EyePod: Week in Review - September 24, 2023

Welcome to another edition of the Ophthalmology Times EyePod Week in review podcast. In this podcast, we look at some of the week’s top headlines from Ophthalmology Times.com.

FDA approves RYZUMVI for the treatment of pharmacologically-induced mydriasis

The US Food and Drug Administration has approved phentolamine ophthalmic solution 0.75%, (Ryzumvi), for the reversal of pharmacologically-induced mydriasis produced by adrenergic agonist or parasympatholytic agents, or a combination thereof, which has been formulated by Ocuphire Pharma and Viatris.

Formerly known as Nyxol, the freshly renamed Ryzumvi is a preservative-free, stable eye drop, which blocks the α1 receptor within the iris dilator muscle without affecting the ciliary muscle. The result is intended to reverse pharmacologically-induced mydriasis, presbyopia, and night vision disturbances.

In the U S an estimated 100 million eye dilations take place each year for routine check-ups, disease monitoring or surgical procedures of the retina.Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia) and blurred vision, lasting up to 24 hours, which may make it difficult to read, work and drive.

The approval of Ryzumvi arrives following a New Drug Application in December and acceptance of the NDA by the FDA in February.

Outlook Therapeutics requests Type A meeting with FDA

Outlook Therapeutics Inc announced that a Type A Meeting request has been submitted to the FDA to discuss the Complete Response Letter (CRL) dated August 29, 2023, regarding the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.

According to a company news release, in the FDA’s recently issued CRL, although the agency acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, it concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.

The company said in the news release it is committed to working with the FDA to address its concerns.

Kriya announces exclusive license, collaboration, agreement with Everads to advance gene therapies for diseases in ophthalmology, Including GA

Kriya Therapeutics Inc. has entered into an exclusive license, collaboration and supply agreement with Everads Therapy, Ltd to advance Kriya’s portfolio of gene therapies for retinal diseases using Everads' suprachoroidal delivery device.

The therapy is an emerging treatment for diseases in ophthalmology, including geographic atrophy (GA), an advanced form of dry age-related macular degeneration (dry AMD) and affects approximately 1 million people in the United States.

According to a news release, Everads, a private biotech company, has developed a novel technology enabling targeted delivery of therapies to the retina via the suprachoroidal space, an anatomical compartment located between the sclera and choroid that traverses the circumference of the posterior segment of the eye.

Ophthalmology is an area where suprachoroidal delivery is emerging as a non-surgical route of administration, Kriya noted, specifically in the delivery of gene therapy. The company noted this route of administration could enhance the efficiency of gene therapy delivery to the retina while minimizing intraocular inflammation.

ProQR Therapeutics offers update on sale of ophthalmic assets

ProQR Therapeutics N.V. today provided an update that its previously announced agreement to divest the Company’s late-stage ophthalmic assets to Laboratoires Théa has been terminated.

According to a news release, the completion of the transaction was conditional on Théa entering into employment agreements with a number of key ophthalmology personnel from ProQR.

According to Pro Q R, some of the ophthalmology personnel decided not to continue employment at Théa. As a result, the closing condition for the transaction cannot be fulfilled and Théa terminated the agreement.

Orbis International partnering with the Alcon Foundation, OMEGA to improve eye care in Zambia

Orbis International is rolling out a surgical training program in Zambia to aboard its Orbis Flying Eye Hospital to coincide with World Sight Day on October 12, with clinical staff and volunteer faculty providing hands-on simulation and surgical training to eye care professionals from across Zambia.

According to a an Orbis news release, Zambian ophthalmologists trained through Orbis-sponsored and other fellowships will work alongside Flying Eye Hospital staff and volunteer faculty to deliver simulation training to ophthalmology residents.

The project is receiving continuing support from the Alcon Foundation and OMEGA, and will focus on improving adult and pediatric eye care in Zambia, where it's estimated that at least 4% of the population experiences blindness that could be avoided, and there exists only one ophthalmologist per 556,000 Zambians, leaving eye care needs largely unmet.

This project marks the second time the Flying Eye Hospital has held a training project in Zambia – the first taking place in Ndola in 2012 with a focus on pediatric ophthalmology. This will be the first project of its kind to take place in the capital city, Lusaka.