NexThera, Oculis and Bayer Report Advances in Retinal Disease Therapies

Eye drops and fewer shots: NexThera, Oculis and Bayer move the needle in retinal disease care.

NexThera, Bayer and Oculis have each reported new clinical and regulatory milestones for therapies targeting retinal diseases including wet age-related macular degeneration (AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO).

The treatments include novel topical delivery methods and extended-dosing anti-VEGF injections, with potential to reduce treatment frequency and enhance convenience.

NexThera launches wet AMD trial for NT-1O1

NexThera (Busan, South Korea) has initiated a U.S.-based Phase I/IIa clinical trial to evaluate NT-101, an investigational eye drop therapy for wet AMD. The condition is commonly treated with regular intravitreal anti-VEGF injections, which may require frequent visits and pose adherence challenges for some patients.¹On April 8, NexThera enrolled its first patient at a clinical site in Pennsylvania, with a goal of treating 30 patients across multiple states. NT-101 is formulated with a peptide and protein-based platform designed to deliver the drug to retinal tissues via topical administration, according to the company.

The trial includes low- and high-dose versions administered twice daily for four weeks, followed by a four-week observation period, measuring key efficacy indicators like central subfield thickness (CST) and best-corrected visual acuity (BCVA).

“NT-101 is the first drug candidate developed based on NexThera’s innovative eye drop delivery platform technology. This platform enables the targeted delivery of the active drug ingredient to the retinal tissue, located at the innermost part of the eye, thereby offering a safer and more convenient alternative to the conventional intravitreal injection method,” said the company in a statement.

Oculis completes Phase III enrollment for DME eye drop

Meanwhile, Oculis (Zug, Switzerland) has completed enrollment in its pivotal Phase III DIAMOND-1 and DIAMOND-2 trials assessing OCS-01, a topical eye drop developed using its proprietary OPTIREACH^® technology, for DME.

With over 800 patients enrolled across 119 global sites—most of them in the United States—this is the first late-stage program of its kind for a non-invasive DME therapy.²OCS-01 is a high-concentration dexamethasone formulation developed to target the retina via eye drops, a route that avoids injections or implants.

Its OPTIREACH^® solubilizing technology overcomes traditional challenges of topical drug delivery to the back of the eye by improving drug solubility, enhancing surface retention and enabling passage to the posterior segment—all critical for reaching the retina effectively.

The ongoing Phase 3 DIAMOND trials will follow patients for 52 weeks, with topline data expected by Q2 2026 and an NDA submission to the Food and Drug Administration (FDA) to follow. If approved, OCS-01 could be the first non-invasive therapy for DME, potentially expanding treatment options beyond injections or implants.

Bayer’s aflibercept 8 mg targets longer relief for RVO

Not to be left behind, Bayer (Leverkusen, Germany) has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for aflibercept 8 mg for macular edema secondary to RVO.³This extended-interval formulation of its blockbuster Eylea product showed strong results in the Phase III QUASAR study, where patients receiving injections every 8 to 12 weeks achieved visual outcomes non-inferior to those receiving monthly injections of aflibercept 2 mg.

According to trial data, 90% of patients on aflibercept 8 mg maintained the extended 8-week dosing through 36 weeks, and nearly 70% reached a 12-week interval. Bayer is also seeking approval to extend dosing intervals to up to six months for other indications like wet AMD and DME, based on additional trial data from its PULSAR and PHOTON studies.

“Once approved, aflibercept 8 mg expands durable treatment options alleviating the burden of frequent injections and clinic visits for patients living with retinal vein occlusion,” said Christine Roth, executive vice president of Global Product Strategy at Bayer.

Aflibercept 8 mg (marketed in the U.S. as Eylea HD) is already approved in over 50 countries for nAMD and DME.