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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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

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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.

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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

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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.

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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

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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.

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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

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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.

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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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