- Category: Pipeline
Pipeline
Azura gets positive FDA feedback on NDA submission for MGD ointment
Positive pre-NDA meeting for selenium sulfide ointment precedes planned phase 3 data release in Q1 2026 and regulatory submission in H2 2026.
Pipeline
SeaBeLife and Unither to formulate and develop retinal degenerative disorder formulation
Collaboration focuses on accelerating development of SBL03, formulated for topical delivery to target retinal cell necrosis in GA and dry AMD
Pipeline
Ocular Therapeutix plans for NDA submission of AXPAXLI for wet AMD
Company expects to submit package in Q1 2026, following the anticipated release of positive 1-year data from the phase 3 SOL-1 trial.
Pipeline
EyeYon Medical secures IDE approval for study on first artificial endothelial layer
IDE approval allows for clinical study initiation to evaluate EndoArt, the first-ever synthetic implant for treating corneal edema and improving vision.
Pipeline
ViaLase's IDE trial treats first patient with novel femtosecond laser procedure
Pivotal study is comparing ViaLuxe Laser System with FLigHT as an incision-free canal procedure against SLT for POAG treatment.
Pipeline
FDA clears Zhongmou Therapeutics' IND for RP optogenetic gene therapy
Clearance of ZM-02 marks the first optogenetic gene therapy originating from China to receive U.S. IND authorization.
Pipeline
Belite Bio reports phase 3 topline data on oral tinlarebant for Stargardt disease
DRAGON study is evaluating the once-daily tablet for reducing lesion growth among adolescent patients over a 24-month period.
Pipeline
Precise Bio performs first transplant with 3D-printed cornea implant
Procedure deemed successful in treating first fully blind patient using corneal bio-implant made from corneal endothelial cells.
Pipeline
First autofocus glasses offer lightweight vision correction
New prototype design for prescription-based smart eyewear could be an alternative to traditional progressive lenses.
Pipeline
Ocuvex resubmits FDA CRL for brimonidine tartrate 0.35% NDA
Shared by partner SPARC, update follows 2+ years after the 2022 submission of investigational OAG and OHT eye drop was rejected in July 2023.
Pipeline
Coave Therapeutics debuts lead SCS gene therapy for retinal vascular diseases
In-office, suprachoroidal delivery of CoTx-101 offers potential for durable and long-lasting vision gains in treating wet AMD and DME.
Pipeline
PolyActiva and RareSight to advance long-acting therapies for pediatric IRDs
Collaboration leverages PolyActiva’s PREZIA drug delivery platform to develop NCE-enabling pharmacologic drugs for early-onset vision loss.
Pipeline
SpyGlass Pharma reports long-term data on bimatoprost IOL system
Positive 36-month findings from an FIH trial and 3-month results from a phase 1/2 study support delivery of sustained IOP reduction and drop-free outcomes for OAG, OHT.
Pipeline
Lilly gains exclusive global rights to MeiraGTx's ophthalmic genetic therapies
Strategic partnership extends to MeiraGTx’s investigational genetic medicine for LCA4-AIPLI-associated congenital blindness among pediatric patients.
Pipeline
Outlook Therapeutics resubmits wet AMD BLA for bevacizumab
Company’s third submission of ONS-5010 (bevacizumab-vikg) reportedly addresses prior issues raised in the FDA’s company response letter.
Pipeline
Sydnexis reports phase 3 topline data on SYD-101 eye drop for pediatric myopia
The STAR study met both primary and secondary endpoints for low-dose atropine formulation—just days after the FDA’s NDA rejection.
Pipeline
Viridian submits BLA for veligrotug to treat TED
Company is requesting Priority Review of veli, an IGF-1R monoclonal antibody intravenously-administered to treat chronic TED.
Pipeline
Nanoscope reports 3-year vision improvements for RP optogenetic therapy
Long-term extension from phase 2b/3 RESTORE trial notes potential of MCO-010 as a one-time, gene-agnostic optogenetic therapy.
Pipeline
FDA rejects Sydnexis’ NDA for low-dose atropine drop
SYD-101 still has the potential to become the first pharmaceutical option for progressive myopia for patients aged 3 to 14.
Pipeline