Kodiak’s KSI-301 Has Narrower Path Forward After Phase II/III Failure In Wet AMD

Monthly dosing remains a possibility in wet age-related macular degeneration, though diabetic macular edema and retinal vein occlusion look more promising.

Eye — Kodiak announced results of its Phase IIb/III DAZZLE study in wet AMD • Source: Shutterstock

Kodiak Sciences Inc. still has options for KSI-301, but they are narrower now that the Phase IIb/III DAZZLE study in wet age-related macular degeneration (AMD) failed to meet its primary endpoint of showing non-inferior visual acuity gains for patients dosed on extended regimens compared with Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept). Now the drug’s most likely path forward is in diabetic macular edema (DME) and retinal vein occlusion (RVO), as well as potentially monthly dosing for wet AMD based on an ongoing trial.

The company announced the results of DAZZLE on 23 February, adding that the failure to meet the primary endpoint came...

Spain’s SpliceBio Secures Sanofi and Roche Support In $135m Financing

11 Jun 2025

• By Kevin Grogan

Series B cash will be used to advance its Stargardt disease gene therapy.

Santen Sees Potential In Myopia Market After Ryjunea Approval

06 Jun 2025

• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

29 May 2025

• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

Lilly To Diversify Pain Pipeline With SiteOne Acquisition

27 May 2025

• By Joseph Haas

Deal snapshot: With several internal non-opioid pain candidates in Phase II or earlier, Lilly looks to add R&D potential in pain with $1bn buyout of SiteOne.