Wet/neovascular age-related macular degeneration global products/pipeline

Last Update: April 29, 2021

Approved therapies

Company Product MoA Indication Approval
Regeneron/Bayer Eylea (aflibercept) Anti-VEGF trap recombinant fusion protein (VEGFR1/2-Fc) Intravitreal injection for wAMD - once every 4 weeks for first 3 months, once every 8 weeks thereafter, potentially once every 12 weeks after one year Nov 2011 (US), Nov 2012 (EU)
Genentech (Roche) Lucentis (ranibizumab) Anti-VEGF-A Fab fragment Intravitreal injection for wAMD - once every 4 weeks, possible up to once every 8-12 weeks after 3-4 initial monthly doses Jun 2006 (US), Jan 2007 (EU)
Genentech (Roche) Avastin (bevacizumab) Anti-VEGF-A mAb Intravitreal injection for wAMD - off-label (once every 4-6 weeks) OFF-LABEL
Novartis Beovu (brolucizumab) Anti-VEGF-A scFv Intravitreal injection for wAMD - once every month for first 3 doses, followed by once every 8-12 weeks Oct 2019 (US), Feb 2020 (EU)
OSI Pharma/Pfizer Macugen (pegaptanib) Anti-VEGF aptamer Intravitreal injection for wAMD - once every 6 weeks Dec 2004 (US), Jan 2006 (EU)

Global pipeline

Company Candidate MoA Indication Phase
Roche Ranibizumab port delivery system (PDS)1 Anti-VEGF-A Fab fragment refillable eye implant wAMD - implant refilled every 6 months III+
Genentech (Roche) Faricimab2 Anti-Ang-2 x VEGF-A bispecific wAMD - intravitreal dose every 8, 12 or 16 weeks III
Kodiak Sciences KSI-3013 Antibody biopolymer conjugate Anti-VEGF-A wAMD - intravitreal injection once every 3, 4 or 5 months after 3 monthly doses III
Regenxbio RGX-3144 NAV AAV8 vector delivering aflibercept fragment wAMD - subretinal treatment - one time treatment III
Opthea OPT-3025 Recombinant VEGFR-3 (VEGF-C, VEGF-D trap) wAMD - intravitreal dose q4w or q8w in combination w/ Ranibizumab or Aflibercept III
Graybug Vision GB-102 (sunitinib) TKI pan-VEGF inhibitor in microparticles/sustained release wAMD - twice per year intravitreal injection IIb
Adverum Biotechnologies ADVM-0226 AAV.7m8-aflibercept wAMD - intravitreal one time therapy I/II
Innovent Biologics IBI3027 Recombinant anti-VEGF x anti-Complement fusion protein (decoy receptors-Fc) wAMD - once every 2 months after 3 monthly doses II
Ocular Therapeutix OTX-TKI (axitinib) TKI sustained release through hydrogel-based implant wAMD - intravitreal implant refilled potentially every 12 months I
AsclepiX Therapeutics AXT1078 α5β1/αvβ3 integrin inhibitor (Tie2 activator/VEGFR2 inhibitor) wAMD - potentially 1-2 injections per year I
Hemera Biosciences/Janssen HMR-1001 AAV CD59 transgene to block complement wAMD - one time treatment complemented with approved Anti-VEGF as needed I
Eyepoint Pharmaceuticals EYP-1901 (Voralanib) TKI sustained released from intravitreallty injected implant wAMD - twice yearly replacement of implant I
Samsung Bioepsis SB11 Ranibizumab (Lucentis) biosimilar wAMD - Lucentis biosimilar I
Ocular Therapeutix OTX-AFS Aflibercept extended delivery formulation wAMD - suprachoroidal injection Preclin9
4D Molecular Therapeutics 4D-150 R100 vector delivering aflibercept fragment wAMD intravitreal injection - one time treatment IND10
Non wAMD indications not listed.
1. Ranibizumab port delivery system - Phase 3 result Over 98% of patients n=244/248 in PDS group able to go 6 months between refill injections. Most common complication mild conjunctival bleb or leak (6.5%). Press release.
2. Faricimab - Two Phase 3 trials. Reported result 25 Jan 2021. Press release.
3. KSI-301 - Ph1b data - BCVA +5.8 letters from baseline at 44 weeks in treated patients. Ph2b/3 DAZZLE KSI-301 once every 3, 4 or 5 months vs aflibercept every 2 months after 3 monthly doses.
4. RGX-314 - Oct 2020 - Ph1/2 result - No immune response or drug-related inflammation. 61 and 85% reduction of anti-VEGF njections at 1 year cohorts 1 and 2, Mean BCVA change of +4 letters and -2 letters from baseline at 1 year, decreased retinal thickness -61 um and -79 um. Protein expression at 1 year, stable at 2 yrs in cohort 3 and over 1 yr in cohorts 4 and 5. Presentation. Phase 2 trial testing suprachoroidal administration has completed enrollment, interim data to be released in Q3 2021.
5. Two Phase III trials, initiated 1H21, combination with either Eylea or Lucentis
6. ADVM-022 - Efficacy durability at 92 weeks with 0 supplemental injections in cohort 1 (High dose). Most patients free from supplemental anti-VEGF injection. April 28 2021 update: a Suspected Unexpected Serious Adverse Reaction (SUSAR) of hypotony with panuveitis and loss of vision has been reported in the Phase 2 trial (INFINITY) in patients with diabetic macular edema (DME). Press release.
7. IBI302 - 2020 AAO virtual meeting, n=31, no SAE or DLT, avg 6 letters from baseline improvement after 28 days. Retinal thickness decreased 141.2 um from baseline, effect lasted 6 weeks from adminstration for some. Ph2 initiating May 1 2021 - China single center study.
8. AXT-107 - Yearly dosing. FIH trial initiating Q420.
9. OTX-AFS - Collaboration with Regeneron.
10. 4D-150 - Ph1 on track to initiate 2H21.

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