Father and son Hampar and Vicken Karageozian plan to take their company to the exit sans venture capital. San Juan Capistrano-based Allegro Ophthalmics LLC, which develops drugs for vitreoretinal diseases—those that affect the back part of the eye, such as diabetic retinopathy and macular degeneration—is the third company that Hampar and Vicken Karageozian have co-founded. Previous endeavors include eye drugmakers Vitreoretinal Technologies Inc. in Irvine and ISTA Pharmaceuticals Inc., founded in 1999 and 2000, respectively.
Vitreoretinal Technologies, which developed several eye drugs, closed in 2009 after the phase three trial of its drug candidate, Vitreosolve, which was designed to treat diabetic retinopathy, was abandoned. The company reported that “this study has been terminated,” according to ClinicalTrials.gov.
ISTA, which develops drugs for several diseases and conditions, received Food and Drug Administration approval for drug Bromday, which treats inflammation after cataract surgery. It was acquired in 2012 by eye care company Bausch & Lomb for $500 million.
“Previously, we had very much experience with [venture capital] funding,” said Hampar, Allegro co-founder and chief executive. “We raised $160 million. We experienced a lot of dilution by the time [we sold ISTA]. We [Allegro] are not a VC-controlled company.”
He co-founded Allegro with his son, Vicken, president and chief medical officer, his daughter, Lisa Karageozian, director of clinical research, and John Park, chief scientific officer and vice president of manufacturing development. Together, the founders have a majority stake in the company.
Hampar co-founded ISTA and Vitreoretinal Technologies with Vicken and Park.
Park, who has over 30 years in ophthalmic research, served in similar roles at Vitreoretinal Technologies, ISTA, SK Pharmaceuticals and Allergan Pharmaceuticals. Hampar and Park met when they were at Allergan.
Allergan was acquired by Actavis PLC.
At this point, Allegro is funded completely through strategic partnerships. The company has raised more than $40 million from Senju Pharmaceutical Co. Ltd. in Japan, Hanmi Pharmaceutical in Korea, The Helmsley Charitable Trust in New York and individual series A investors, according to a company spokesperson.
Allegro’s lead drug candidate, Luminate, an integrin peptide therapy, is made to treat vitreoretinal diseases by regressing and inhibiting new blood vessel formation. It’s developed in collaboration with the California Institute of Technology. Hampar and Park helped developed Luminate.
The growth of new blood vessels in areas that they’re not supposed to be can lead to blood and fluid leakage, eventually resulting in blindness.
Integrins are protein receptors that do more than just attach a cell to its surroundings or other cells. They also activate intracellular signals, transmitting information both outside-in and inside-out—triggering the cell to respond.
The introduction of Luminate interferes with blood vessel formation by inhibiting specific cells’ adhesion to integrin.
Vicken said anti-vascular endothelial growth factor (anti-VEGF), the current standard of care for treating conditions that include diabetic macular edema and diabetic retinopathy, doesn’t work for every patient.
VEGF is a protein that has been shown to stimulate abnormal blood vessel growth in the retina and macula. The current drug treatment using anti-VEGF inhibitors aims to reduce the level of VEGF, whereas Luminate binds to the back of the retina and shuts down production of the growth factors that cause abnormal blood vessels to form.
“The problem is [anti-VEGF worked on] only 50% of the patients, and there’s another half that is not responding to the treatment,” he said. “It’s not that anti-VEGFs aren’t good, but you can’t treat everything with one drug. We want to offer an alternative.”
Allegro is in various stages of clinical trials for a number of eye diseases, including wet age-related macular degeneration; vitreomacular adhesion and traction; diabetic macular edema; and diabetic retinopathy. Its most immediate targets are blurred vision caused by diabetes: diabetic macular edema and diabetic retinopathy.
Vicken noted that most available drugs require monthly injections, whereas Allegro’s has thus far shown that it can last up to four months before another injection is needed.
The company completed enrollment for a 100-patient second-phase clinical trial for diabetic retinopathy and another 75-patient second-phase clinical trial for diabetic macular edema. It is analyzing data for the former indication.
For the latter indication, Allegro said Luminate demonstrated safety and efficacy in an initial second-phase trial as a stand-alone treating diabetic macular edema. The company will now investigate the drug’s efficacy when injected with anti-VEGFs in a five-month multicenter trial.
Vicken said the company plans to move into phase three early next year, and he’s not ruling out acquisition or an initial public offering.
Allegro’s nine-member board of directors includes veteran healthcare investor Bill Link, co-founder and a managing director of Menlo Park-based healthcare investment firm Versant Ventures, which maintains a Newport Beach presence. The Karageozians and Park serve on the board.
Barry Kuppermann, professor of ophthalmology and biomedical engineering at the University of California-Irvine and chief of retinal service at UCI’s Gavin Herbert Eye Institute, sits on the company’s scientific board.
