IRIS Registry: Intelligent Research in Sight Registry
The IRIS™ Registry (Intelligent Research in Sight) is the nation's first comprehensive eye disease clinical registry. The American Academy of Ophthalmology is developing it as part of the profession's shared goal of continual improvement in the delivery of eye care.The IRIS Registry will be a centralized system for ophthalmology practices to promote practice innovations and achieve clinical excellence.
A Prospective Observational Study Comparing the Effectiveness of Treatment Strategies for Open-Angle Glaucoma
The primary objectives of the study are: To compare the proportion of patients who achieve a successful response to treatment (reduction in Intraocular Pressure (IOP) of >15%) between patients treated with laser surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty) with patients receiving additional medications, at 1-year post-treatment initiation. To compare the proportion of patients who achieve a successful response to treatment (reduction in IOP of >15%) between patients treated with other procedures (including incisional surgery, drainage device procedures, and other glaucoma procedures) with patients receiving additional medications, at 1-year-post-treatment initiation. The study is a prospective, observational cohort study and will not provide or recommend any treatment. Patients who have failed initial medical therapy with two glaucoma medications will be identified and enrolled at the time of scheduling of a laser surgery procedure or other procedure such as incisional surgery or drainage device, or initiation of an additional course of therapy with medication as determined by their physician. This inception cohort of new initiators of laser surgical treatment, other procedures, or additional medical therapy will be followed for 12 months. All decisions regarding treatment are solely at the discretion of the physician in accordance with their usual practice. Enrollment is expected to begin in February 2011 and continue through 12 months of follow-up after enrollment targets have been reached.
WHITE PLAINS, N.Y., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Iantrek, Inc. announced today that two of its scientific abstract presentations were accepted by the American Academy of Ophthalmology at the upcoming AAO meeting in San Francisco, CA, November 3-6, 2023. These presentations will highlight the clinical results of its CycloPen supraciliary interventional system for suprachoroidal outflow bio-tissue reinforcement as well as a combined dual-outflow trabecular and supraciliary intervention in Open Angle Glaucoma. Iantrek continues to validate its innovative MIGS technologies for supraciliary and trabecular outflow enhancement. At AAO 2023, its authorship team comprising of Doctors Sean Ianchulev, Ike Ahmed, Robert Weinreb, Arsham Sheybani, Gautam Kamthan, Farrel C Tyson, Ernesto Calvo, and Lautaro Vera will share 12-month safety and effectiveness data of Iantrek’s CycloPen System for supraciliary intervention with homologous bio-tissue reinforcement. The 12-month results in combination with cataract surgery demonstrated a 42% reduction in IOP from a medicated baseline of 22.6 mmHg to 13.2 mmHg. The mean number of glaucoma medications used was reduced from 1.3 to 0.5. The allograft scaffolding material was well-tolerated with durable and sustained effect. Iantrek’s second presentation reports on a novel combination MIGS intervention to address both the suprachoroidal and the trabecular outflow. The case series demonstrates surgical feasibility and MIGS-type safety of the dual outflow micro-interventional approach with potentially synergistic effect of the two procedures. Iantrek is a micro-interventional glaucoma company founded by ophthalmic innovator Sean Ianchulev, MD MPH, Professor of Ophthalmology at New York Eye and Ear of Mount Sinai. Iantrek is developing several next-generation MIGS technologies for dual-outflow enhancement utilizing advanced supraciliary, trabecular and bio-tissue µ-interventions.
Encinitas, California--(News - October 3, 2023) - Kiora Pharmaceuticals (NASDAQ: KPRX) has received Investigational New Drug Application approval in Australia to enroll up to six additional patients in the ABACUS study of KIO-301. ABACUS was initially designed to evaluate patients with Retinitis Pigmentosa (RP). Based on encouraging findings previously shared, Kiora sought this approval to evaluate additional patients with late-stage RP as well as those with late-stage Choroideremia (CHM), a rare form of hereditary retinal degeneration. Plans remain for Kiora to report topline results on the first six RP patients in the ABACUS study on November 4th at the American Academy of Ophthalmology retina subspecialty day.
Kiora previously reported preliminary data in late-stage RP patients finding KIO-301 safe and tolerable with promising signs of efficacy. KIO-301 is a small molecule photoswitch, a first-in-class therapeutic with the potential to restore vision across several inherited retinal diseases (IRDs), regardless of underlying gene mutations.
"Data collected from additional patients will provide further insight to guide continued stages of clinical development," explained Eric Daniels, M.D., Chief Development Officer at Kiora. "We are now in a position to expand this 'gene mutation-agnostic approach' to generate further proof-of-concept in patients with late-stage CHM. The common denominator in both RP and CHM is rod and cone degeneration, and that is precisely why KIO-301 has a good opportunity to make an impact."
Choroideremia is a rare X-linked, recessive, inherited retinal disorder affecting approximately 1 in 50,000 individuals. It is caused by a loss-of-function mutation in the CHM gene. Initial symptoms include loss of night vision and often leads to severe vision impairment and blindness. Kiora is working with the Choroideremia Research Foundation (CRF), the world's largest not-for-profit organization dedicated finding a cure for CHM, to assist in a deeper understanding of the disease as well as access to CRFs patient database and thought leaders to assist in trial enrollment and future study designs.
"Adding CHM into ABACUS is consistent with our sharpened focus in addressing orphan retinal diseases," added Dr. Daniels. "Running programs in multiple IRDs will allow for operational efficiencies while developing therapeutics for a major unmet need, like CHM. Our work with CRF brings the top thought leaders in the space and access to patient databases to ensure we are giving the best chance of success to the development of KIO-301 in CHM."
About Kiora Pharmaceuticals
Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of orphan retinal diseases. KIO-301 is being developed for the treatment of Retinitis Pigmentosa, and Kiora also plans to develop KIO-301 for Choroideremia and Stargardt's Disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. Kiora plans to develop KIO-104 for the treatment of posterior non-infectious uveitis. It is a next-generation, non-steroidal, immuno-modulatory and small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) with what Kiora believes is best-in-class picomolar potency and a validated immune modulating mechanism (blocks T cell proliferation and proinflammatory cytokine release).
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Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-301 and KIO-104, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, and Kiora's ability to reach a quorum at the adjourned Special Meeting. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, the ability to obtain any required regulatory approvals, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 23, 2023, or described in Kiora's other public filings. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law.
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100 项与 American Academy of Ophthalmology, Inc. 相关的药物交易