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EyePoint Pharmaceuticals (EYPT)

Earnings summaries and quarterly performance for EyePoint Pharmaceuticals.

Research analysts who have asked questions during EyePoint Pharmaceuticals earnings calls.

Recent press releases and 8-K filings for EYPT.

EyePoint Pharmaceuticals Announces Positive DSMC Recommendation for DURAVYU Phase 3 Trials
EYPT
New Projects/Investments
Product Launch
  • EyePoint Pharmaceuticals received a positive recommendation from the independent Data Safety Monitoring Committee (DSMC) for its pivotal Phase 3 program evaluating DURAVYU for wet age-related macular degeneration (wet AMD).
  • The DSMC recommended that both the LUGANO and LUCIA trials continue as planned with no modifications to the protocol, citing no safety signals in the masked safety data.
  • The company anticipates reporting topline 56-week data for the LUGANO trial in mid-2026, with LUCIA data to follow.
  • First patient dosing for DURAVYU in Phase 3 trials for diabetic macular edema (DME) is expected in the first quarter of 2026.
Nov 19, 2025, 12:05 PM
EyePoint Pharmaceuticals Provides Update on DURAVYU™ Clinical Programs and Financial Position
EYPT
Product Launch
Guidance Update
New Projects/Investments
  • EyePoint Pharmaceuticals reported a strong balance sheet with approximately $366 million in cash and equivalents as of September 30, 2025, providing a cash runway into Q4 2027, which extends beyond the anticipated Phase 3 wet AMD data and fully funds the DME pivotal program.
  • The company's lead product, DURAVYU™, has two Phase 3 trials for wet AMD (LUGANO and LUCIA) fully enrolled, with initial data expected in mid-2026.
  • For Diabetic Macular Edema (DME), the Phase 3 program for DURAVYU™ is underway, with the First Patient In (FPI) anticipated in Q1 2026. DURAVYU™ is positioned as the only TKI in development for DME.
  • Commercial scale-up for DURAVYU™ is in progress at a 41,000 sq ft US manufacturing facility in Northbridge, MA, with registration batches underway to support a future NDA filing.
Nov 12, 2025, 3:40 PM
EyePoint Pharmaceuticals Provides Update on Phase 3 Trials and Financial Position
EYPT
New Projects/Investments
Guidance Update
  • EyePoint Pharmaceuticals (EYPT) announced that its wet AMD Phase 3 trials are fully enrolled, with first top-line data expected mid-summer 2026.
  • The company plans to initiate DME Phase 3 trials in Q1 2026, with top-line readouts for both DME trials anticipated in Q4 2027.
  • EYPT highlighted its strong balance sheet with approximately $350 million in cash, providing a runway into Q4 2027 and covering all four Phase 3 trials.
  • The Duravyu program, utilizing a multi-MOA drug (vorolanib) that blocks VEGF receptors and inflammation via JAK1, is positioned as a potential "first in class and best in class" treatment for wet AMD and DME.
Nov 12, 2025, 3:40 PM
EyePoint Provides Updates on Pivotal Wet AMD and Phase 3 DME Trials
EYPT
New Projects/Investments
Product Launch
Guidance Update
  • EyePoint's two pivotal wet age-related macular degeneration (AMD) trials, Lugano and Lugia, are fully enrolled with over 400 patients each. The top-line readout for the Lugano Trial is expected mid-next year (2026), with the Lugia Trial results following shortly thereafter. The company aims for statistical non-inferiority to Eylea.
  • The company plans to initiate two identical Phase 3 trials for diabetic macular edema (DME), COMO and COPRI, in Q1 next year (2026). Top-line results for these DME trials are anticipated in Q4 2027.
  • EyePoint's drug, vorolanib, offers a multi-mechanism of action, providing both anti-VEGF and anti-inflammatory effects by blocking the JAK1 receptor and IL-6, which is considered a key differentiator, particularly in DME.
  • EyePoint intends to self-launch the drug in the United States and will seek a global partner for ex-US markets, expecting to be first to file and first to market.
Nov 10, 2025, 3:30 PM
EyePoint Pharmaceuticals Reports Q3 2025 Results and Provides Duraview Clinical Updates
EYPT
Earnings
Guidance Update
New Projects/Investments
  • EyePoint Pharmaceuticals reported Q3 2025 net revenue of $1 million and a net loss of $59.7 million, or $0.85 per share.
  • The company's cash and investments totaled $204 million as of September 30, 2025, and a $172 million follow-on offering in October is expected to fund operations into Q4 2027.
  • Enrollment for the Phase 3 wet AMD trials (Lugano and Lucia) was completed in July, with top-line data anticipated in mid-2026.
  • The pivotal Phase 3 program for Duraview in DME is set to begin with first patient dosing in Q1 2026.
Nov 5, 2025, 1:30 PM
EyePoint Pharmaceuticals Reports Q3 2025 Financial Results and Clinical Progress
EYPT
Earnings
Guidance Update
New Projects/Investments
  • EyePoint Pharmaceuticals reported total net revenue of $1.0 million for the third quarter ended September 30, 2025, compared to $10.5 million in the prior year period, leading to a net loss of $59.7 million, or ($0.85) per share.
  • As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $204 million.
  • An oversubscribed equity financing in October 2025 generated $172.5 million in gross proceeds, which is expected to extend the company's cash runway into Q4 2027 and fully fund the DME pivotal program.
  • The Phase 3 LUGANO and LUCIA clinical trials for DURAVYU in wet AMD are fully enrolled, with data readout anticipated beginning in mid-2026, and the pivotal Phase 3 DME program is underway with first patient dosing expected in Q1 2026.
Nov 5, 2025, 12:05 PM
EyePoint Pharmaceuticals Reports Q3 2025 Results and Provides Clinical Trial Updates
EYPT
Earnings
Guidance Update
New Projects/Investments
  • EyePoint Pharmaceuticals reported a net loss of $59.7 million (or ($0.85) per share) on $1.0 million in total net revenue for the third quarter ended September 30, 2025.
  • The company completed an oversubscribed equity financing of $172.5 million in October 2025, which is expected to fully fund its DME pivotal program and extend its cash runway into Q4 2027.
  • Phase 3 LUGANO and LUCIA clinical trials for DURAVYU in wet AMD are fully enrolled, with data readout anticipated starting in mid-2026.
  • EyePoint initiated its pivotal Phase 3 program for DURAVYU in diabetic macular edema (DME), with first patient dosing expected in Q1 2026.
Nov 5, 2025, 12:00 PM
EyePoint Pharmaceuticals Initiates Phase 3 Program for DURAVYU in Diabetic Macular Edema
EYPT
New Projects/Investments
Guidance Update
  • EyePoint Pharmaceuticals (EYPT) announced the initiation of its pivotal Phase 3 program for DURAVYU in Diabetic Macular Edema (DME), with first patient dosing anticipated in Q1 2026.
  • The DME program consists of two identical non-inferiority trials, "COMO" and "CAPRI," each designed to enroll approximately 240 patients comparing DURAVYU 2.7mg (redosed every six months) against an on-label 2mg aflibercept control arm.
  • New preclinical data indicates that vorolanib, the active drug in DURAVYU, demonstrates a multi-mechanism of action by inhibiting both VEGF-mediated vascular permeability and IL-6 mediated inflammation.
  • The company reported over $200 million in cash as of September 30, 2025, providing a financial runway into 2027, which extends beyond the anticipated mid-2026 data readout for its fully enrolled Phase 3 wet AMD trials.
Oct 14, 2025, 8:08 PM
EyePoint Announces Phase 3 Program for DURAVYU in DME
EYPT
Product Launch
New Projects/Investments
  • EyePoint Pharmaceuticals has initiated its Phase 3 pivotal trials for DURAVYU (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME), with first patient dosing anticipated in Q1 2026.
  • The Phase 3 program consists of two identical non-inferiority trials, "COMO" and "CAPRI," each enrolling approximately 240 patients to compare DURAVYU 2.7mg against on-label 2mg aflibercept.
  • New preclinical data demonstrates that vorolanib, the active drug in DURAVYU, inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation, positioning it as a potential multi-mechanism of action treatment for wet AMD and DME.
  • DURAVYU is designed for sustained drug delivery, providing consistent daily dosing for at least six months after a single injection.
Oct 14, 2025, 8:01 PM
EyePoint Pharmaceuticals Provides Update on DuraVu Phase III Trials and Financial Position
EYPT
New Projects/Investments
Guidance Update
Product Launch
  • EyePoint Pharmaceuticals anticipates reporting Phase III data for DuraVu (wet AMD) for the Lugano trial by July/August 2026 and for the LUCHIA trial by the end of Q3 2026, with an expected launch in 2027.
  • DuraVu, a Tyrosine Kinase Inhibitor (TKI), represents a new mechanism of action for wet AMD, and its safety profile has been superb with no ocular or systemic serious adverse events reported through Phase II and ongoing Phase III trials.
  • The company held a positive end of Phase II meeting with the FDA in July for its Diabetic Macular Edema (DME) program, with the first patient dosing expected in 2026.
  • EyePoint ended Q2 with $256 million in cash, with guidance extending into 2027, providing nine to twelve months of cash beyond the expected data readouts.
Sep 3, 2025, 8:00 PM