OcuTerra Raises $35 Million Series B Financing

OTT166 DR-EAM Phase 2 Study Expected to Commence Early 2022

Paul Karpecki, OD, FAAO, Appointed to Scientific Advisory Board

OcuTerra Therapeutics, Inc. (“OcuTerra”), a clinical stage ophthalmology company developing innovative drugs to treat ophthalmic diseases for which the current standard of care of “watch and wait” does not prevent or control the progression of disease, today announced the final close of a $35 million Series B financing. Proceeds will support the DR-EAM (Diabetic Retinopathy - Early Active Management) Phase 2 study of OTT166 in patients with moderate to severe non-proliferative and mild proliferative diabetic retinopathy. The study is expected to commence early next year.

Phase 1b clinical trials of OTT166 eye drops in patients with diabetic retinopathy and wet AMD have demonstrated safety, tolerability and clear clinical evidence of biological activity. OTT166 is a novel small molecule selective integrin inhibitor that OcuTerra has purpose engineered to have the required physiochemical characteristics to be able to reach the retina from eye drop application. Designed to be administered by the patient at home, OTT166 has the potential to dramatically change the treatment paradigm by enabling earlier, non-invasive treatment to preserve vision and prevent progression, thereby delaying or completely eliminating the need for intravitreal injections.

“OcuTerra is well-positioned to transform the treatment landscape for diabetic retinopathy, the leading cause of vision loss and blindness in working age adults in America,” said Kerrie Brady, Chief Executive Officer of OcuTerra. “The current standard of care for these patients is ‘watch and wait’ until vision deteriorates due to diabetic macular edema or the disease progresses to the proliferative form, at which point medically intensive and invasive eye injections and/or laser treatments are instituted. Our mission is to transform the standard of care with OTT166 to offer a non-invasive, easy to administer, effective treatment that can be prescribed earlier in the disease course by a broader range of eye care providers to avoid sight threatening complications, stop disease progression and potentially avoid invasive treatments. We look forward to evaluating OTT166 in Phase 2 trials beginning early next year.”

“OTT166 offers potential significant benefit for patients, caregivers and eye care practitioners by providing a non-invasive treatment option for people suffering from diabetic retinopathy,” said Carl Regillo, M.D., FACS, Chief of the Retina Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. “In addition to fulfilling the unmet need of offering a non-invasive treatment option, which would be acceptable to more patients, OTT166 can potentially be administered earlier than eye injections, which may prevent severe disease progression and functional vision loss. I am compelled by the early data and believe that OTT166 has the potential to transform the standard of care for patients with this disease.”

OcuTerra Expands Scientific Advisory Board

OcuTerra also announced the appointment of Paul M. Karpecki, OD, FAAO to its Scientific Advisory Board.

“We are delighted to have Dr. Karpecki join our Scientific Advisory Board as we move forward with the development of OTT166,” said David Tanzer, M.D., ophthalmologist and Chief Medical Officer of OcuTerra. “Paul is a leader and pioneer in the eye care field, and his commitment to innovation aligns with our mission to change the standard of care for the treatment of diabetic eye disease.”

“I am thrilled to join the Scientific Advisory Board of OcuTerra and represent the voice of Doctors of Optometry who manage over 70% of all patients with diabetic retinopathy in the U.S.,” said Dr. Karpecki. “Working closely with my fellow advisors from the retina and anterior segment ophthalmology communities, I am very excited about the development of OTT166, a topical drug candidate to prevent diabetic retinopathy disease progression and loss of visual function.”

Dr. Karpecki received his Doctor of Optometry degree from Indiana University and completed a Durrie Fellowship in Medical Cornea/Refractive Surgery in Kansas City in affiliation with the Pennsylvania College of Optometry. In 2017-2018 he completed a full year preceptorship in advanced retinal disease at Retina Associates of Kentucky, one of the top 20 retina practices in the country. He currently serves as Director of Cornea and External Disease for the Kentucky Eye Institute in Lexington KY. Dr. Karpecki is the Chief Clinical Editor for Review of Optometry, the most read journal in the profession, and chairman of the New Technology and Treatment Conferences. He is Medical Director for KEPLR Vision and Director of Cornea and External Disease for the Center for Sight in Carmel, IN. He was appointed to the Delphi International Society at Wilmer Johns Hopkins which included the top 25 dry eye experts in the world and co-chair for the previous two Tear Film and Ocular Surface Society Symposia. Dr. Karpecki served on the DEWS II Diagnostic Methodology Committee. He is also an Associate Professor at the Kentucky College of Optometry in Pikeville, KY and serves on the board of the charitable organization Optometry Giving Sight.

About OTT166

OTT166 is a novel, patented, potent and selective small molecule integrin inhibitor purpose engineered to have an optimum balance of physiochemical properties to allow it to distribute to the retina in high concentrations after topical (eye drop) administration to the eye. It selectively inhibits key integrin subtypes αvβ3, αvβ6 and αvβ8 to regulate cellular responses to VEGF and other growth factors known to contribute to development and progression of diabetic retinopathy and other ocular diseases. In early clinical studies in patients with diabetic retinal disease, OTT166 eye drops have demonstrated evidence of safety, tolerability, and biological activity.

About OcuTerra Therapeutics

OcuTerra Therapeutics, Inc. is developing innovative drugs for ophthalmic diseases for which the current standard of care does not prevent or control the progression of disease. Our initial therapeutic, OTT166, administered as an eye drop containing a novel integrin-inhibitor, is in clinical development to enable earlier intervention of diabetic retinopathy, a chronic, progressive disease that is one of the leading causes of vision loss globally. Our goal is to bring transformative treatments to clinicians and their patients who are consigned to watch and wait as disease progresses, ultimately requiring medically intensive and invasive therapy. www.ocuterratx.com

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