Retina News

 

Positive 2-Year Results Announced in LHON Gene Therapy Trial

In the phase 3 REVERSE clinical trial, patients with Leber hereditary optic neuropathy (LHON) treated with GS010 (GenSight Biologics) showed continued efficacy at nearly 2 years after initial treatment, according to the company. The 96-week top-line data were announced in a press release.

Mean improvement in BCVA from baseline was +15.4 ETDRS letters in GS010-treated eyes, according to GenSight. Patients were treated with a single injection of the gene therapy in one eye within 6 to 12 months of disease onset.

Of note, bilateral improvement in both BCVA and contrast sensitivity has been noted.

“The data show that both the treated and the sham eye improved in both high and low contrast, defying the accepted natural history of this disease and improving upon it,” said Robert C. Sergott, MD, chief of the Wills Eye Hospital neuro-ophthalmology service and director of the new Annesley EyeBrain Center at Thomas Jefferson University, both in Philadelphia. “The behavior of the untreated eye must also make us re-examine what we thought we knew as possibly dogma and be open to the idea that gene therapy delivered into one eye may be able to access the contralateral eye.”

Results of a second phase 3 trial, RESCUE, which includes patients who have had LHON for 6 months or less, will be available by the end of the third quarter of this year, according to the company. A third phase 3 study for the same condition, REFLECT, is ongoing. Patients in that trial will be treated in both eyes.


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Congressional Bill Aims to Streamline and Improve Transparency in Prior Authorization

Sponsored by a bipartisan group of House lawmakers, HR 3107, the Improving Seniors’ Timely Access to Care Act of 2019, authorizes CMS to oversee Medicare Advantage plans’ use of prior authorization.

AbbVie to Buy Allergan for $63 Billion

The makers of Humira and Botox merge as AbbVie enters eye care. The deal is expected to close early next year.

FDA Accepts Orphan NDA for Brilliant Blue G Ophthalmic Solution

The proposed indication for Brilliant Blue G ophthalmic solution is to selectively stain the internal limiting membrane.

Phase 3 SOLACE Trial Fails to Meet Primary Endpoint in Noninfectious Anterior Uveitis

Aldeyra Therapeutics announced results, which showed that statistical significance was not achieved for the primary or secondary endpoints.

Alcon Debuts as Independent, Publicly Traded Company

Alcon completed its separation from Novartis in April, and its shares began trading on the SIX Swiss Exchange and New York Stock Exchange under the symbol ALC.

 

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About Retina Today

Retina Today is a publication that delivers the latest research and clinical developments from areas such as medical retina, retinal surgery, vitreous, diabetes, retinal imaging, posterior segment oncology and ocular trauma. Each issue provides insight from well-respected specialists on cutting-edge therapies and surgical techniques that are currently in use and on the horizon.