Christine Klimanskis

Copy Chief at Healio

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Harrow acquires US commercial rights to Byqlovi

2 weeks ago | healio.com | Christine Klimanskis

Read more Key takeaways: Byqlovi is approved for postoperative inflammation and pain after ocular surgery. The high-potency ophthalmic corticosteroid will be available later this year. Editor’s note: This is a developing news story. Please check back soon for updates. Harrow acquired the U.S. commercial rights for Byqlovi through a licensing agreement with Formosa Pharmaceuticals, according to a press release.
VG801 gene therapy in Stargardt disease receives rare pediatric disease designation

2 weeks ago | healio.com | Christine Klimanskis

Key takeaways: Dosing of the investigational therapy is underway in a phase 1/2 clinical trial. VeonGen is developing a functional endpoint as part of the FDA’s Rare Disease Endpoint Advancement Pilot Program. Editor’s note: This is a developing news story. Please check back soon for updates. The FDA granted VG801 rare pediatric disease designation in Stargardt disease, according to a press release from VeonGen Therapeutics.
Veligrotug receives breakthrough therapy designation for thyroid eye disease

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.
FDA grants RMAT designation to gene therapy for Leber congenital amaurosis

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.
FDA clears Leos laser system for glaucoma

2 months 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.
VIDEO: MIGS, AI and prevention addressed during glaucoma sessions at COPHy

2 months 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?
FDA grants fast track designation to phentolamine ophthalmic solution 0.75%

2 months 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.
Middle-aged woman presents with recurrent eye pain, skin rash

2 months 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.
FDA approves Deseyne hydrating contact lens

2 months 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.
FDA grants regenerative medicine advanced therapy designation to XLRS gene therapy

2 months 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.