First FDA-Approved Eye Form of Bevacizumab for Wet AMD

Lytenava (bevacizumab-vikg) is a vascular endothelial growth factor (VEGF) inhibitor given by intravitreal injection (into the eye). On the USPI it is indicated for neovascular (wet) age-related macular degeneration (nAMD).

Distinct path — not this carton (fact-only): Compounded bevacizumab (Avastin) prepared for eye use under pharmacy compounding is not the FDA-approved Lytenava ophthalmic vial. Other anti-VEGF eye products (ranibizumab, aflibercept, faricimab, and others) have separate labels. EU/UK Lytenava (bevacizumab gamma) is a related brand with a different proper name — not asserted here as the same carton. Today’s US labelled ophthalmic bevacizumab door is Outlook Therapeutics Lytenava BLA 761320 (bevacizumab-vikg).

The FDA approved BLA 761320 on 24 July 2026. Approval letter signed electronically by Alexander Gorovets, MD, Deputy Director, Office of Specialty Medicine, Office of New Drugs, CDER (ALEXANDER GOROVETS 07/24/2026 10:39:16 AM). Applicant: Outlook Therapeutics, Inc., Iselin, NJ. Letter attention: Jennifer Kissner, PhD, Executive Vice President. U.S. License Number 2292. BLA originally dated/received 29 August 2022; resubmission 29 May 2026 constituting complete response to a 30 December 2025 action letter. Dating period: 36 months from manufacture when stored at 5 ± 3 °C, protected from light. Not referred to an advisory committee (“not the first in its class”). Reference ID 5840468. Novel Drug Approvals for 2026 table row 28.

Where this is taking place

Commercial labelled door today (US): United States — FDA-labelled Lytenava (bevacizumab-vikg) for wet AMD, injected by a qualified physician in a retina / ophthalmology setting with aseptic technique and post-injection monitoring. This is a retina specialist conversation — not a casual retail pickup and not a DIY import or unlabelled compound.

European Union / United Kingdom: Lytenava (bevacizumab gamma) holds EC marketing authorisation (27 May 2024, EU/1/24/1798; MAH Outlook Therapeutics NL B.V. after 2026 transfer) and UK MHRA authorisation. Company materials note commercial launch activity in parts of Europe/UK. Treat EU/UK gamma as a separate labelled path from US vikg unless a clinician and regulator say otherwise.

Outside labelled regions: As of this draft, Health Canada authorisation not confirmed. Do not import on your own.

NORSE TWO — NCT03834753 — Randomized, multi-center, masked, active-controlled. Lead sponsor: Outlook Therapeutics, Inc. Status: COMPLETED. Actual enrolment 228. Country listed: United States. Primary USPI efficacy study for wet AMD.

NORSE EIGHT — NCT06190093 — Multicenter, randomized, masked, controlled; 400 adults; Lytenava vs ranibizumab every 4 weeks × 3 doses. USPI: did not meet pre-specified Week-8 non-inferiority margin of −3.5 letters vs ranibizumab (LS mean difference −2.3; 95% CI −4.0, −0.5). Disclose in any access conversation — do not hide.

The practical US door is a retina specialist who can confirm wet AMD, discuss labelled Lytenava versus other anti-VEGF options (including compounding realities where they still apply), schedule monthly injections, and watch for infection / pressure / vision changes — not treating completed NORSE records as new enrolment.

Approval matrix

Access by country

• United States: Ask a retina specialist about FDA-labelled Lytenava (bevacizumab-vikg). Labelled 24 July 2026 for neovascular (wet) AMD. Recommended dosage: 1.25 mg (0.05 mL of 25 mg/mL) by intravitreal injection once monthly (~28 days). Must be administered by a qualified physician. Single-dose glass vial; each carton for single-eye use only — NDC 82491-025-10 (blue cap). Store refrigerated 2–8 °C in original carton, protect from light; do not freeze. Unopened vial may sit at room temperature up to 12 hours before use. Filter needle / syringe / 30-gauge injection needle prep per USPI §2.3. Monitor intraocular pressure before and after injection; seek urgent care for red, light-sensitive, painful eye or vision change. Prior authorisation and specialty logistics still apply. No list price or copay dollars in this article. Suspected adverse reactions: Outlook Therapeutics 1-833-999-OTLK (6855) or FDA MedWatch 1-800-FDA-1088. This is US commercial labelled supply, not compounded Avastin and not a DIY import.

• Canada: Lytenava authorisation not confirmed. Ask the Canadian retina clinic about labelled anti-VEGF options already available in Canada and what legal paths exist if a Canadian Lytenava label does not yet exist.

• European Union / United Kingdom: Ask a retina clinician about locally labelled Lytenava (bevacizumab gamma) where marketed. Do not assume a US vikg vial is the EU/UK carton.

• Other countries: Authorisation not confirmed in this draft. Do not import on your own.

• If your regulator has not authorised it: do not import on your own. Ask the local clinician about documented special-access / named-patient rules, referral to a labelled country, or waiting — without treating a US vial as a foreign carton.

Who is eligible (from the US label)

This is a wet AMD conversation on the USPI — monthly intravitreal injection by a physician — not dry AMD as a labelled indication on this carton and not pediatric use.

United States (USPI, revised July 2026):

• Indication: Treatment of patients with neovascular (wet) age-related macular degeneration (nAMD).
• Recommended dosage: 1.25 mg (0.05 mL) intravitreal once monthly (~28 days).
• Administration: Ophthalmic intravitreal injection only; qualified physician; aseptic technique; monitor IOP; one vial per eye.
• Contraindications: Ocular or periocular infections; active intraocular inflammation; hypersensitivity to bevacizumab products or Lytenava ingredients.
• Warnings: Endophthalmitis and retinal detachment; IOP increases within 60 minutes; potential arterial thromboembolic event risk with VEGF inhibition.
• Most common adverse reaction (≥4%): conjunctival hemorrhage (4%).
• Pregnancy: May pose embryofetal risk based on anti-VEGF mechanism — give only if clearly needed; discuss contraception (≥3 months after last dose when stopping).
• Lactation: Caution; discuss with clinician.
• Pediatrics: Safety and effectiveness not established.
• Geriatrics: ~70% of Phase 3 Lytenava-treated patients ≥65; no overall efficacy/safety differences with age reported on USPI.

Not labelled on sources confirmed for this draft:

• Pediatric wet AMD.
• Health Canada Lytenava marketing authorisation (not confirmed here).
• Treating EU/UK gamma packs as identical to US vikg without clinician/regulator guidance.
• Treating completed NORSE TWO / NORSE EIGHT as open commercial enrolment.

What the pivotal studies showed (USPI)

Use the USPI for a prescription conversation. Journals are supportive reading.

NORSE TWO — NCT03834753 (primary USPI efficacy):

• Adults with nAMD randomized to Lytenava 1.25 mg monthly for 1 year (N=113) or ranibizumab 0.5 mg monthly ×3 then every 3 months (N=115). Median age 79 years (range 54–98).
• Primary endpoint: proportion gaining ≥15 ETDRS letters from baseline to Month 11.

USPI Table 2 — NORSE TWO primary endpoint:

NORSE EIGHT — NCT06190093:

• 400 adults; Lytenava vs ranibizumab every 4 weeks × 3 doses.
• Week-8 mean BCVA change: Lytenava +3.3 vs ranibizumab +4.5 letters; LS mean difference −2.3 (−4.0, −0.5) — did not meet −3.5-letter NI margin.
• USPI notes Week-12 BCVA increase for Lytenava consistent with NORSE TWO.

Trial-status honesty: NORSE TWO is COMPLETED and supports the US label. NORSE EIGHT’s NI miss is on the label — include it. Neither completed record is a new-enrolment path for labelled commercial starters.

How it is taken (US label — keep this exact)

Research team (from primary sources only)

• Applicant / manufacturer (US): Outlook Therapeutics, Inc., Iselin, NJ — U.S. License 2292.
• Approval letter attention: Jennifer Kissner, PhD, Executive Vice President.
• FDA signer: Alexander Gorovets, MD, Office of Specialty Medicine / OND / CDER.
• RPM named on letter: Michael Puglisi (contact on letter).
• Pivotal study sponsor: Outlook Therapeutics, Inc. (NCT03834753; NCT06190093).
• EU MAH (gamma): Outlook Therapeutics NL B.V. (after 2026 transfer decision).
• AE reporting (US label): Outlook Therapeutics 1-833-999-OTLK (6855).
• Names and phones below are limited to what appears on the USPI, approval letter, and EMA/MHRA sources.

Primary sources

1. Lytenava (bevacizumab-vikg) US Prescribing Information, revised 7/2026 — https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761320s000lbl.pdf
2. FDA BLA Approval Letter 761320, 24 July 2026 (Reference ID 5840468) — https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761320Orig1s000ltr.pdf
3. FDA Novel Drug Approvals for 2026 (row 28 Lytenava) — https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
4. ClinicalTrials.gov NCT03834753 (NORSE TWO); NCT06190093 (NORSE EIGHT)
5. EMA Lytenava EPAR / EC MA EU/1/24/1798 (bevacizumab gamma, 27 May 2024) — https://www.ema.europa.eu/en/medicines/human/EPAR/lytenava
6. Outlook Therapeutics FDA approval press release (24 July 2026) — company secondary