News

Harrow Health Inc. announced it has reached an agreement to purchase the exclusive U.S. commercial rights to 5 ophthalmic drugs from Novartis AG for up to $175 million, the company announced today.

As we approach the end of 2022, members of the Ophthalmology Times Europe® Editorial Advisory Board were asked to predict developments in their ophthalmic specialties and interests. A focus is our ageing population, while efficiency and productivity are also on their minds. The board members agree that one of the major challenges in the year to come will be the large number of patients awaiting diagnosis and treatment, which is only going to increase with the rising average life expectancy worldwide.

In a multicenter phase 1/2 safety study conducted in the US and UK, researchers conducted a dose-escalation trial of AAV5-RPGR that included low, intermediate, and high doses of the gene therapy administered to 3, 4, and 3 adults, respectively.

The results represent a major step towards first in-human clinical studies for this program - the first potential therapy for patients with geographic atrophy secondary to AMD that addresses the underlying causes of the disease.

According to the AAO and Verana Health, the partnership seeks to increase clinical trials access, accelerate recruitment, and advance ophthalmic research.

According to a team of German investigators, visual cells in the human retina may not simply die in some diseases, but are mechanically transported out of the retina beforehand.

According to the company, OPGx-001 is Opus’ first program to enter clinical evaluation and is designed to address vision loss due to mutations in the LCA5 gene, which causes one of the most severe forms of early-onset blinding disease Leber congenital amaurosis.

A breakthrough gene therapy approach, SPVN06 is aimed at stopping or slowing disease progression in patients affected by IRDs and dry age-related macular degeneration (AMD), regardless of their genetic background.

According to a news release, the findings build on evidence from a previous study led by the Johns Hopkins researchers that found potentially a third of patients with wet AMD could safely pause therapy after one year of monitoring by a physician.

Ophthalmologists are now armed with new therapies to fight retinal disease.

According to physician, this therapeutic may prove to be a treatment option for these diseases.

Investigators examining end-stage RP witness the partial visual recovery in 2 patients.

Discovery CORE and its AI models have been designed to accelerate data analysis and help clinical and academic researchers collaborate more efficiently in real time with their peers on medical and imaging datasets.

In an effort to educate the public on geographic atrophy, Prevent Blindness has created a variety of resources in English and Spanish.

The company is currently developing sustained release ophthalmic therapeutics aimed at reducing the frequency of intravitreal injections required to treat a wide range of retinal diseases.

Intravitreally injected anti-VEGF drugs are undergoing investigation as researchers look for new treatment options.

According to the company, the deal adds pharmaceutical research and development capabilities and further expertise for future product pipeline. It also expands Alcon’s presence in the $20 billion global ophthalmic pharmaceutical category.

The company noted the updated PDUFA goal date is February 26, 2023. The FDA also reiterated that they do not plan to hold an advisory committee meeting to discuss the application.

According to the company, LBS-008 is an orally administered tablet intended as an early intervention to slow disease progression in patients affected with Stargardt disease and dry age-related macular degeneration.

Delaying the disease can also delay any onset of vision problems, including diabetic retinopathy and diabetic macular edema.

According to the company, ROP Check builds upon its pediatric retina screening portfolio, adding digital management (schedule, document, bill, and transfer) for treating patients with retinopathy of prematurity.

Artificial intelligence in a primary care and clinic settings increases the likelihood of catching diabetic retinopathy in underinsured patients, resulting in increased successful referrals.

Being able to visualize and evaluate the retinal periphery provides a better understanding of the disease status and supports a better treatment decision.

OPT-302 in combination with standard-of-care anti-VEGF-A agents shown to improve visual acuity, anatomic endpoints.

In both patients and controls, investigators measured retinal nerve fiber layer thickness, foveal avascular zone area, and vessel density in the superficial capillary plexus, deep capillary plexus, and radial peripapillary capillary plexus.

The submission of 24-month efficacy data from DERBY and OAKS is classified as a Major Amendment to the New Drug Application, which delays the PDUFA target action date until February 2023.

An end-of-week review of retina news and stories from October 29-November 3, 2022.

RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions.

In a real-world setting, eyes with AMD with a relatively good initial best-corrected visual acuity and no fibrovascular pigment epithelial detachment sustained or improved BCVA after anti-VEGF therapy within 3 years of follow-up.