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Q&A: Insights from Rajesh K. Rajpal, MD, on an incision-free keratoconus therapy | Ophthalmology Times
A novel topical, incision-free therapy is now approved to help ophthalmologists slow or halt the progression of keratoconus. (Image credit: AdobeStock/Alessandro Grandini) Glaukos recently received FDA approval for its topical, incision-free therapy for keratoconus (Epioxa) that does not require removal…
Dompé’s NAION program selected for FDA Commissioner’s National Priority Voucher Program | Ophthalmology Times
(Image Credit: AdobeStock) Dompé was selected by the US Food and Drug Administration (FDA) to participate in the Commissioner’s National Priority Voucher (CNPV) program. Because of this selection, Dompé has received a voucher granting a significantly shortened review timeline for marketing…
Stoke Therapeutics announces 2-year data from the natural history study, FALCON | Ophthalmology Times
(Image Credit: AdobeStock) Stoke Therapeutics announced 2-year data from the FALCON study, a prospective natural history study in people with autosomal dominant optic atrophy (ADOA). FALCON was a multicenter, 24-month, prospective natural history study of those aged 8 to 60…
AAO 2025: Kenneth C. Fan, MD, sees vision gains with MCO-010 in Stargardt disease | Ophthalmology Times
Kenneth C. Fan, MD, MBA, of Retina Consultants of Texas, highlighted findings from the STARLIGHT study at the American Academy of Ophthalmology 2025 annual meeting, held October 18-10, in Orlando, Florida. He focused on the use of MCO-010 optogenetic therapy…
Glaukos receives FDA approval for Epioxa topical therapy for keratoconus | Ophthalmology Times
Glaukos’ FDA-approved Epioxa topical therapy offers a first-of-its-kind, incision-free treatment for patients with keratoconus, according to the company. Glaukos announced that the FDA has approved the new drug application for its topical drug therapy (Epioxa HD/Epioxa) for keratoconus.1,2 This approval…
FDA grants breakthrough therapy designation to Nacuity’s NPI-001 for retinitis pigmentosa | Ophthalmology Times
(Image Credit: AdobeStock) The US Food and Drug Administration (FDA) has granted Nacuity Pharmaceuticals’ N-acetylcysteine amide tablets (NPI-001) breakthrough therapy designation. NPI-001 is Nacuity’s investigational therapy for the treatment of patients with retinitis pigmentosa (RP). It is a GMP-grade formulation…
AAVantgarde’s AAVB-039 gene therapy to treat Stargardt disease receives orphan drug status from FDA | Ophthalmology Times
(Image Credit: AdobeStock/artacet) The US Food and Drug Administration (FDA) has granted AAvantgarde’s AAVB-039 Orphan Drug Designation (ODD) and has also received Clinical Trial Authorisation (CTA) approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). AAVB-039 is an…
Q&A: The ARCHER trial and the importance of continued GA research | Ophthalmology Times
(Image credit: AdobeStock/J Bettencourt) In conversation with Sydney M. Crago, Managing Editor of Ophthalmology Times, David R. Lally, MD, spoke about his presentation at the 2025 Retina Society meeting, which highlighted the results from the ARCHER trial (NCT04656561) of ANX007…
Q&A: Frank Holz shares how innovation showcased at EURETINA brings hope for patients with GA | Ophthalmology Times
Photo of Frank Holz at the 2025 EURETINA meeting Frank Holz, MD, FEBO, FARVO, a retina specialist from Bonn, Germany, discusses the EURETINA meeting, highlighting groundbreaking advancements in retinal disease treatments. With a record attendance of over 11,000, the conference…
Intravitreal complement inhibitor treatment for GA viewed favorably by patients | Ophthalmology Times
(Image Credit: AdobeStock) A new British study reported that treatment with intravitreal complement inhibitors (IVCIs) for geographic atrophy (GA) was viewed favorably by patients if the treatment was thought to impart visual benefits,1 according to first author Christiana Dinah, BSc,…