EyePod: Week in Review - August 27, 2023

Welcome to another edition of Ophthalmology Times’ Week in Review, an EyePod podcast that takes a look at some of the week’s top headlines.

FDA issues CRL for Outlook Therapeutics’ ONS-5010

Outlook Therapeutics Inc. announced the FDA has issued a control response letter to the company’s BLA for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet A M D.

According to Outlook Therapeutics, while the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, it determined 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.

Russell Trenary, president and CEO of Outlook Therapeutics, said the company continues to believe in the need to provide the retina community with an FDA-approved bevacizumab treatment option for wet AMD.

Upcoming clinical trial aims to measure effectiveness of Wharton’s jelly eye drops in keratitis treatment

An upcoming clinical trial from TBF Génie Tissulaire aims to assess the impact of eye drops made of Wharton's jelly extract in the treatment of chronic keratitis that failed available therapies.

Wharton’s jelly extract is a primordial mucous connective tissue of the umbilical cord present between the amniotic epithelium and the umbilical vessels. In recent years, it has been found that this substance contains primitive mesenchymal stem cells (MSC) and yields the highest concentration of MSC per milliliter of other allogenic tissues.2

A recent study showed Wharton’s jelly formulation demonstrated the presence of growth factors, cytokines, hyaluronic acid, and extracellular vesicles in clinically relevant quantities, in amounts greater compared with other biologics. And that the presence of multiple factors within one formulation may help reduce inflammation, decrease pain and augment healing of musculoskeletal injuries.

Results from the trial are expected at the end of 2023.

Apellis announces corporate restructuring to drive growth of pegcetacoplan

Apellis Pharmaceuticals Inc announced a corporate restructuring to drive growth of pegcetacoplan injection and pegcetacoplan, which the company said in a release would "position it for long-term success."

According to a company news release, the planned restructuring will include cost reduction initiatives that align with the company’s near-term priorities and are expected to result in up to $300 million in total cost savings through 2024.

Cedric Francois, MD, PhD, co-founder and CEO of Apellis, said in the news release the company is positioning itself for future growth.

According to the company, key elements of the plan include moves to maximize pegcetacoplan injection’s global leadership in geographic atrophy. The company also noted in its news release it continues to focus on backing the continued strong U S commercial launch of pegcetacoplan injection and is preparing for potential ex-US launches, with an anticipated decision on regulatory approval by the European Medicines Agency (EMA) early next year

Apellis also said in the news release it will continue to work with Beam Therapeutics in a collaboration focused on applying base editing to discover novel therapies for complement-driven diseases.

The company also said in its statement it will work to improve its operational efficiencies by aligning the organization to reflect the priorities above, which includes eliminating about 225 employees, or approximately 25% of the current workforce across the organization.

FDA warns against the use of certain illegally marketed methylsulfonylmethane eye drops due to contamination

The FDA is warning consumers to cease use and not purchase Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial contamination, fungal contamination, or both.

According to the FDA, using contaminated eye drops could result in a minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.

As of August 28, Dr. Berne's has received reports of 2 adverse events associated with the use of these eye drops and has initiated a voluntary recall of all lots of MSM Drops 5% and 15% Solution. The company has also issued a voluntary recall of Dr. Berne's Organic Castor Oil Eye Drops and MSM MIST 15% Solution at the consumer level.

According to the FDA, LightEyez Limited has not responded to the FDA’s request for a discussion over the concerns and has taken no action regarding a recall.

Thank you for listening another edition of the Week in Review EyePod podcast. Look for full versions of these and other headlines online at Ophthalmology Times dot com. Check out the print edition of Ophthalmology Times for cutting-edge advancements in surgery, clinical diagnosis, therapeutics, cell and gene therapy, imaging and device technology and other areas of ophthalmology.