Category: Press Releases

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SAN JUAN CAPISTRANO, Calif. — July 24, 2017 — Allegro Ophthalmics, LLC today announced the completion of a private round of equity financing for $10.7 million.  With this infusion of capital, the company is strongly positioned to reach future corporate milestones.  Allegro is a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases.  The company’s lead drug candidate, Luminate®, has successfully met the endpoints for two Phase 2 monotherapy studies for the treatment of diabetic macular edema (DME) and vitreomacular traction (VMT).  In addition, topline results of its Phase 2, Stage 2 DME clinical trial in which Luminate is being evaluated in combination and as an adjunctive therapy with anti-VEGFs will soon be announced.

“The additional capital positions us well to complete multiple Phase 2 clinical trials and prepare for Phase 3 studies.  This financing validates the potential for Luminate to be a valuable treatment option for patients with sight-threatening retinal diseases,” says Vicken Karageozian, MD, president and chief medical officer, Allegro Ophthalmics.

Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.  By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate has been shown in clinical studies to effectively maintain and improve vision by regressing and inhibiting new blood vessel formation, as well as reducing vascular leakage.  Currently in Phase 2 clinical trials for multiple indications, Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S.  Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is establishing integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases.  Allegro’s lead investigational drug, Luminate, has successfully met the endpoints for its first two Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and be a new treatment option for patients with diabetic macular edema and age-related macular degeneration.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit allegroeye.com.

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

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SAN JUAN CAPISTRANO — March 7, 2017 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases, today announced that Melvin Sarayba, MD, has joined the company as vice president of clinical affairs.  In his new role,
Dr. Sarayba is responsible for Allegro’s US and international clinical program for Luminate,^® which met its primary and secondary endpoints in the DEL MAR Phase 2b clinical trial for diabetic macular edema (DME), the company announced in October, 2016.

An ophthalmic surgeon with an extensive clinical research background and two decades of product development and commercialization experience, Dr. Sarayba has worked for multiple successful ophthalmic companies, including IntraLase, AMO, WaveTec, LenSx Lasers, Alcon Laboratories and ClarVista Medical.At LenSx, he served as vice president of clinical affairs leading the company’s efforts on ophthalmic medical device product development, product improvement, and new applications.
Dr. Sarayba also has designed and led clinical trials at various stages of the life cycle.  As the head of global medical affairs for the cataract franchise at Alcon, he was responsible for key clinical initiatives for the company’s entire cataract portfolio.  Dr. Sarayba completed his fellowship training at the University of California, Irvine.  He is a prolific innovator with 10 patents and has authored or co-authored numerous peer-reviewed publications.

“Melvin’s history of successfully running pivotal clinical trials for innovative startup companies like IntraLase and LenSx and for respected industry leaders like Alcon and AMO make him a valuable addition to the Allegro team,” says Hampar Karageozian, MSc, MBA, co-founder and chief executive officer, Allegro Ophthalmics.  “I am confident that Dr. Sarayba will be an enormous asset to Allegro and will continue to propel Luminate, which has thus far shown very promising efficacy and safety results in Phase 2 clinical trials across multiple indications, through trials and on to commercialization.”

About Luminate
Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.  By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision.  Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S. Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases.  Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision.  For more information, visit allegroeye.com.

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

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SAN JUAN CAPISTRANO — December 15, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases, today announced completion of enrollment in the second stage of its DEL MAR trial that is evaluating the safety and efficacy of Luminate® in combination and as an adjunctive therapy with anti-VEGFs in patients with diabetic macular edema (DME).  Topline results from the DEL MAR Stage 1 monotherapy trial, in which Luminate^® met its primary and secondary endpoints, demonstrating equivalence to bevacizumab monotherapy with half the number of injections, were released in October.

DEL MAR Stage 2 is a double masked, placebo-controlled, randomized, multi-center, 5-month Phase 2b trial designed to evaluate the safety and efficacy of intravitreal injections of Luminate^® 0.5 mg or 1.0 mg in combination with bevacizumab 1.25 mg and as an adjunctive therapy after treatment with a single treatment with bevacizumab 1.25 mg in patients with DME.  The trial enrolled 75 patients and is being conducted at approximately 14 sites across the U.S.  The company expects to report top-line data in the first half of 2017.

“With the recent readout of the topline results of DEL MAR Stage 1 and now the completion of the last patient enrollment in DEL MAR Stage 2, Allegro has achieved another clinical development milestone for this drug candidate,” says Vicken Karageozian, MD, President and Chief Medical Officer, Allegro Ophthalmics. “DEL MAR Stage 1 met its primary and secondary endpoints demonstrating strong efficacy and safety in monotherapy treatment with Luminate^®.  We are cautiously optimistic that DEL MAR Stage 2 data will show similar outcomes.”

“DEL MAR Stage 1 results appear to be very promising,” said Peter K. Kaiser, M.D., Chaney Family Endowed Chair in Ophthalmology Research and Professor of Ophthalmology, Cleveland Clinic Lerner College of Medicine, and member of Allegro’s Scientific Advisory Board.  “I am hopeful that Luminate^® in combination or as an adjunctive therapy with anti-VEGFs may prove to be as efficacious as monotherapy treatment with Luminate^®.  A new option with a completely novel mechanism of action that improves visual and anatomic outcomes would be a welcome addition to doctors and our patients.”

About Luminate^®
Luminate^®, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.  By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate^® has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision.  Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate^® is an investigational drug not approved by the FDA for commercial sale in the U.S.  Allegro maintains commercial rights to Luminate^® in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases.  Allegro’s lead investigational drug, Luminate^®, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit allegroeye.com.

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

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SAN JUAN CAPISTRANO, CA —NOVEMBER 21, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases, today announced that William J. Link, PhD, has been elected to Allegro’s board of directors.

Dr. Link is co-founder and a managing director of Versant Ventures, a global healthcare investment firm where he specializes in early stage investing in medical devices.  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.  In addition, Dr. Link founded and served as President of American Medical Optics (AMO), a division of American Hospital Supply Corporation, which was sold to Allergan in 1986.

“Bill is a pioneer in the healthcare industry and we are excited to welcome him to Allegro’s board of directors,” said Hampar Karageozian, MSc, MBA, co-founder and chief executive officer, Allegro Ophthalmics. “Bill’s vast experience and expertise in building and managing successful healthcare companies, particularly in the area of ophthalmology, will be a tremendous asset that will ensure Allegro’s continued success as we move our lead drug candidate Luminate® toward commercialization.”

“I have admired how Allegro’s dynamic leadership team has quickly and cost-effectively made significant progress in its Luminate® drug development program across multiple indications,” said Dr. Link. “With this recent progress, including last month’s news on the positive results from the DEL MAR Phase 2b DME trial, it is a very exciting time to join Allegro’s board of directors.”

About Luminate
Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.  By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision.  Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S.  Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases.  Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit allegroeye.com.

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

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DEL MAR Study Meets Primary and Secondary Endpoints Demonstrating
Equivalence to Anti-VEGF with Half the Number of Injections

SAN JUAN CAPISTRANO, CA — October 13, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases, today announced that the DEL MAR Phase 2b clinical trial evaluating Luminate® (ALG-1001) in 136 patients with diabetic macular edema (DME) met its primary and secondary endpoints, demonstrating promising visual acuity gains and reduction in central macular thickness (CMT) that were equivalent to bevacizumab monotherapy.

The primary endpoint of the DEL MAR Phase 2 study was non-inferiority to bevacizumab (defined as ≤3-letter difference) in mean change in best-corrected visual acuity (BCVA) at 20 weeks. The Luminate^® results were achieved after 3 injections and 12 weeks off treatment, compared to 6 injections given every 4 weeks with bevacizumab. The data showed the mean gain in BCVA was 5.2 letters for patients in the 1.0 mg Luminate^® arm 12 weeks off Luminate^® loading compared to 7.0 letters for patients in the 1.25 mg bevacizumab arm dosed every 4 weeks. The secondary endpoint was non-inferiority to bevacizumab (defined as ≤30 µm difference) in mean change in CMT as measured by optical coherence tomography (OCT). At week 20, patients in the 1.0 mg Luminate^® arm showed a mean reduction of 77µm 12 weeks off Luminate^® loading versus 104µm in the 1.25 mg bevacizumab arm dosed every 4 weeks.

The controlled, double-masked, multi-center, dose-ranging study, which included three Luminate^® arms (1.0 mg, 2.0 mg, and 3.0 mg) treated with 3 monthly Luminate^® loading injections followed by 12 weeks off treatment, and a 1.25 mg bevacizumab arm of 6 monthly injections, also found that Luminate^® was well-tolerated with no drug toxicity or intraocular inflammation noted. These safety results are consistent with previously conducted Luminate^® studies on human subjects where there were no reports of significant inflammation, no afferent pupillary defects, and no evidence of retinal tears or detachments.

“These positive results continue to affirm the safety and efficacy of Luminate^®, and confirm its 12-week monotherapy durability,” said Vicken Karageozian, M.D., President and Chief Medical Officer, Allegro Ophthalmics. “Allegro is deeply committed to developing novel therapies that address vitreoretinal patients’ unmet needs with new mechanisms of action that have the potential to help a larger population.”

“The DEL MAR Phase 2 results appear to be very promising,” said Peter K. Kaiser, M.D., Chaney Family Endowed Chair in Ophthalmology Research and Professor of Ophthalmology, Cleveland Clinic Lerner College of Medicine, and member of Allegro’s Scientific Advisory Board. “With half the number of injections and a unique mechanism of action, Luminate^® has demonstrated non-inferiority to anti-VEGF injections and appears to be extremely well-tolerated. Luminate^® may potentially provide physicians and DME patients with a completely new option that improves visual and anatomic outcomes while reducing the burden of intravitreal injections.”

About Luminate^®
Luminate^®, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.  By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate^® has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision.  Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate^® is an investigational drug not approved by the FDA for commercial sale in the U.S.  Allegro maintains commercial rights to Luminate^® in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases.  Allegro’s lead investigational drug, Luminate^®, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit allegroeye.com.

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

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SAN JUAN CAPISTRANO, CA — October 3, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced completion of enrollment in its PACIFIC Phase 2b clinical trial that is evaluating the safety and efficacy of Luminate^® (ALG-1001) in inducing posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (DR).

“We are very pleased to have completed patient enrollment in the PACIFIC trial,” said Vicken Karageozian, M.D., President and Chief Medical Officer, Allegro Ophthalmics. “There are currently no practical treatment options available for PVD induction in non-proliferative DR, resulting in a significant need for novel, non-surgical treatments that optimize long-term clinical outcomes. We are optimistic that Luminate^® will continue to show efficacy and provide meaningful therapeutic benefit to patients with diabetic retinopathy and other vitreoretinal diseases.”

PACIFIC is the third Phase 2 study of Luminate^® to complete enrollment. Top-line results from PACIFIC are anticipated to be available within the first half of 2017, and those from the DEL MAR Phase 2b trials evaluating Luminate^® in patients with diabetic macular edema (DME) are expected Q4 2016.

“PACIFIC is an important study that will broaden and confirm our understanding of this non-surgical option for patients with mild to moderate non-proliferative diabetic retinopathy who may potentially proceed to vision threatening disease over time,” said Baruch Kuppermann, M.D., Ph.D., Professor of Ophthalmology and Biomedical Engineering, Chief of the Retina Service, and Vice-Chair of Academic Affairs at the Gavin Herbert Eye Institute, University of California Irvine School of Medicine, investigator, and member of Allegro’s Scientific Advisory Board. “There is a significant body of evidence that suggests inducing a PVD may inhibit the progression of retinal disease.^1-4 An early Phase 1 trial has already demonstrated that Luminate^® can induce PVD in patients with DME.”

PACIFIC is a double-masked, placebo-controlled, randomized, multi-center, dose-ranging trial to evaluate intravitreal injections of Luminate^® in patients with non-proliferative DR. The trial enrolled 100 patients who were randomized to one of five treatment groups that included four Luminate^® groups (1.0 mg, 2.0 mg, 3.0 mg or 4.0 mg) and a balanced salt solution (BSS) placebo group. All study subjects return for examinations every four weeks for five months with the main endpoint being PVD induction based on optical coherence tomography and/or B-scan ultrasound.

About Luminate^®
Luminate^®, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels. By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate^® has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision. Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate^® is an investigational drug not approved by the FDA for commercial sale in the U.S. Allegro maintains commercial rights to Luminate^® in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases. Allegro’s lead investigational drug, Luminate^®, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction. By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit allegroeye.com.

References:

1. Ono R, Kakehashi A, Yamagami H, et al. Prospective assessment of proliferative diabetic retinopathy with observations of posterior vitreous detachment.  Int Ophthalmol. 2005;26(1-2):15-19.
2. Ghazi NG, Ciralsky JB, Shah SM, et al. Optical coherence tomography findings in persistent diabetic macular edema: the vitreomacular interface. Am J Ophthalmol 2007;144(5):747-54.
3. Ophir A, Trevino A, Fatum S. Extrafoveal vitreous traction associated with diabetic diffuse macular oedema. Eye (Lond) 2010;24(2):347-53.
4. Tolentino MS, Tolentino AJ, Tolentino MJ. Current and investigational drugs for the treatment of diabetic retinopathy. Expert Opin Investig Drugs 2016;25(9);1011-22.

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

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— Ron Kurtz, MD, and Mark Livingston Join Allegro Ophthalmics’ Board of Directors

SAN JUAN CAPISTRANO, CA —AUGUST 1, 2016 — Allegro Ophthalmics, LLC, a late stage biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced that Ron Kurtz, MD, president and CEO of Calhoun Vision, and Mark Livingston, president and CEO of PrimaPharma, have been elected to Allegro’s board of directors.

“Ron and Mark bring tremendous operational, financial and leadership expertise and experience to Allegro,” said Hampar Karageozian, MSc, MBA, Co-Founder and Chief Executive Officer, Allegro Ophthalmics. “As a successful entrepreneur and a retina specialist, Ron brings a unique set of business and clinical skills. Mark has an impressive record leading several successful companies, and is also a CPA with significant financial expertise.  I am confident they will make considerable contributions as we move our lead drug candidate Luminate® through clinical trials and will be instrumental in ensuring Allegro reaches its goals.”

“It is a very exciting time to be joining Allegro’s board of directors,” said Dr. Kurtz. “Luminate has shown excellent safety and positive efficacy data in clinical trials to date. I look forward to assisting with the analysis of the ongoing trials and working with the management team on the strategic development of Luminate.”

“I have worked closely with Allegro over the past six years and am honored to be joining their board,” said Mr. Livingston. “I have tremendous respect for Hampar and the other board members, and I look forward to working with them to move the company forward.”

Dr. Kurtz is the president and CEO of Calhoun Vision, developer of a proprietary intraocular lens (IOL) that can be enhanced post-operatively to reduce spectacle dependence.  He was previously co-founder, president and CEO of LenSx Lasers, which was acquired by Alcon in 2010, and of IntraLase Corporation, which was acquired by Advanced Medical Optics (AMO) in 2008. A retina specialist, Dr. Kurtz served on the faculty at the University of Michigan and the University of California, Irvine. Dr. Kurtz earned his BA in Biochemistry from Harvard College and his MD from the University of California, San Diego.

Mr. Livingston has been at the helm of several organizations over the last 25 years, including President and CEO of PrimaPharma, a CDMO that has been instrumental in providing solutions to Allegro’s clinical trial and manufacturing needs.  He is founding partner at accounting firm Campbell Boyd & Livingston and has served in a variety of executive leadership roles at several well-known corporations, including Motels of America, Road Runner Sports, and Sims Snowboards.  A founding shareholder of PrimaPharma’s predecessor entity, Sorrento Biochemical, Mr. Livingston has served on the product advisory board of Blanchard Training and Development and on the board of The Planning Forum, as well as being a past chairman of The Management Consulting Services committee for the San Diego chapter of the California Society of Certified Public Accountants.

About Luminate
Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.  By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision.  Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S.  Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases.  Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit allegroeye.com.

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

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— Vicken Karageozian, MD, Named President and Chief Medical Officer
— John Park, PhD, Named Chief Scientific Officer and Vice President of Manufacturing Development

SAN JUAN CAPISTRANO, CA — MARCH 15, 2016 — Allegro Ophthalmics, LLC, a late stage biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced two promotions within the company’s senior management team.  Vicken Karageozian, MD, formerly Chief Technical Officer (CTO), has been promoted to President and Chief Medical Officer, and John Park, PhD, formerly Vice President of Product Development, has been promoted to Chief Scientific Officer and Vice President of Manufacturing Development.

“Vicken and John have made significant contributions to Allegro that have resulted in the company’s growth and success to date,” says Hampar Karageozian, MSc, MBA, Co-Founder and Chief Executive Officer, Allegro Ophthalmics. “They have both demonstrated a strong commitment to bringing our drug development platform from concept to development and through multiple clinical trials, while successfully brokering key partnerships and raising capital. I’m proud to recognize their contributions with these promotions, and am confident that their leadership and vision will be instrumental in ensuring Allegro reaches our goals.”

“Allegro’s innovative approach to treating vitreoretinal diseases shows great promise,” says Dr. Karageozian. “The company has made significant progress to date, including moving its integrin peptide therapy from inception, through discovery, to demonstrating preclinical proof-of-concept, and establishing safety and efficacy in Phase 1/2 trials in multiple indications in less than six years.  I am honored to lead the talented Allegro team in this new capacity and look forward to working diligently to reach our goals so that doctors and patients will be able to soon realize the benefits of our lead drug candidate, Luminate®.”

As President and Chief Medical Officer, Dr. Karageozian will be responsible for the development and execution of Allegro’s corporate, clinical and financial strategies. Dr. Karageozian has more than 20 years’ experience building, leading, and fundraising companies in the ophthalmic pharmaceutical space. An ophthalmic surgeon by training, Dr. Karageozian is the co-founder of three ophthalmic biotech companies, including ISTA Pharmaceuticals, Inc., Vitreoretinal Technologies, Inc., and Allegro, and is the inventor or co-inventor of numerous ophthalmic pharmaceuticals with more than 20 patents issued on his drug discoveries. In addition, Dr. Karageozian has been instrumental in the raising of over $200M in venture and institutional capital.

Dr. Park will lead the scientific discovery, preclinical development and manufacturing development to support Allegro’s drug platform, including that of Luminate.  Dr. Park’s experience spans four decades of bringing ophthalmic drugs from concept to market, specifically in research and development as well as product development.  He served as principle research scientist at Allergan for 16 years and as Vice President of ISTA Pharmaceuticals, Vitreoretinal Technologies, and SK Biopharmaceuticals for 15 years where he was responsible for product development, manufacturing and quality control.  Dr. Park also is the inventor or co-inventor of numerous ophthalmic pharmaceuticals with more than 20 patents issued on his drug discoveries.

“It is an honor to be a part of the Allegro organization in its mission to bring new and innovative therapies to market that will help the millions of people who are at risk of vision loss and blindness retain their vision,” says Dr. Park.

About Luminate
Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.  By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision.  Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S.  Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases.  Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit allegroeye.com.

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

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SAN JUAN CAPISTRANO — January 5, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced completion of enrollment in its DEL MAR Phase 2b trial that is evaluating the safety and efficacy of Luminate® (ALG-1001) in patients with diabetic macular edema (DME).

DEL MAR is a double masked, placebo-controlled, randomized, multi-center, 6-month Phase 2b trial designed to evaluate the safety and efficacy of intravitreal injections of Luminate^® compared to the current standard of care for patients with DME.  The trial enrolled 120 patients who were randomized to one of four treatment groups that included three Luminate^® groups (1.0 mg, 2.0 mg, or 3.0 mg) and a bevacizumab group. The trial is being conducted in approximately 40 sites across the U.S.

“Completing the last patient enrollment in the DEL MAR trial on schedule represents another significant clinical development milestone for this drug candidate, and moves us a step closer to potentially bringing this new category of treatment forward to help DME patients,” says Vicken Karageozian, MD, Chief Technical Officer, Allegro Ophthalmics, LLC. “The protocol follows the prospective analysis of the Phase 1 DME study, which demonstrated strong safety and efficacy in monotherapy treatment with Luminate^®.  We are cautiously optimistic that Phase 2b data will show similar outcomes.”

“I’m pleased to be participating in this important study which has the potential to benefit the millions of diabetics who are at risk of losing their vision,” says David Boyer, MD, Clinical Professor of Ophthalmology at USC/Keck School of Medicine and member of Allegro’s Scientific Advisory Board. “There is a significant need to find better treatment options that reduce the number of intravitreal injections, while improving vision for our diabetic patients. In clinical studies to date, Luminate^® has been shown to be an enhanced clinical benefit for those patients who either don’t respond to anti-VEGF therapy or plateau with less than excellent vision.”

About Luminate^®
Luminate^®, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.  By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate^® has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision.  Currently in Phase 2b clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate^® is an investigational drug not approved by the FDA for commercial sale in the U.S.  Allegro maintains commercial rights to Luminate^® in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases.  Allegro’s lead investigational drug, Luminate^®, is currently in Phase 2b studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit allegroeye.com.

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

Third party trademarks used herein are trademarks of their respective owners.

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— Cooper, a Finance Veteran, Most Recently Served at WaveTec Vision Systems (Alcon)
— Genead, an Ophthalmologist and Retina Specialist, Brings Proven Record in Ophthalmic Drug Development

SAN JUAN CAPISTRANO, CA — OCTOBER 21, 2015 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced that Scott Cooper has joined the company as Chief Financial Officer (CFO) and Vice President of Business Development, and that Mohamed Genead, MD, has been named Executive Medical Director.

“We are delighted to welcome Scott and Mohamed to Allegro,” says Hampar Karageozian, MSc, MBA, Co-Founder and Chief Executive Officer, Allegro Ophthalmics. “Scott’s incredibly successful record at WaveTec and IntraLase demonstrates how exceptionally well-prepared he is to lead Allegro’s finance and business development functions.  Mohamed’s exceptional 15 years of clinical research and drug development experience in retina will serve Allegro well as we move our lead investigational drug Luminate® through multiple clinical trials for several vitreoretinal indications.  With these two new additions, Allegro is poised for much growth and success.”

A veteran finance executive, Mr. Cooper has spent nearly his entire career, which spans more than 25 years, in financial operations and accounting at numerous medical device and high-tech companies, and has worked for ophthalmic medical device companies for the last 11 years.  Most recently, Mr. Cooper served as the CFO of WaveTec Vision Systems, Inc., joining the company in 2007.  He helped guide the company through the development and commercialization stages of its intraoperative aberrometer (ORA) that ultimately led to the recent sale of WaveTec to Alcon, a division of Novartis.  Prior to WaveTec, Mr. Cooper was Corporate Controller at IntraLase Corp., helping to take it from a private company through IPO to the ultimate sale of the company to Advanced Medical Optics.

“This is a very exciting time for Allegro,” says Mr. Cooper.  “Should Luminate continue to show the same results in its clinical program as it has in earlier stages, Allegro is uniquely positioned to make a significant contribution to the prevention of vision loss from retinal disease. I am excited to join the Allegro team and look forward to supporting the company’s strategic vision and growth objectives.”

In his role at Allegro, Dr. Genead will work to drive the Luminate platforms into further clinical development as he works closely with the R&D, manufacturing, and product development teams, and will be responsible for running the U.S. and international clinical studies of Luminate in diabetic macular edema (DME) and posterior vitreous detachment.  Prior to joining Allegro, Dr. Genead was Global Medical Director of Clinical Development in the Ophthalmology/Retina therapeutics area at Allergan, where he was responsible for such tier-1 projects as DARPins for neovascular age-related macular degeneration (AMD) and DME, and Brimonidine DDS implants for geographic atrophy.  In addition, he served as subject matter and translational medicine expert on retina therapeutics and discovery.  Before joining Allergan, Dr. Genead was Clinical Professor of Ophthalmology, Department of Ophthalmology and Visual Sciences, at the University of Illinois in Chicago.  Dr. Genead sits on the board of several organizations and scientific advisory boards, and is the author of more than 40 peer-reviewed papers.

“I’m looking forward to working with the Allegro team to advance Luminate’s clinical program across multiple indications and phases.  There is a great need for novel, alternative therapies to treat a host of vitreoretinal diseases,” says Dr. Genead.  “Based on the clinical results to date, Luminate has the potential to be a valuable treatment option to millions of people who are at risk of vision loss and blindness.”

About Luminate
Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.  By utilizing two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision.  Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S.  Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases.  Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, wet age-related macular degeneration, and vitreomacular traction.  By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit stg.allegroeye.com.

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

 

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