September 3, 2019 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel therapies that regulate select integrin functions for the treatment of ocular diseases, today announced that the results of its U.S. Phase 2 study evaluating risuteganib (Luminate®) for the treatment of intermediate nonexudative age-related macular degeneration (dry AMD) will be presented during the 19th European Society of Retina Specialists (EURETINA) Congress that is being held September 5-8 in Paris, France and at The Retina Society 2019 Annual Meeting, which is being held September 11-15 in London, UK.

In June, Allegro announced topline results of the risuteganib Phase 2 intermediate dry AMD clinical trial, which met its primary endpoint with 48 percent of patients in the risuteganib arm at week 28 gaining ≥ 8 letters in visual acuity from baseline, compared to 7 percent 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 (SAEs). In addition to complete best corrected visual acuity (BCVA) data, secondary outcomes for several patient cases will be presented at EURETINA and The Retina Society meeting.

Today, Allegro also 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 37th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS), which is being held September 14-18 in Paris, France. ALG-1007, a topical drop, is the company’s second exploratory integrin-regulating drug candidate. In May, Allegro announced that the ex-U.S. proof-of-concept clinical trial concluded that ALG- 1007 was well-tolerated and demonstrated a dose-response with improvement of the signs and symptoms of DED as early as two weeks.

“Allegro is excited to present for the very first time the results of our risuteganib Phase 2 intermediate dry AMD trial as well as those of our ALG-1007 ex-US proof-of-concept DED study to the European ophthalmic community,” said Vicken Karageozian, MD, president and CEO, Allegro Ophthalmics, LLC. “It is encouraging to see such visual acuity gains in patients with dry AMD, a sight-threatening disease for which there is currently no available treatment. In addition, the early positive results of the ALG-1007 proof-of-concept study for dry eye disease, which impacts millions of people across the globe, appear promising.”

The scientific presentations are scheduled as follows:

Sunday, September 8: 9:30-9:36 AM
EURETINA, Palais des Congrès, Paris, France (Amphithéâtre Havane)
Safety and Efficacy of Risuteganib in Non Exudative Age-Related Macular Degeneration: Primary Results from a Phase 2 Study
Peter K. Kaiser, M.D.

Thursday, September 12: 2:44-2:50 PM
The Retina Society 2019 Annual Meeting, The Landmark London, London, UK (Grand Ballroom)
Safety and Efficacy of Risuteganib in Intermediate Non-exudative (Dry) Age-Related Macular Degeneration (AMD): Primary Results from a Phase 2 Study
David S. Boyer, M.D.

Monday, September 16: 9:48-9:54 AM
ESCRS, Paris Expo, Porte de Versailles, Paris, France (Free Paper Forum: Podium 2)
Safety and Efficacy of a Novel Integrin Inhibitor ALG-1007 Topical Ophthalmic Solution for the Treatment of Dry Eye Disease
Eric Donnenfeld, M.D.

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, simultaneously acts on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as intermediate dry AMD and diabetic macular edema (DME). Risuteganib recently successfully completed a U.S. Phase 2 intermediate dry AMD study and also successfully completed two Phase 2 DME studies. Expanding its integrin-regulating portfolio, Allegro has developed ALG-1007, an integrin-regulating drug candidate for topical use in dry eye disease. 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.

###

Allegro Ophthalmics to Present for the First Time the Results of Its Phase 2 Risuteganib Intermediate Dry Age-Related Macular Degeneration Study at the ASRS Annual Meeting 2019

Risuteganib Met Visual Acuity Primary Endpoint with Statistical Significance in U.S. Phase 2 Trial

Download the PDF

SAN JUAN CAPISTRANO, CA — July 24, 2019 — Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel therapies that regulate select integrin functions for the treatment of ocular diseases, today announced that the results of its US Phase 2 study evaluating risuteganib (Luminate®) for the treatment of intermediate nonexudative age-related macular degeneration (dry AMD) will be presented during the American Society of Retina Specialists (ASRS) Annual Meeting 2019 that is being held July 26-30 in Chicago, IL.

On Thursday, July 25, Allegro’s President and CEO Vicken Karageozian, M.D., will provide an overview on the company’s portfolio of integrin-regulating therapies for ocular diseases at the Ophthalmology Innovation Summit (OIS). Then on Saturday, July 27, Peter K. Kaiser M.D., will present for the first time the primary endpoint of the risuteganib US Phase 2 clinical trial for intermediate dry AMD at ASRS.

In June, Allegro announced topline results of the Phase 2 intermediate dry AMD clinical trial, which met its primary endpoint with 48 percent of patients in the risuteganib arm at week 28 gaining ≥ 8 letters from baseline, compared to 7 percent 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 (SAEs). In addition to complete best corrected visual acuity (BCVA) data, secondary outcomes for several patient cases will be presented at ASRS.

“Allegro for the very first time will present the results of our risuteganib Phase 2 intermediate dry AMD trial to the clinical community at ASRS and OIS,” said Dr. Karageozian. “To see such visual acuity gains in patients with dry AMD, a sight-threatening disease for which there is currently no available treatment, is very encouraging. We look forward to sharing this promising data along with Allegro’s progress in advancing our integrin-regulating platform in retina and into new ocular therapeutic areas.”

The corporate and scientific presentations are scheduled as follows:

Thursday, July 25: 9:34-9:40 AM
Ophthalmology Innovation Summit, The Ritz-Carlton, Chicago
Addressing the Unmet Need of Ocular Diseases with a Novel Integrin-Regulating Portfolio. Vicken Karageozian, M.D.

Saturday, July 27: 8:28-8:34 AM
American Society of Retina Specialists Annual Meeting 2019, Hyatt Regency Chicago
Safety and Efficacy of Risuteganib in Intermediate Nonexudative Age-Related Macular Degeneration: First Time Results From a Phase 2 Study. Peter K. Kaiser, M.D.

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, simultaneously acts on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as intermediate dry AMD and diabetic macular edema (DME). Risuteganib recently successfully completed a U.S. Phase 2 intermediate dry AMD study and also successfully completed two Phase 2 DME studies. Expanding its integrin-regulating portfolio, Allegro has developed ALG-1007, an integrin-regulating drug candidate for topical use in dry eye disease. 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.

###

Allegro Ophthalmics Announces Positive Topline Vision Results of Phase 2 Study Evaluating Risuteganib in Patients with Intermediate Dry Age-Related Macular Degeneration

— U.S. Phase 2 Trial Met Primary Endpoint with Statistical Significance
— 48% of Patients in the Risuteganib Arm Gained ≥ 8 Letters of Vision from Baseline

Download the PDF

SAN JUAN CAPISTRANO, CA — June 4, 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 topline results of its U.S. Phase 2 study of risuteganib (Luminate®) for the treatment of intermediate nonexudative age-related macular degeneration (dry AMD). The clinical trial met its primary endpoint with 48 percent of patients in the risuteganib arm gaining ≥ 8 letters of vision at week 28 compared to baseline.

The primary endpoint of the Phase 2 study was the proportion of subjects with a ≥ 8 letters of vision gain with two risuteganib injections versus one sham treatment. The 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. At baseline, 40 patients were randomized to receive either intravitreal 1.0mg risuteganib or sham injection. At week 16, patients in the risuteganib arm received a second dose of 1.0mg risuteganib, and patients in the sham arm crossed over and received a single dose of 1.0mg risuteganib. The primary endpoint was the percentage of the population with ≥ 8 letters ETDRS BCVA gain from baseline to week 28 in the 1.0mg risuteganib arm versus from baseline to week 12 in the sham arm. The primary endpoint was prespecified as ≥ 8 letters to account for the variability in visual acuity measurements among 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). Secondary outcomes, including microperimetry, color vision, and low luminance visual acuity, are currently being evaluated; results of which will be released in the upcoming weeks.

“Allegro’s anti-integrin portfolio continues to show great progress,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC. “This progress is supported by recent findings released last month establishing that our ALG-1007 drug candidate for dry eye disease performed well in an ex-U.S. proof-of-concept clinical trial and now by these positive topline U.S. Phase 2 results of risuteganib for intermediate dry AMD. It is very encouraging to see such robust visual acuity gains in patients with dry AMD, a sight-threatening disease for which there is currently no available treatment. It is also exciting to see that these initial clinical findings in dry AMD confirm our extensive preclinical findings and earlier clinical studies that suggested risuteganib could restore visual function.”

“I’ve always believed in the potential of integrin inhibition as an alternative target pathway for the treatment of retinal diseases. This Phase 2 data is very promising and suggests what we have always hoped to see: a potential therapy for intermediate dry, nonexudative AMD,” said Peter K. Kaiser, M.D., Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine and staff surgeon in the Vitreoretinal Department at the Cole Eye Institute, Cleveland Clinic. “If we could add a treatment to our armamentarium that can improve vision in this population of patients that currently is untreatable, this would be significant. I am hopeful for the future of this drug candidate based on the consistency of the data that I have seen across different endpoints.”

The full study results, including primary and secondary outcomes, will be presented by Dr. Kaiser at the American Society of Retina Specialists (ASRS) Annual Meeting 2019 in Chicago, IL on Saturday, July 27th.

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 studies and also has successfully completed 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 dry eye disease. 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.

###