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FDA accepts IND for Eyenovia's microdosed presbyopia formulation

The FDA has accepted an investigational new drug application for Eyenovias MicroLine intended for symptomatic treatment of near vision due to presbyopia, according to a press release. MicroLine is a proprietary pilocarpine formulation delivered via Eyenovias Optejet dispenser. The acceptance clears the way for Eyenovia to initiate the phase 3 VISION program, beginning with VISION-1, a double-masked, placebo-controlled, crossover, superiority trial, whose primary endpoint is binocular distance-co...

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New app promotes safe interaction between patient, practitioner

A new digital platform, Opti-Xpres, allows for contact-free interaction between patients and doctors to help prevent the spread of COVID-19. The HIPAA-compliant app can be used for patient onboarding, outreach and EHR synchronization. It can be customized for each patient to manage eye care appointments and paperwork and try on frames virtually. Healio Primary Care Optometry News talked with Larry Holle, OD, Opti-Xpres co-founder, about the technology. Healio: How can Opti-Xpres be implemented i...

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TearClear completes pre-IND meeting with FDA

TearClear and the FDA have completed a pre-investigational new drug meeting regarding development of and clinical study design for the companys preservative-free multidose latanoprost formulation for glaucoma. The treatment incorporates TearClears technology, which offers the only means of delivering a preservative-free dose directly from preserved solutions, the release said. The IND filing and commencement of the pivotal registration trial are intended for 2021, according to the release. The s...

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Advanced techniques can close difficult' macular holes

An inverted internal limiting membrane flap technique and autologous retinal transplantation can be used to successfully close certain full-thickness macular holes, according to a speaker at the virtual OSN New York Retina meeting. I want to emphasize that the success rate with a traditional PPV and ILM peeling for most macular holes exceeds 90%, Christina Y. Weng, MD, MBA, told Healio/OSN. However, certain types of holes, such as large, chronic or myopic, are intrinsically more difficult to fix...

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Janssen acquires rights for geographic atrophy gene therapy

Janssen Pharmaceuticals has acquired the rights to HMR59, an investigational one-time intravitreal injection gene therapy being developed for the treatment of geographic atrophy, from Hemera Biosciences, according to a press release. The therapy is intended to increase the ability of retina cells to make a soluble form of CD59, a protein that protects the retina from damage, thereby preventing damage and saving sight, the release said. A phase 1 study of the therapy in geographic atrophy is comp...

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The new normal: Making the most of telehealth

A panel of experts at the Primary Care Collaborative Annual Conference discussed ways to maximize the use of telehealth. Earlier this year, CMS said it would relax some of its telehealth rules during the COVID-19 public health emergency, leading to between a 1,000 to 10,000% increase in the utilization of telemedicine visits by some health systems, Ian Tong, MD, an adjunct clinical professor of medicine at Stanford University and chief medical officer of Doctor on Demand, said. A recent Universi...

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Careful handling of Tenon's capsule and conjunctiva key for Port Delivery System implant

The Port Delivery System with ranibizumab is an innovative investigational drug delivery system from Genentech that requires meticulous handling of Tenons capsule and conjunctiva during the implantation procedure to ensure success. The most important thing for retinal surgeons approaching this surgery is the frame of mind going into the surgery. It needs to be closer to the glaucoma specialist, and going back to our training with glaucoma procedures, in terms of the meticulous and careful handli...

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