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

Last Update: July 28, 2022

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)
Samsung Bioepis Byooviz (Ranibizumab-nuna) Anti-VEGF-A Fab fragment - BIOSIMILAR Intravitreal injection for wAMD - once every 4 weeks, possible up to once every 8-12 weeks after 3-4 initial monthly doses Sep 2021 (US)
Genentech (Roche) Susvimo (Ranibizumab) Anti-VEGF-A Fab fragment refillable eye implant (port delivery system) Implant for wAMD refilled every 6 months Oct 2022 (US)
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)
Genentech (Roche) Vabysmo (faricimab) Anti-Ang-2 x VEGF-A bispecific Intravitreal injection for wAMD and DME - intravitreal dose every 4 weeks for first 4 doses then either 8, 12 or 16 weeks Jan 2022 (US)

Global pipeline

Company Candidate MoA Indication Phase
Kodiak Sciences KSI-3011 Antibody biopolymer conjugate Anti-VEGF-A wAMD - intravitreal injection once every 3, 4 or 5 months after 3 monthly doses III
Regenxbio RGX-3142 NAV AAV8 vector delivering aflibercept fragment wAMD - subretinal treatment - one time treatment III
Opthea OPT-3023 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
Clearside Biomedical CLS-AX (axitinib)9 Axitinib injectable suspension wAMD - suprachoroidal injection I/IIa
Adverum Biotechnologies ADVM-0224 AAV.7m8-aflibercept wAMD - intravitreal one time therapy II
Innovent Biologics IBI3025 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 AXT1076 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 Preclin7
4D Molecular Therapeutics 4D-150 R100 vector delivering aflibercept fragment wAMD intravitreal injection - one time treatment IND8
Non wAMD indications not listed.
1. KSI-301 - Ph3 data press release - did not meet PO of non-inferiority to aflibercept given every 8 weeks. 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.
2. 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.
3. Two Phase III trials, initiated 1H21, combination with either Eylea or Lucentis
4. 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. Company amended IND July 6 2022, initiating Ph2 in wAMD in Q322. Press release.
5. 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.
6. AXT-107 - Yearly dosing. FIH trial initiating Q420.
7. OTX-AFS - Collaboration with Regeneron.
8. 4D-150 - Ph1 on track to initiate 2H21.
9. CLS-AX - OASIS trial - dosing completed July 26 2022. Final data expected Q422.

scFv = Single chain variable fragment. TKI = Tyrosine kinase inhibitor.

--Report an error or missing drug--


Have feedback? Tweet or DM me @blackseedbio on Twitter, or contact me here.

If you want to get notified when updates are available, please consider subscribing.

SUBSCRIBE