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1 month ago | 
healio.com | Christine Klimanskis
Key takeaways: The FDA granted breakthrough therapy designation to veligrotug. Veligrotug demonstrated rapid reduction and resolution of diplopia in two phase 3 trials. Editor’s note: This is a developing news story. Please check back soon for updates. Viridian Therapeutics received breakthrough therapy designation from the FDA for veligrotug for the treatment of thyroid eye disease, according to a press release.
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1 month ago | 
healio.com | Christine Klimanskis
Key takeaways: Regenerative medicine advanced therapy designation expedites the development and review of therapies. The designation was supported by early clinical data from a phase 1/2 trial. Editor’s note: This is a developing news story. Please check back soon for updates. The FDA granted regenerative medicine advanced therapy designation to OPGx-LCA5 for the treatment of Leber congenital amaurosis due to genetic variations in the LCA5 gene, according to a press release from Opus Genetics.
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1 month ago | 
healio.com | Christine Klimanskis
April 17, 2025 1 min read FDA clears Leos laser system for glaucoma Add topic to email alerts Please provide your email address to receive an email when new articles are posted on Ophthalmic Business. Subscribe You've successfully added Ophthalmic Business to your alerts. You will receive an email when new content is published. Click Here to Manage Email AlertsBack to Healio We were unable to process your request. Please try again later.
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1 month ago | 
healio.com | M. Francesca Cordeiro |Michela Cimberle |Christine Klimanskis
SEVILLE, Spain — In this Healio Video Perspective, M. Francesca Cordeiro, MD, PhD, highlights three hot topics in glaucoma discussed at the Congress on Controversies in Ophthalmology. During COPHy’s glaucoma sessions, which Cordeiro co-chaired, several questions were addressed: Is phaco plus minimally invasive glaucoma surgery better than phaco alone? Is AI better than clinicians at making decisions? Is it possible to prevent glaucoma?
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1 month ago | 
healio.com | Christine Klimanskis |William Trattler
Key takeaways: The designation is for the treatment of chronic night driving impairment after keratorefractive surgery. Enrollment is complete in the VEGA-3 phase 3 clinical trial of phentolamine for presbyopia. The FDA granted fast track designation to phentolamine ophthalmic solution 0.75% to treat significant chronic night driving impairment in patients who have undergone keratorefractive surgery.
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1 month ago | 
healio.com | Varsha Pramil |Lianna Valdes |Christine Klimanskis
A 43-year-old woman presented with 6 months of recurrent bilateral eye pain and redness alongside spontaneous urticaria. She noted episodes of quarter-sized itchy lesions appearing on her abdomen, legs and arms one to two times a month that spontaneously resolved within 24 hours. Bilateral eye pain, redness and itching occurred after onset of rash and subsided with resolution of rash.
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1 month ago | 
healio.com | Justin Cooper |Christine Klimanskis
Key takeaways:Deseyne lenses are embedded with bioactive substances that are gradually released to improve hydration. The lenses will be available for myopia, hyperopia and astigmatism. The FDA approved the Deseyne daily disposable contact lens, which steadily releases bioactive substances that improve hydration and aid comfort, according to a press release from Bruno Vision Care. Paul M.
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1 month ago | 
healio.com | Christine Klimanskis
Key takeaways: The designation is intended to expedite the drug development and review process. This is the fourth designation from the FDA for ATSN-201. Editor’s note: This is a developing news story. Please check back soon for updates. The FDA granted regenerative medicine advanced therapy designation to ATSN-201, a gene therapy candidate for the treatment of X-linked retinoschisis, according to a press release from Atsena Therapeutics.
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1 month ago | 
healio.com | Alex Young |Christine Klimanskis |Emily Schehlein |Aakriti Garg Shukla
To tackle problems like sustainability and climate change, a lot of heads need to come together. EyeSustain has been holding monthly meetings since its inception in 2022. Emily M. Schehlein, MD, said attendance is always significant. “It’s important to make sure that everyone is an active part of the organization,” she said. “People are very dedicated, and everyone participates.
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1 month ago | 
healio.com | Michela Cimberle |Christine Klimanskis |Nancy M. Holekamp |Rodrigo Gonzalez |Rodrigo González
Key takeaways: One presenter said at-home OCT has the potential to improve outcomes in neovascular AMD through personalized care. Another said there are still barriers to overcome with monitoring programs. SEVILLE, Spain — Home monitoring of neovascular age-related macular degeneration, an interesting concept with many potential benefits, has entered the retina space in the U.S. with the Scanly Home OCT monitoring program from Notal Vision.
