Allergic Conjunctivitis

• FDA approval · 2024-04-24
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for Loteprednol etabonate, a generic ophthalmic corticosteroid for inflammatory eye…

• CLINICAL_TRIALS trial_result · 2024-04-18
  Clinical Trial Update: The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis [Phase 3]

  Phase 3 clinical trial update for INVIGORATE 2 evaluating efficacy and safety in seasonal allergic conjunctivitis has completed.

• FDA approval · 2024-04-09
  FDA Approved: OLOPATADINE — Supplemental Application (Somerset Therapeutics, LLC)

  The FDA approved a supplemental application for olopatadine (ANDA206306) submitted by Somerset Therapeutics, LLC. The snippet indicates a su…

• FDA approval · 2024-03-01
  FDA Approved: ALCAFTADINE — Original Application (Gland Pharma Limited)

  FDA approves ALCAFTADINE under an Original Application (ANDA) from Gland Pharma Limited.

• FDA approval · 2024-01-09
  FDA Approved: FLUOROMETHOLONE OPHTHALMIC SUSPENSION — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC’s fluorometholone ophthalmic suspension under an Original Application (ANDA216348).

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• CLINICAL_TRIALS trial_result · 2023-12-05
  Clinical Trial Update: A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis [Phase 2]

  Phase 2 clinical trial update for NS2 in allergic conjunctivitis shows completed status with results posted.

• CLINICAL_TRIALS trial_result · 2023-12-01
  Clinical Trial Update: A Study of TL-925 for the Treatment of Allergic Conjunctivitis [Phase 2]

  Phase 2 clinical trial update for TL-925 in allergic conjunctivitis (status unknown).

• CLINICAL_TRIALS trial_result · 2023-08-04
  Clinical Trial Update: Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis [Phase 2]

  Phase 2 trial evaluating the safety and efficacy of a ketotifen 4.0% patch compared with placebo, olopatadine solution, and artificial tears…

• FDA approval · 2023-06-23
  FDA Approved: ALCAFTADINE — Original Application (Aurohealth LLC)

  FDA approved the Original Application for ALCAFTADINE by Aurohealth LLC, establishing a generic version of the antihistamine eye drop. The a…

• FDA approval · 2023-06-07
  FDA Approved: RYALTRIS — Supplemental Application (HIKMA SPECIALTY USA INC.)

  FDA approved a supplemental application for RYALTRIS (olopatadine hydrochloride and mometasone furoate) submitted by Hikma Specialty USA Inc…

• FDA approval · 2023-04-12
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (ARMAS PHARMACEUTICALS INC.)

  FDA approved Loteprednol etabonate ophthalmic suspension from Armas Pharmaceuticals Inc. under an Original Application for use in ocular inf…

• FDA approval · 2023-04-05
  FDA Approved: BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% from Alembic Pharmaceuticals as an original application for the treatment of itch…

• CLINICAL_TRIALS trial_result · 2023-03-16
  Clinical Trial Update: Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children [Phase 3]

  Phase 3 trial assessing bilastine ophthalmic solution in children for allergic conjunctivitis has completed.

• CLINICAL_TRIALS trial_result · 2023-01-09
  Clinical Trial Update: A Study of ADX-102 in Subjects With Allergic Conjunctivitis [Phase 2]

  Phase 2 trial of ADX-102 in allergic conjunctivitis completed; results posted in 2023.

• FDA approval · 2022-12-19
  FDA Approved: NAPHCON A — Supplemental Application (Alcon Laboratories, Inc.)

  The FDA approved a supplemental application for NAPHCON A (napahzoline hydrochloride and pheniramine maleate) from Alcon Laboratories, Inc. …

• CLINICAL_TRIALS trial_result · 2022-12-15
  Clinical Trial Update: Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment [Phase 4]

  Phase 4 trial comparing bepotastine 1.5% preservative-free formulation versus olopatadine 0.2% with benzalkonium chloride for allergic conju…

• FDA approval · 2022-11-02
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic promethazine hydrochloride under an original ANDA. The approval authorizes marketing of the gen…

• CLINICAL_TRIALS trial_result · 2022-10-17
  Clinical Trial Update: Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis [Phase 2]

  Phase 2 trial evaluating PRT-2761 for allergic conjunctivitis has been completed with results posted in 2022.

• FDA approval · 2022-09-23
  FDA Approved: EYE ALLERGY RELIEF — Supplemental Application (DOLGENCORP, LLC)

  FDA approved a supplemental application for Eye Allergy Relief (pheniramine maleate and naphazoline hydrochloride) from DolgenCorp, LLC. The…

• CLINICAL_TRIALS trial_result · 2022-09-02
  Clinical Trial Update: A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis [Phase 4]

  Phase 4 clinical trial comparing Pataday Once Daily Relief Extra Strength to Flonase Allergy Relief in allergic conjunctivitis has completed…

• FDA approval · 2022-08-29
  FDA Approved: LASTACAFT — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for LASTACAFT (alcaftadine) from Allergan, Inc.

• CLINICAL_TRIALS trial_result · 2022-08-25
  Clinical Trial Update: Therapeutic Effect of Tacrosolv in Patients With Allergic Rhinoconjunctivitis [Phase 2]

  Phase 2 clinical trial update on Tacrosolv for allergic conjunctivitis and allergic rhinitis has completed.

• FDA approval · 2022-08-02
  FDA Approved: FLAREX — Supplemental Application (Eyevance Pharmaceuticals)

  FDA approved a supplemental application for FLAREX (fluorometholone acetate) submitted by Eyevance Pharmaceuticals.

• CLINICAL_TRIALS trial_result · 2022-05-03
  Clinical Trial Update: A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis [Phase 4]

  Phase 4 trial comparing Pataday Once Daily Relief Extra Strength to Claritin for allergic conjunctivitis has completed.

• CLINICAL_TRIALS trial_result · 2022-04-13
  Clinical Trial Update: DEXTENZA Therapy for Treatment of Allergic Conjunctivitis [Phase 4]

  Phase 4 trial update for DEXTENZA therapy in allergic conjunctivitis has completed.