Latest News - Spark Therapeutics

Friday, November 10, 2017 | Clinical Trials, Retina, Spark Therapeutics

Three-year Follow-up Phase 3 Data Provide Additional Information on Luxturna in Patients with Biallelic RPE65-Mediated Inherited Retinal Disease

Spark Therapeutics announced new 3-year follow-up data from the continuing phase 3 trial of Luxturna (voretigene neparvovec), an investigational, potential one-time gene therapy for the treatment of p…

Read the full story

Thursday, October 12, 2017 | Clinical Trials, Spark Therapeutics

FDA Advisory Committee Unanimously Recommends Approval of Luxturna for Patients with Biallelic RPE65-Mediated Inherited Retinal Disease

Spark Therapeutics announced that the FDA's Cellular, Tissue and Gene Therapies Advisory Committee has unanimously recommended (16-0) approval of Luxturna (voretigene neparvovec), an investigation…

Read the full story

Wednesday, October 11, 2017 | Clinical Trials, Medical Studies, Spark Therapeutics

Spark Gene Therapy Improves Vision, At Least in Short Term: FDA

Spark Therapeutics’s experimental gene therapy for a rare inherited form of blindness improves vision, though it is unclear whether the benefit lasts over time, according to a preliminary review…

Read the full story

Wednesday, September 06, 2017 | Clinical Trials, Spark Therapeutics

Spark Therapeutics Announces Publication of Study Confirming Test’s Validity, Reliability, and Ability to Detect Change in Functional Vision

Spark Therapeutics announced that Clinical and Experimental Ophthalmology has published a prospective, observational study that provides robust evidence for the construct and content validity of …

Read the full story

Monday, July 31, 2017 | Clinical Trials, Retina, Spark Therapeutics

Spark Therapeutics Submits Marketing Authorization Application to European Medicines Agency for Investigational Luxturna (Voretigene Neparvovec)

Spark Therapeutics announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for Luxturna, the proposed trade name for voretigene nep…

Read the full story

Thursday, July 20, 2017 | Retina, Spark Therapeutics

Spark Therapeutics Receives Rare Pediatric Disease Designation for Investigational Luxturna (Voretigene Neparvovec) from FDA

Spark Therapeutics announced that the Offices of Orphan Products Development and Pediatric Therapeutics of the FDA have designated investigational Luxturna (voretigene neparvovec) as a drug …

Read the full story

Monday, July 17, 2017 | Clinical Trials, Spark Therapeutics

Spark Therapeutics’ Biologics License Application for Investigational Voretigene Neparvovec Accepted for Filing by FDA

Spark Therapeutics announced that the FDA has accepted for filing the biologics license application (BLA) and granted priority review for voretigene neparvovec, an investigational, potential one-time …

Read the full story